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Location: Bengaluru, India Purpose The ERP System Operations Project Manager leads the international arm of ClinChoice’s Global ERP Administration function and collaborates with the company’s international cross-functional teams to support users in their day-to-day use of Microsoft Dynamics 365. The role also works with the company’s ERP development team and third-party vendor to maintain and optimize ERP system operations. Responsibilities Lead the International ERP Administration team and oversee first-level technical and functional support for international users of Microsoft Dynamics 365 modules. Collaborate closely with international cross-functional teams across multiple entities and with key ERP stakeholders to diagnose system issues, recommend solutions, and continuously identify opportunities to improve ERP performance. Analyze business requirements; prepare functional specifications and design documentation; and manage change requests, service requests, and budget alignment and approvals. Manage the full system project lifecycle, including project kickoff, planning, issue tracking, timeline management, and testing coordination. Oversee testing activities and release schedules to ensure the successful delivery of system enhancements. Manage ERP timesheet operations and support resource planning. Monitor company-wide timesheet and resource-planning processes to ensure satisfactory monthly completion and approval rates. Continuously evaluate and optimize timesheet-management processes and training programs. Manage ERP user permissions and oversee the development, maintenance, and review of system-related standard operating procedures. Manage the tracking and prioritization of open requests, ensuring the timely resolution of critical system issues. Lead and facilitate ERP project meetings with stakeholders at all organizational levels. Design, develop, and deliver company-wide application training programs, including monthly ERP timesheet training for new hires, line managers, and project functional leads. Evaluate, initiate, and lead cross-functional standardization and automation initiatives that drive continuous business process improvement and operational efficiency. Skills and Qualifications Bachelor’s degree or higher in information systems, computer science, accounting, finance, or a related field. Minimum of 8-12 years of experience in ERP operations or finance systems support. Hands-on experience with Microsoft Dynamics 365 is highly preferred. Strong written and verbal communication skills, with excellent analytical and problem-solving abilities. Proven ability to lead cross-functional initiatives and manage multiple projects simultaneously. Experience managing system implementation, maintenance, and continuous improvement initiatives. Advanced proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook. Ability to work effectively as a collaborative team member and support operations across multiple time zones. Business-level proficiency in English is required, and proficiency in Mandarin Chinese is preferred for daily collaboration with the ERP vendor and the China IT team, along with availability across time zones during the financial close period Flexibility to support U.S. and European time zones.

Location: City, State/County - Country Responsibilities: Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval Responsible for reviewing and writing CMC modules 2 and 3 Exposure to EU and CIS region in regulatory filings Herbal product development background Manage and coordinate product life cycle management Ensure regulatory compliance with local regulatory requirements Foster and maintain professional relationships with the health authorities Provide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessary Maintain regulatory work processes and tracking tools that improve performance levels and transparency Exposure in writing of Product Quality Review Promote regulatory intelligence in both local and regional initiatives Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas Execution of regulatory strategies (local and regional) that are in line with the business plan Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met Ensure adherence to timelines and quality set parameters R eview of formulation, generation of ingredient list, and claims per set standards Compilation and review of labeling components per SOP Deliverables: CMC modules 2 and 3 Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval Review of CMC modules Execution of regulatory strategies (local and regional) that are in line with the business plan Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period. Review of formulation, generation of ingredient list, and claims per set standards Compilation and review of labeling components per SOP Experience/Qualifications: Bachelor’s/Master’s degree in Life Science/Pharma Six to eight years of relevant work experience RAPS certification is desirable

