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Location: Pasig City, Philippines Job Description: Help guide report strategy, help determine important safety concerns and review medical and medical safety content that will be included or discussed in the report, including but not limited to safety signals, health authority requests, safety-related literature, adverse event case reviews, benefit-risk assessments, and overall medical assessments and conclusions. Work in collaboration with contributing team members, particularly with the reports assigned to the Global Risk Assessment and Safety Physician. Review all stages of the report that are assigned during the report authoring process, record their recommended revisions, and indicate completion of their reviews in the corresponding systems. Key Responsibilities: Provide medical and scientific judgment in the evaluation of data pertaining to the efficacy and safety of Client products including, but not limited to, PBRER-PSURs and benefit-risk evaluations Review and contribute to strategy discussions, including determination of the important safety concerns and review of draft/final data, HA feedback topics, signals, and benefit-risk evaluation. Coordinate with Global Risk Assessment and Safety Physicians regarding PBRER steps and hand-offs and collaborate with other members of the report authoring team. Review the drafts and final reports as assigned and provide feedback, which may include pre-initial, drafts, drafts, final drafts, and final reports as assigned. Qualifications: Requirement: Licensed Medical Physician Experience in Drug Safety and Pharmacovigilance (PV) Concepts, regulatory requirements, research principles, and safety data analysis. 1-3 years of experience in pharmaceutical regulations and R&D processes. Technical Skills: the 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 proficiency in MS Office applications. Internal and external networking skills: strong collaborative and interpersonal skills, results-oriented and ability to independently create and deliver, ability to thrive in a global, cross-functional environment. Data entry experience desired. Accountability for delivery of results. Decision making and problem-solving skills. Proactive approach/uses own initiative. Manages own work, able to prioritize, plan and organize work assignments and work under strict timelines Ability to follow guidelines, working practices etc. Experience of working with SOP/WI preferred

Location: United States Job Description – Medical Writer / Medical Reviewer (Ovarian Cancer Oncology Expertise) Position Title Medical Writer / Medical Reviewer – Oncology (Ovarian Cancer) Location Remote / Hybrid Position Summary We are seeking an experienced Medical Writer or Medical Reviewer with expertise in Ovarian Cancer and Gynecologic Oncology to support the development, review, and delivery of high-quality scientific and medical content. The successful candidate will collaborate with Medical Affairs, Clinical Development, Regulatory Affairs, Biostatistics, and external experts to ensure scientific accuracy, compliance, and timely execution of deliverables. The role requires a strong understanding of ovarian cancer biology, treatment landscape, clinical trial data, and publication practices. Key Responsibilities Medical Writing Develop and review scientific and medical materials, including: Clinical study reports (CSRs) Protocols and amendments Investigator brochures Manuscripts, abstracts, and posters Slide decks and educational materials Medical information responses and FAQs Congress presentations and publication plans Summarize and interpret clinical data related to ovarian cancer therapies and biomarkers. Ensure consistency with ICH, GCP, GPP, and company standards. Conduct literature reviews and evidence synthesis from peer-reviewed journals and congress proceedings. Collaborate with cross-functional teams to support regulatory submissions and medical affairs activities. Medical Review Perform scientific and medical review of promotional and non-promotional materials. Verify scientific accuracy, consistency, and compliance with regulatory requirements. Review clinical data, references, and claims for accuracy and balance. Support MLR (Medical-Legal-Regulatory) review processes. Provide expert input regarding ovarian cancer treatment guidelines and emerging therapies. Scientific Expertise Maintain current knowledge of: Epithelial ovarian cancer Platinum-sensitive and platinum-resistant disease BRCA and HRD biomarkers PARP inhibitors Antibody-drug conjugates Immuno-oncology approaches NCCN, ESMO, and ASCO treatment guidelines Monitor publications, clinical trials, and congress updates (ASCO, ESGO, SGO, ESMO). Required Qualifications Education MD, PharmD, PhD, or Master's degree in Life Sciences, Oncology, Pharmacy, or related field. Advanced degree preferred. Experience 3–8+ years of medical writing or medical review experience in pharmaceutical, biotechnology, CRO, or medical communications environments. Demonstrated expertise in Oncology , with significant experience in Ovarian Cancer . Experience with clinical development, publications, and medical affairs deliverables. Familiarity with ICH, GCP, GPP, FDA, EMA, and international regulatory requirements. Preferred Qualifications Experience supporting ovarian cancer assets or clinical trials. Knowledge of biomarker-driven therapies and companion diagnostics. Publication experience (manuscripts, abstracts, posters). Experience participating in MLR review processes. Familiarity with EndNote, PubMed, Veeva Vault, and reference management tools.