Location: Canada ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Scientist, Risk Management & Safety Surveillance on a permanent basis. Responsibilities Position Summary The scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). He/She will have in- depth product knowledge and will support Safety Management Team (SMT) deliverables as required. Daily activities involve planning, conducting meetings, database searching, aggregate safety analysis and case level review, writing, and project management/coordination of strategic safety documents. He/She will partner with team members, stakeholders including Medical Safety Officers (MSOs), and a vendor. Primary Responsibilities: •     Ensure timely, quality reports/safety analyses related to core deliverables with oversight as appropriate •     Collaborate with Therapeutic Area Safety Head (TASH), MSO, Safety Surveillance Physician (SSP) and other stakeholders on strategy development •     Initiate, conduct, and oversee searches of internal and external databases •     Perform and/or lead aggregate safety analysis and case level review •     Author, contribute, and coordinate the preparation of core safety deliverables •     Ensure commitments (e.g., Pharmacovigilance Agreements (PVAs) and assessment reports) are met •     Partner with vendor to develop reports/deliverables •     Provide SMT support as needed •     Act as ad hoc member for assigned products as appropriate •     Recognize potential issues and or safety issues and escalate to the attention of    the report owner, line manager, or MSO •     Ability to understand nature of adverse drug reactions and complex associations •     Maintains a high level of flexibility and ability to reprioritize ones work and others •     Attention to detail and ability to analyze data in broader context •     Ability to work across multiple functions and therapeutic areas •     Review regulatory assessor comments/requests and accommodate/address as appropriate with guidance Training/Meetings/Department Initiatives: •     Participate in cross-functional training of relevant stakeholders •     Attend departmental meetings and trainings •     Participate in department and/or cross-functional initiatives Secondary Responsibilities: •     Safety Management Teams (SMT) for assigned products - Lead SMT meeting.  Lead and drive discussions and formulate decisions along with core members •     Risk management plans - Provide guidance on RMP creation and updates.  Reviews and align approvals with oversight leads of the Risk Management plan •     Periodic Benefit Risk Evaluation Report (PBRER)/ Periodic Safety Update Report (PSUR) - Reviews and align approvals with lead oversight.  Leads strategy of the PBRER process. •     Health authority queries -Work with MSO, scientist to organize data, review cases, literature, write Marketing Authorization Holder (MAH) comments •     Participating Affiliate Core Data Sheets (CCDS), US and EU prescribing information updates - Form part of the label working group and provide guidance related to the label updates. •     Signal Validation and Evaluations - Work with Scientist to review preliminary data to determine if the signal is valid and would require further evaluation. Lead and drive the signal evaluation process •     IB updates for safety sections - Evaluate clinical data for ADRs, assist with section 5 and Reference Standard Information (RSI) tables as needed •     DSURs - Reviews and aligns Safety approvals with lead oversight. •     Addendum to Clinical Overviews - Provide support with review, and characterization of risks, data review •     Literature reviews for class effects and ad hoc reports -Review articles and create MAH Comments for assessment of the articles •     Product Safety Strategy (PSS) - Review the risks documented in the PSS and oversee the updates as necessary. Align approval of the PSS updates with oversight. •     Handing Level 2 Escalations/HHE - Participate in level 2 escalations and assess whether there is a Safety impact and an HHE is needed. Lead and drive the HHE process. •     Clinical Development Team (CDT), Local Working Group (LWG) and other cross functional meeting participation - Participate and provide safety inputs as required Minimum Qualifications Education/Experience: ·       Bachelor’s degree in Health or Biomedical Science and six to eight years of industry experience or equivalent, or Advanced degree (preferred) in Health or Biomedical Science and four to six years of industry experience or equivalent) ·       Physician (MD or equivalent) generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs). Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience is preferred. ·       Clinical/medical writing or pharmacovigilance experience preferred ·       Strong English verbal and written communication skills. ·       Demonstrated knowledge of principles of drug development, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development as well as global safety regulations, is highly preferred. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-PB1 #LI-Remote AI: Our hiring process includes AI screening for keywords and minimum qualifications. Recruiters review all results. Vacancy: This posting is for an existing vacancy. Open Date: 22-09-2026 Close Date: 06-11-2026 The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions): ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity.  We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection. The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Canada Pay Range $80 — $115 CAD

Location: United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Regulatory Affairs CMC Consultant for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role We are seeking an experienced Regulatory CMC professional to support Client’s pharmaceutical and self-care portfolio. This role will provide regulatory CMC expertise across new product development, lifecycle management, post-approval changes, and global regulatory submissions . The successful candidate will partner closely with Regulatory Affairs, R&D, Supply Chain, Quality, and other cross-functional teams to develop and implement effective CMC regulatory strategies. Key Responsibilities Lead or support Regulatory CMC strategy for new product development and lifecycle management programs. Provide CMC regulatory guidance for pharmaceutical and self-care products across global markets. Develop, review, and maintain CTD Module 2.3 and Module 3 documentation. Prepare and review CMC content for regulatory submissions, including new applications, variations, and post-approval changes. Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements. Provide regulatory guidance on manufacturing, formulation, analytical methods, specifications, stability, packaging, and related CMC topics. Act as the CMC representative on cross-functional product development and lifecycle management teams. Partner with R&D, Manufacturing, Quality, Supply Chain, and Regulatory colleagues to resolve CMC issues and develop practical regulatory strategies. Support regulatory agency interactions and responses to CMC-related questions, as required. Manage regulatory risks and develop appropriate mitigation and contingency strategies. Ensure ongoing regulatory compliance and successful implementation of approved CMC changes. Contribute to process improvements, simplification initiatives, and development of effective CMC ways of working. Required Qualifications Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences , or a related discipline. Strong experience in Regulatory Affairs CMC and/or pharmaceutical product development . Experience with CTD Modules 2.3 and 3 and CMC submission documentation. Knowledge of global regulatory requirements related to pharmaceutical CMC. Experience with new product development and post-approval lifecycle management . Strong understanding of CMC regulatory requirements involving manufacturing, formulation, analytical testing, specifications, and stability. Experience working effectively with cross-functional teams. Strong project management, communication, problem-solving, and stakeholder-management skills. Preferred Experience Experience supporting OTC, self-care, consumer health, or pharmaceutical products . Experience working across multiple global markets and regulatory regions. Experience interacting with health authorities or supporting responses to regulatory questions. Ability to influence cross-functional teams and provide clear, practical regulatory guidance. What You’ll Bring We are looking for someone who combines strong technical CMC expertise with excellent regulatory judgment, communication, and collaboration skills. The ideal candidate will be comfortable working in a global, cross-functional environment and managing multiple CMC programs and priorities. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-PB1 #LI-Remote #Contract

Location: United States ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a Principal Pharmacokinetics Scientist to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. The ideal candidate will possess a deep understanding of pharmacokinetics (PK) and pharmacodynamics (PD) theory and practice and will play a key role in the design, execution, and analysis of clinical pharmacology studies and other projects involving PK/PD. This position requires strong leadership in study concept development, protocol design, and the ability to work collaboratively with both internal teams and external clients. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Key Responsibilities: Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans, and creating modeling and simulation plans. Conduct PK-PD, Pop PK-PD, and related analyses to support clinical trials, ensuring accurate data interpretation and integration into regulatory filings, clinical publications, and presentations. Provide technical expertise and support in the use of standard PK and PD data analysis software, including Phoenix WinNonlin, NLME, R/R Studio, Monolix, NONMEM, and similar tools. Collaborate closely with clients to understand project needs, provide expert guidance on clinical pharmacology, and deliver high-quality outcomes. Prepare and review comprehensive PK/PD analysis reports, ensuring clear and precise communication of study results to clients and stakeholders. Apply significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology to ensure compliance and support regulatory submissions. Work effectively in cross-functional teams, including bioanalytical scientists, biostatisticians, and clinical operations, to ensure seamless project execution. Provide mentorship and leadership to junior pharmacologists, contributing to the development and implementation of best practices within the team. Stay current with advancements in clinical pharmacology, applying the latest knowledge to enhance project outcomes and client satisfaction. Qualifications: PhD in pharmaceutical sciences, pharmacology, life sciences, clinical pharmacology, pharmacokinetics, or a related discipline, with at least 3 years of relevant research or clinical experience in clinical pharmacology and pharmacokinetic-pharmacodynamic modeling within the pharmaceutical or biotechnology industry. PharmD in a relevant discipline with a minimum of 5 years of experience in clinical pharmacology and PK/PD modeling and simulation. Alternatively, a Master’s degree in a related field with at least 7 years of relevant experience in Clinical Pharmacology and Modeling & Simulation. Robust knowledge of pharmacokinetics, pharmacodynamics, translational sciences, and PK/PD data analysis. Hands-on experience and expertise with standard PK and PD data analysis software such as Phoenix WinNonlin, NLME, R/R Studio, Monolix, and NONMEM. Strong communication and organizational skills, with the ability to present complex data to both scientific and non-scientific audiences. Proven ability to manage multiple projects simultaneously and work effectively in a dynamic, client-oriented environment. Preferred Qualifications: Experience in working across a variety of therapeutic areas. Prior experience working in a CRO setting is highly desirable. Relevant certifications in clinical pharmacology or related disciplines are a plus. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Principal #Permanent

Location: United States J ob Title: Director, Regulatory Affairs, Pharmaceuticals Employment Type: Permanent Location: 300 Welsh Road, Building 5, Suite 201, Horsham, PA 19044, USA A bout ClinChoice ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director, Regulatory Affairs (Hybrid) on a permanent basis. DUTIES & RESPONSIBILITIES : As the Director of Regulatory Affairs for Pharmaceuticals & Biotech, you will have the opportunity to formulate and implement strategies to support multiple leading clients for various regulatory activities. The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike. Key Responsibilities: ·       Provide strategic and tactical leadership of the regulatory affairs function in North America, in close collaboration with cross functional teams. ·       Lead client interactions and act as Subject Matter Expert on Regulatory projects for the biopharma clients. ·       Ensure compliance with all appropriate government regulations, industry guidelines, and best practices. ·       In collaboration with regulatory colleagues globally, devise and implement global regulatory strategy and provide leadership oversight for clients’ projects. ·       Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’ requirements. ·       Act as SME with deep knowledge of HA regulations for all aspects of biopharmaceutical regulations. ·       Collaborate with internal staff to author and compile documents for submission to regulatory agencies, including INDs, CTAs, BLAs, MAAs, and NDAs. ·       Mentor internal team across various regulatory projects. ·       Monitor Regulatory environment and communicate any changes and impact assessments to all team members. ·       Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization. ·       Hire, develop and mentor regulatory personnel and future regulatory staff. ·       Prepare client presentations & support department growth related activities, as needed. Experience & Qualifications : Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred. Eight or more years of experience in Regulatory Affairs for biopharmaceutical products (small & large molecule, drug-device combination, vaccines, etc.), experience with Phase 1 through Phase III products is highly desirable. Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track record of successful approvals. Direct experience working with the FDA and other health authorities. Experience with CBER and global biologics experience highly desired. Strong knowledge of the industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations. Must be able to assimilate and interpret trends in the life sciences regulatory environment that directly affect business decisions in the industry. Initiate and support development of digital technology solution for various processes across regulatory affairs/operations. Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details. Must be comfortable with ambiguity in a small, fast-paced environment. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-PB1 #Hybrid