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 Immunology or any therapeutic areas 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: Remote, United States ClinChoice a global CRO is recruiting for a Business Development Director to join our internal commercial team in the U.S. As a Business Development Director, you will focus on driving full clinical operations service growth by securing new clients and expanding services in existing clients to drive revenue growth. You will be responsible for the full sales lifecycle – from prospecting, developing relationship, to closing all deals including complex, high value deals. Previous experience working with a global Contract Research Organization and selling full clinical operations services is required. Experience with developing clients with outsourcing exposure to China is a plus. This is a full-time, permanent opportunity based in the US. Candidates based on the West Coast are preferred, though applicants from other locations may also be considered based on their CRO experience. Main Job Tasks and Responsibilities Sales strategy and execution : Identify, assess, and develop new global full clinical service strategic plans. Implement realistic and actionable plans to achieve or exceed annual revenue goals that align with the company’s growth objective. Prospecting: Actively identify and secure new business opportunities and/or grow/expand services with existing clients. Relationship Management: Build and maintain positive relationships and provide regular face time with key decision makers within prospect and client organizations, including their Clinical Operations function, Outsourcing function, Procurement function, and C-Suite executives. Market Intelligence: Represent Company at key conferences, trade shows, and networking events to learn and monitor industry trends and competitor activities. CRM Management: Maintain all pipeline data promptly from prospecting to closing contracts in company CRM database. Education, Experience and Skills 10+ years of sales or business development experience, with at least 6 years in global full service CROs. Established a network of decision-makers in the life-sciences industry. Experience selling to, presenting to, and building relationships with senior management and C-level stakeholders. Strong negotiation skills with a proven track record of closing complex, multi-million-dollar business deals Persuasive and compelling presentation and communication skills, both written and verbal Ability to understand internal business need, interpret business challenges and present quick and responsive high-level solutions. Deadline-driven with a proven ability to manage multiple engagements at varying points in the sales cycle. Bachelor’s degree in Life Science, Biotechnology, or Business Administration; MBA is a plus. 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 30 years of proven high-quality delivery and results across all our services with over 3,000 professionals in more than 20 countries across US, EU, APAC and ANZ. 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. 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. Keywords: Director of Business Development, business development, marketing, contracting, travel, clinical trials, CRO, Clinical Research Organization, clinical development, CRO management, relationship management, clinical research sales, account management, CRO full-service sales, Bid Defense, contract negotiations, business to business sales #LI-VH1 #LI-Remote #LI-Director #LI-FULLTIME