Location: United States ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior Statistical Programmer to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Senior Statistical Programmer to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Main Job Tasks The Senior Statistical Programmer is a delivery-focused role responsible for leading and supporting aspects of the programming effort to deliver technical programming and information components of a project. The position requires strong technical skills, thorough knowledge of the industry, and demonstrated experience leading statistical programming activities and providing technical guidance to other programmers . The individual should be able to independently perform programming tasks, oversee programming deliverables, and effectively collaborate with cross-functional teams and external vendors. Responsibilities Programing for clinical trials: Program and validate derived datasets, tables, figures, listings. Process data from the external sources. Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations. Oversee programing work/deliverables from CROs. Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages. Electronic submissions: Program and validate CDISC compliant deliveries for the electronic submissions. Support in the creation of supporting documentation for submissions. Project Management: Ensure programming deliverables are on time and of high quality. Help managing internal contractors and external vendors. Standards and Guidelines: Participate in development of departmental working instructions and guidelines. Help in creation of enhanced functions/macros and utilities. Qualification & Experience Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline. BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry. Working knowledge of SAS and its various components. Knowledge of R programming in clinical trials Familiarity of the drug development process. Strong SAS and SAS Macro language skills. R programming skils in clinical trials Strong knowledge of industry standards. Ability to work on data integrations (ISS and ISE). Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #senior #permanent

Location: United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Main Job Tasks and Responsibilities: The Senior Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks Key Responsibilities: Responsible for supporting the Programming deliveries of a clinical study or project. Implements statistical programming aspects of the protocol and the clinical development program. Ensures high quality is built into own deliverables and the quality delivered by other programmers. Programs independently with high efficiency and quality. Writes and/or implements specifications and oversees completeness of relevant documentation. Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function. Ensures compliance with standards and automation usage. Plans and support team activities and tasks. Communicates and escalates risks within the assigned studies and/or projects. Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader. Education and Experience: Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience. Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology. Good understanding of the clinical drug development process. Strong communication skills and coordination skills. Current knowledge of technical and regulatory requirements relevant for the role Ability to proactively manage concurrent activities within a project Proficient ability to influence relevant stakeholders on programming-related items The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #senior#contract

Location: Pasig, Philippines Job Description: The Scientist/Senior Scientist – QPPV Office, Local Safety Support & Regulatory Intelligence is a safety expert who provides safety oversight, in their allocated region, for the Consumer portfolio of products throughout the life cycle of the products, including new product development. The incumbent works closely with and partners with the RMSO to proactively collaborate with regional colleagues in R&D, Regulatory, and Quality. The incumbent works closely alongside LPV country team leads in their region. The incumbent is a key contributor to regional safety deliverables and evaluations. The incumbent will provide backup to the RMSO and can represent the RMSO at meetings and for safety deliverables. Key Responsibilities: Safety evaluations and clinical insights contributing to the completion of the regional safety deliverables for the company portfolio. Identification, communication and management of potential and known safety risks. Cross-functional collaboration within and outside KMS. Ability to influence and work effectively with business partners and colleagues. A vocal and visible champion of safety insights as a key input into product development and post-market safety surveillance strategy. Work with RMSO (Regional Medical Safety Officer) to partner and align with regional cross-functional business partners and generate relevant safety assessments and reviews for their allocated region, for the Consumer portfolio of products, throughout the life cycle of the products, including new product development. Work closely with the RMSO and works collaboratively with others within KMS. Collaborates with the company's functional areas and LPV in their region. Job Competencies: Carry out structured problem-solving and Credo-based decision-making skills. Understand the clinical application of the technology/medication and assess the potential for a hazard to result in a harm. Critically evaluate safety data from multiple sources (post-market reports, literature, etc.), and communicate to align with GRASP (Global Risk Assessment Safety Physician) safety decisions. Work with diverse topics simultaneously. Provide assertive inputs on issues relating to patient/ consumer safety. Communicate effectively with cross-functional stakeholders. Job Complexities: Handle large data sets and draw objective conclusions using appropriate analyses. Collaborate with multiple functions and lines of business. Handle many products/product families simultaneously. Manage complex products. Meet timelines for deliverables according to SOPs. Experience and Qualifications: Licensed MD with at least 3 years of clinical experience Two or more years of industry experience in foundational to intermediate Pharmacovigilance . Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. Brings strong project management and organizational skills, with the ability to coordinate multiple safety-related activities, manage timelines and deliverables, represent the company in cross-functional meetings, and collaborate effectively with international teams across EMEA. Demonstrates the ability to critically assess PV data, identify clinically relevant patterns or trends, and translate safety findings into meaningful clinical insights. Possesses a good understanding of adverse events, serious adverse events, case assessment, safety signals, and benefit-risk considerations. Attention to detail; Diligence in record-keeping and records organization; Ability to manage high workload and critical issues; Computer-literate and proficient in MS Office applications. Team player; Displays initiative; Strong communication and presentation skills. Strong collaborative and interpersonal skills; Results-oriented and able to independently create and deliver; Ability to thrive in a global, cross-functional environment.

Location: United Kingdom ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Key Responsibilities Lead and provide statistical support for clinical studies. Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables Author and review key statistical documents, including: Statistical Analysis Plans (SAPs) Analysis Database Specifications (ADS) Statistical sections of clinical study reports Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory Provide guidance and oversight to statistical programmers as needed Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs Required Qualifications MS or PhD in Statistics, Biostatistics, or a related field There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous. Strong oral and written communication skills, with the ability to effectively communicate internally and with clients. Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations. Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #LI-Principal #Permanent

Location: United Kingdom ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Senior Statistician to to join our biometrics team. This is a full-time permanent opportunity with REMOTE. . Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Job Responsibilities Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Responsible for assuring that data for statistical analyses are complete, accurate, and consistent. Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions. Responsible for the validity of the analysis and exploring alternative analysis strategies as needed. Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation. Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings. Responsible for the statistical methods section of the reports. Identifies and corrects common flaws in the interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and ensures project-wide consistency. Effectively mentor peers with regard to statistical methodology and provide appropriate training to less experienced statisticians. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality. Requirements: MS or PhD in Statistics, Biostatistics, or related field.  PhD with 3-4 years of experience or MS with 5-7 years of experience. There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous. Strong oral and written communication skills, with the ability to effectively communicate internally and with clients. Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations. Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA. The Application Process Once you have submitted your CV, you will receive an acknowledgment that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below-industry-average turnover rates. ClinChoice is an equal-opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Senior#permanent

Location: United States ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career! Key Responsibilities Lead and provide statistical support for clinical studies, primarily within Oncology Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables Author and review key statistical documents, including: Statistical Analysis Plans (SAPs) Analysis Database Specifications (ADS) Statistical sections of clinical study reports Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory Provide guidance and oversight to statistical programmers as needed Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs Required Qualifications MS or PhD in Statistics, Biostatistics, or a related field Strong experience in Oncology studies Hands-on experience writing: Statistical Analysis Plans (SAPs) Analysis Database Specifications Reviewing and interpreting analysis results SAS programming skills required (hands-on or strong working knowledge) Excellent written and verbal communication skills Experience working in a CRO and/or pharmaceutical/biotech environment Preferred Qualifications Experience leading Phase II–III clinical trials Prior interaction with regulatory agencies Experience mentoring junior statisticians or programmers The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #LI-Principal #Permanent