Location: Brazil 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 Associate 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. Job Title ANALYST REGULATORY AFFAIRS Consultant Job Summary Ensures proper submission and approvals for market licenses including new registrations, changes and timely renewals, and establishment registrations, organizing and balancing a multitude of projects simultaneously. Scope Major  Roles and Responsibilities Elaborate regulatory strategy and execute submission of changes, new registrations and renewals in timely manner with some guidance. Execute activities to obtain or update establishment registration licenses. Execute post-approval activities such as preparation of communications to stakeholders, labels and Instructions for Use and system updates. Request and follow-up of documentation to prepare registration dossiers. Supports regional team on product submissions schedules, prioritization, and pipeline management. Support internal and external audits with documentation requests. Interacts with other stakeholders, government agencies in a professional, decisive, & articulate manner. Act as a point of contact for stakeholders to support business plans and regulatory needs. Review labels compliance in internal system. ·       Support projects as representative of the subject/country. ·       Elaborate procedures of the area. ·       Organize team meetings and elaborate agenda and minutes. ·       Manage quality issues. ·       Manage compulsory certification (INMETRO) and GMP activities. Competencies Knowledge of Local & International Regulation and Processes Analytical capability and investigative skills Self-motivated and committed to a team approach Communicates clearly and effectively. Prioritizes work to meet deadlines Planning and Organizing skills Understands the importance of the adherence to compliance Project Management skills and ability to manage complex data with excel spreadsheets are desirable GLP Behaviors Collaboration and teaming Results & Performance Driven Sense of Urgency Integrity & Credo-based Actions Intellectual curiosity Self Awareness & Adaptability Experience/ Qualification  Requirements Must have 1-2 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for Brazilian Health Authorities and a successful track record. Desirable experience in Medical Devices or Pharma background. Education Requirements ·       A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Advanced reading and writing Skills in English are required; intermediate to advanced speaking is desirable. Fluent in Portuguese.

Location: Mexico re 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 Associate 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. Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios Location / Ubicación: Ciudad de México, México Position Summary / Resumen del puesto: Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations. Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios. Key responsabilities / Responsabilidades principales: Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones). Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS). Apoyar en la interpretación de normativas locales e internacionales. Apoyar la coordinación de solicitudes y actividades con áreas internas. Mantener actualizados archivos regulatorios y bases de datos. Qualifications / Requisitos: Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field. Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín. Experience / Experiencia: Minimum 1 year of experience in regulatory affairs, quality or medical device industry. Technical skills / Conocimientos técnicos: Mexican medical device regulations (COFEPRIS). Medical device classification. NOMs and standards aplicable. Intermediate-advanced English (technical reading required). Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting). Core competencies / competencias clave: Attention to detail. Organizational and documentation skills. Effective communication. Team collaboration Learning Agility.

Location: Brazil 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 an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients. The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners . 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: Safety and PV System Management Perform the quality check of the PV cases and ensure that the English translation has been properly performed. Keep up to date a local tracker of the individual safety reports. Be the subject matter expert at local level on the case management activities. Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams. Establish and maintain local indicators on the compliance of the safety reports submission. Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings. Perform regulatory monitoring for impact on vigilance activities and responsibilities. Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). Maintain oversight of proper identification of local literature articles for AE reporting as required. Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable. Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals. Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements. Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs. Perform other agreed tasks assigned by manager Perform document management and archiving as required Procedural Document Ensure current knowledge of all relevant company procedures and training. Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements. Audit & Inspection readiness Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable PV contract management Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information Business Continuity Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage) Education and Experience: Education: health care science professional or equivalent training Significant training in data management with strong IT skills. 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…). Fluent in English. French as a mother tongue. Excellent communication skills and ability to work with cross-functional teams. Rigor is a key skill for this mission. 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. Key words: Area Safety Officer, Local Safety Officer, PV, QC, CAPA,QPPV #LI-PB1

Location: Czech Republic 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 Labeling Artwork Controller - Consultant in Czech Republic for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock meetings to ensure stakeholder alignment. Manage Veraciti system-related issues and escalate appropriately. Suggest and implement technology solutions for artwork and labeling processes. Create, update, and maintain training documentation for systems and processes. Supervise Artwork Controllers to ensure task completion and provide support during peak periods. Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. Track and follow up on action items from cross-functional meetings. Communicate project status, risks, and milestones consistently to stakeholders. Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. Conduct design-to-press color management assessments and feasibility consultations. Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. Address process and executional quality issues; support system and process improvements. Manage ad-hoc artwork-related requests and cascade process/system communications. Qualifications & Experience: Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. Strong knowledge of global regulatory requirements for product labeling and packaging. Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. Six Sigma Green Belt certification or equivalent experience in continuous improvement. Excellent communication, problem-solving, and organizational skills. PMP certification or formal project management training is 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 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. Keywords : Regulatory Affairs, Labeling, Artwork, packaging, consumer products #LI-PR1 #LI-REMOTE #Manager #Contract