Location: Yerevan, Armenia ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Scientist/Senior Scientist, QPPV Office on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Position Overview: The Scientist/Senior Scientist, QPPV Office, is a safety expert responsible for providing safety oversight within their allocated region for the Consumer portfolio of products throughout the product life cycle, including new product development. The role works closely with and partners with the RMSO to proactively collaborate with regional colleagues across R&D, Regulatory, and Quality. The Scientist/Senior Scientist also works closely with LPV country team leads within their region and serves as a key contributor to regional safety deliverables and evaluations. The role provides backup support to the RMSO and may represent the RMSO at meetings and in relation to safety deliverables. Main Job Tasks and Responsibilities: Safety evaluations and clinical insights contributing to the completion of the regional safety deliverables for the client's portfolio. o Identification, communication and management of potential and known safety risk o Cross-functional collaboration within and outside KMS o Ability to influence and work effectively with business partners and colleagues o A vocal and visible champion of safety insights as a key input into product development and post-market safety surveillance strategy Work with RMSO (Regional Medical Safety Officer) to partner and align with regional cross-functional business partners and generate relevant safety assessments and reviews for their allocated region, for the Consumer portfolio of products, throughout the life cycle of the products, including new product development. Work closely with the RMSO and works collaboratively with others within KMS. The Scientist/Senior Scientist, QPPV Office collaborates with members of client's functional areas and LPV in their region. Carry out structured problem-solving and Credo-based decision-making skills. Understand the clinical application of the technology/medication and assess the potential for a hazard to result in a harm. Critically evaluate safety data from multiple sources (post-market reports, literature, etc.), and communicate to align with GRASP (Global Risk Assessment Safety Physician) safety decisions. Work with diverse topics simultaneously Provide assertive inputs on issues relating to patient/ consumer safety. Communicate effectively with cross-functional stakeholders. Handle large data sets and draw objective conclusions using appropriate analyses. Collaborate with multiple functions and lines of business. Handle many products/product families simultaneously. Manage complex products. Meet timelines for deliverables according to SOPs. Education and Experience: Healthcare professional (e.g., MD, Pharm D, RN) with at least 3 years of clinical experience. MD is preferred. Two or more years of industry experience in medical safety is preferred. Ability to analyze, interpret and present complex data in a concise and understandable scientific manner, both orally and in written format, is essential. Attention to detail; Diligence in record-keeping and records organization; Ability to manage high workload and critical issues; Computer-literate and proficient in MS Office applications. Team player; Displays initiative; Strong communication and presentation skills. Strong collaborative and interpersonal skills; Results-oriented and able to independently create and deliver; Ability to thrive in a global, cross-functional environment. Our Benefits: Flexible Working Hours Full performance and development process with end of year reviews Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Location: Yerevan, Armenia ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Aggregate Reporting Physician on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Position Overview: The Senior Associate, Aggregate Reporting Physician position is responsible for developing, reviewing, and maintaining high-quality safety and pharmacovigilance documents that support the safety surveillance and regulatory compliance of consumer health products. It requires the ability to synthesize data from multiple sources, including individual case safety reports (ICSRs), aggregate safety data, clinical studies, epidemiological research, literature reviews, post-marketing surveillance, signal detection activities, and other safety data sources. The successful candidate will transform complex safety information into clear, concise, and scientifically accurate documents that support global pharmacovigilance activities and regulatory submissions and will work closely with Drug Safety, Medical Affairs, Regulatory Affairs, Clinical Development, Quality, and R&D teams to ensure consistent, evidence-based communication of product safety information. Main Job Tasks and Responsibilities: Prepare, review, and maintain pharmacovigilance and risk management documents for consumer health products. Synthesize safety information from multiple sources, including: Individual Case Safety Reports (ICSRs), Aggregate safety data analyses, Clinical trial safety data, Post-marketing surveillance data, Epidemiology studies, Published literature, Signal detection and evaluation activities, Benefit-risk assessments, Health Authority Assessment Reports. Draft and support the preparation of: Periodic Safety Update Reports (PSURs/PBRERs/PADERs), Ad Hoc Safety Reports, Development Safety Update Reports (DSURs), Signal assessment reports, Aggregate safety reports, Risk management documentation, Health authority responses, Safety narratives, Safety sections of regulatory submissions, Safety surveillance reports and presentations, Analysis and evaluation for the Safety Management Teams (SMT). Collaborate with Safety Scientists, Medical Reviewers and others to evaluate emerging safety information and communicate findings effectively. Assist in the interpretation of safety trends, potential signals, and benefit-risk considerations. Support literature surveillance activities and summarize relevant safety findings. Contribute to the development of safety conclusions and evidence-based recommendations. Support the preparation, review, and analysis of risk management activities and reports. Ensure all documents comply with global pharmacovigilance regulations, company SOPs, and applicable guidance documents. Maintain high standards of scientific accuracy, consistency, grammar, and document quality. Perform quality control reviews of safety documents and ensure timely delivery of assigned projects. Support inspection and audit readiness activities through accurate documentation practices. Education and Experience: Advanced degree required: PharmD, PhD, MD, MPH, MS, or equivalent scientific discipline. 3–6 years of experience in pharmacovigilance, drug safety, medical writing, regulatory writing, or related pharmaceutical, consumer health, or medical device industries. Experience preparing safety and pharmacovigilance documents preferred. Familiarity with global pharmacovigilance regulations and safety reporting requirements. Experience working in a matrixed environment with multiple stakeholders. Strong understanding of: Clinical research methodologies, Epidemiology and biostatistics, Evidence-based medicine, Regulatory and scientific communication requirements, Safety and benefit-risk assessment principles Expertise in literature evaluation and scientific data interpretation. Ability to critically analyze multiple complex scientific information and identify key insights to drive product safety. Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) with strong document formatting, data analysis, and presentation capabilities. Excellent medical writing, editing, and proofreading skills. Exceptional grammar, attention to detail, and document quality standards. Strong analytical and critical thinking capabilities. Effective project management and organizational skills Exceptional Communication and Presentation Skills, with the ability to convey complex clinical and scientific information clearly and effectively to diverse audiences. Ability to work independently while managing multiple priorities and deadlines. Our Benefits: Flexible Working Hours Full performance and development process with end of year reviews Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Location: United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Real World Data Programmer Consultant to join one of our clients. ClinChoice is a leading global CRO, dedicated to supporting clinical trials and real-world evidence research with a focus on exceptional quality, career development, and a supportive culture. As we expand our presence and offerings, we’re looking for an experienced Senior Real World Data Analytics Consultant to join our dynamic team and lead analytical efforts across diverse therapeutic areas for a high-profile sponsor. Position Overview: We are seeking a Senior Real World Data (RWD) Analytics Consultant/Senior Real World Data Programmer Consultant to lead and oversee complex statistical analyses, provide high-level strategic recommendations, and guide junior analysts in the execution of observational research. This leadership position combines technical expertise with client-facing responsibilities, allowing the successful candidate to influence key decisions within our client’s RWE and cross-functional teams. The Senior Consultant will be responsible for ensuring the highest standards of data analysis and driving innovations that enhance our client’s research outcomes. Key Responsibilities: Lead the development and execution of statistical analysis plans (SAPs) for large-scale real-world evidence (RWE) studies. Work directly with cross-functional teams and senior stakeholders to design data-driven solutions that meet sponsor needs. Oversee and mentor junior analysts, reviewing work for accuracy, quality, and consistency. Provide guidance on the development and optimization of RWD analytics workflows. Establish and maintain strong, trusted relationships with client counterparts. Act as a key advisor, offering strategic insights based on data findings, and helping guide decision-making processes. Lead the development of new tools and automated workflows to improve the efficiency and impact of RWD analysis. Drive the use of advanced analytics and machine learning to derive actionable insights from large, complex datasets. Lead the creation of sophisticated data visualizations, dashboards, and other reporting tools. Ensure that findings are effectively communicated to both technical and non-technical stakeholders. Drive the continuous improvement of data management, analysis methodologies, and reporting standards. Actively contribute to the development of best practices and standard operating procedures. Collaborate with internal teams (data scientists, epidemiologists, statisticians) and external stakeholders to integrate data from multiple sources and design innovative solutions. Qualifications: Experience: Minimum 4-5 years of experience in RWD analytics, biostatistics, epidemiology, or a related field, with at least 3 years in a leadership or consultancy role. Proven track record in managing complex observational research projects in the life sciences or healthcare sector, particularly with large health databases (claims data, EMR, etc.). Technical Skills: Expertise in SAS programming; advanced proficiency in SQL, R, Python, and other relevant programming languages (e.g., MATLAB, Hadoop, Spark). Experience working with cloud platforms like AWS, Azure, or Google Cloud is strongly preferred. Expertise in advanced data visualization tools such as Tableau, Power BI, or D3.js. Knowledge & Expertise: Deep understanding of the US healthcare system, health insurance claims data, and electronic medical records (EMR). Experience applying advanced statistical methods and machine learning techniques to large healthcare datasets. Familiarity with database management, data wrangling, and data integration techniques.. Education: Advanced degree (Master’s or PhD) in Biostatistics, Epidemiology, Data Science, Computer Science, or a related field. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #LI-Senior #Contract

Location: United States Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is searching for a Clinical R Data Scientist Consultant to join one of our clients. We are seeking a Clinical R Data Scientist Consultant with strong experience in R and a solid background in clinical programming . The ideal candidate will have hands-on experience developing SDTM and ADAM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams. Key Responsibilities Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards. Support TLF (Tables, Listings, Figures) generation in R or SAS as needed. Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting. Collaborate with statisticians, data managers, and clinical teams to understand programming requirements. Perform QC checks , reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA). Contribute to programming workflows, documentation, and version control best practices. Support automation initiatives and R-based pipeline development. Utilize SAS for legacy studies or where SAS support is required. Required Qualifications Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. 2-3+ years of experience in clinical programming , with a strong focus on R. Proven experience in creating SDTM and ADaM datasets using R. Working knowledge of SAS programming . Solid understanding of CDISC standards (SDTM, ADaM). Experience with clinical trial data, regulatory submissions, and QC processes. Strong analytical, problem-solving, and documentation skills. Required Qualifications Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC) , or other clinical programming toolkits. Understanding of R Markdown, Shiny apps, or reproducible reporting tools. Exposure to GxP validation, version control (Git), and automated workflows. Experience working in a CRO or pharmaceutical environment. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our low industry-average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #LI-Senior #Contract

Location: Cincinnati, Ohio, United States ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior Associate, Regulatory Affairs (ONSITE) on a permanent basis at Cincinnati, OH . Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! J ob Title: Senior Associate, Regulatory Affairs Employment Type: Full Time Location: Hybrid (Cincinnati, Ohio) - Location Address: 4545 Creek Rd Blue Ash, OH 45242 Responsible for managing, planning, preparation, and delivery of documents both electronic- and paper-based in support of assigned. global regulatory product registrations, renewals, tenders/customs, etc. Coordinate the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval. Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions. Submit and manage applications for the US FDA Certificates to Foreign Government (CFGs). Maintain various tracking tools to ensure up-to-date information and traceability of all regulatory data/documentation. Perform and/or coordinate legalization, notarization, and apostille of regulatory documents Ensure compliance with current good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping. Assist all regions in answering inquiries and providing required documents and information utilizing various search tools and systems. Perform document filing and retrieval functions as directed and per company’s policies and procedures. Effectively communicate with internal and external teams and/or clients as to the status of deliverables, to ensure timely and satisfactory completion of tasks and expectations. Communicate with the project teams on a regular basis regarding regulatory updates. Provide support to internal and external teams to address various technical inquiries and provide requested data/information Participate in group meetings and provide tactical approaches to addressing issues of basic complexity Perform other tasks as assigned. Experience/Skills Bachelor’s degree (Life Sciences or a regulatory related field preferred) Minimum of 1 year of hands-on experience in medical device regulatory affairs, or at least 3 years of combined regulatory affairs and related experience. Basic knowledge of US FDA QSR, ISO 13485, EU MDD/MDR. Knowledge of global medical devices registration process is a plus Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint) Have a good understanding of current Good Documentation Practices in a regulatory environment. Self-starter with the ability to work in a team environment and on projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision. Excellent organizational skills with strong attention to detail, effective planning, and the ability to multitask efficiently Must possess excellent written and verbal communication skills. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-PB1 #Hybrid

Location: Pasig City, Philippines JOB DESCRIPTION Summary: The ERP System Operations Project Manager leads the international arm of ClinChoice’s Global ERP Administration function and collaborates with the company’s international cross-functional teams to support users in their day-to-day use of Microsoft Dynamics 365. The role also works with the company’s ERP development team and third-party vendor to maintain and optimize ERP system operations. Responsibilities: Lead the International ERP Administration team and oversee first-level technical and functional support for international users of Microsoft Dynamics 365 modules. Collaborate closely with international cross-functional teams across multiple entities and with key ERP stakeholders to diagnose system issues, recommend solutions, and continuously identify opportunities to improve ERP performance. Analyze business requirements; prepare functional specifications and design documentation; and manage change requests, service requests, and budget alignment and Manage the full system project lifecycle, including project kickoff, planning, issue tracking, timeline management, and testing coordination. Oversee testing activities and release schedules to ensure the successful delivery of system enhancements. Manage ERP timesheet operations and support resource planning. Monitor company-wide timesheet and resource-planning processes to ensure satisfactory monthly completion and approval rates. Continuously evaluate and optimize timesheet-management processes and training programs. Manage ERP user permissions and oversee the development, maintenance, and review of system-related standard operating procedures. Manage the tracking and prioritization of open requests, ensuring the timely resolution of critical system issues. Lead and facilitate ERP project meetings with stakeholders at all organizational levels. Design, develop, and deliver company-wide application training programs, including monthly ERP timesheet training for new hires, line managers, and project functional leads. Evaluate, initiate, and lead cross-functional standardization and automation initiatives that drive continuous business process improvement and operational efficiency. Skills and Qualifications: Bachelor’s degree or higher in information systems, computer science, accounting, finance, or a related field. Minimum of 5 years of experience in ERP operations or finance systems support . Hands-on experience with Microsoft Dynamics 365 is highly preferred . Strong written and verbal communication skills, with excellent analytical and problem-solving abilities. Proven ability to lead cross-functional initiatives and manage multiple projects simultaneously. Experience managing system implementation, maintenance, and continuous improvement initiatives. Advanced proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook. Ability to work effectively as a collaborative team member and support operations across multiple time zones. Business-level proficiency in English is required , and proficiency in Mandarin Chinese is preferred for daily collaboration with the ERP vendor and the China IT team, along with availability across time zones during the financial close period. Flexibility to support U.S. and European time zones.