Location: Italy 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 Labeling Artwork Controller - Consultant in Italy for 12 months Contract with REMOTE option with possibility of extension to join one of our consumer product clients. Role Summary The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross-functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision. Key Responsibilities: Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. Drive process improvements related to artwork development, approval workflows, and digital tools. Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. Maintain artwork issue logs and attend escalation meetings to provide updates. Identify inefficiencies and escalate to Hub Leads when required. Participate in content lock meetings to ensure stakeholder alignment. Manage Veraciti system-related issues and escalate appropriately. Suggest and implement technology solutions for artwork and labeling processes. Create, update, and maintain training documentation for systems and processes. Supervise Artwork Controllers to ensure task completion and provide support during peak periods. Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. Track and follow up on action items from cross-functional meetings. Communicate project status, risks, and milestones consistently to stakeholders. Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives. Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. Conduct design-to-press color management assessments and feasibility consultations. Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. Address process and executional quality issues; support system and process improvements. Manage ad-hoc artwork-related requests and cascade process/system communications. Qualifications & Experience: Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. Strong knowledge of global regulatory requirements for product labeling and packaging. Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. Six Sigma Green Belt certification or equivalent experience in continuous improvement. Excellent communication, problem-solving, and organizational skills. PMP certification or formal project management training is 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 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. Keywords : Regulatory Affairs, Labeling, Artwork, packaging, consumer products #LI-PR1 #LI-REMOTE #Manager #Contract

Location: Pasig City, Philippines Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities such as implementation of quality control process. Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries. Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate. Maintain PV expertise and understanding of international safety regulations and guidelines. Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines. Provide timely feedback to case processors on the errors/ discrepancies noted. Assist in training/mentoring of other case processing/medical review personnel as necessitated. Adapt to different client case processing conventions and multi-task as per business needs. Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement. Participate in organizational activities to meet objectives suitable for the role/area of expertise. Candidate Profile: Medical Physician with at least 2 years of experience as Medical Reviewer for ICSRs. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skills (GVP concepts & medical aspects such as disease condition, product portfolio etc). Must have hands-on experience with MS Office applications (Outlook, Excel, Word, Power Point etc).

Location: Pasig City, Philippines Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines. Minimum of 4+ years of clinical programming experience, along with 1+ year of project management and 1+ year of people management experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understanding of clinical drug development process. Strong communication skills and coordination skills. ability to communicate with global teams with supervision. Good understanding of clinical drug development process. Detail-oriented and ability to learn and adapt to changes.

Location: Brazil Job Description Job Title: Medical Reviewer Employment Type: Contract Location: Brazil Experience – 2 to 5 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centres and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities such as implementation of quality control process. Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries. Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate. Maintain PV expertise, and understanding of international safety regulations and guidelines. Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines. Provide timely feedback to case processors on the errors/ discrepancies noted. Assist in training/mentoring of other case processing/medical review personnel as necessitated. Adapt to different client case processing conventions and multi-task as per business needs. Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement. Participate in organizational activities to meet objectives suitable for the role/area of expertise. Candidate Profile: Should be a MBBS/MD with at least 2 years of experience as Medical Reviewer for ICSRs. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (GVP concepts & medical aspects such as disease condition, product portfolio etc) Must have hands on experience with MS Office applications (Outlook, Excel, Word, Power Point etc) Must be able to Write and speak Japanese. Dynamic working hours.

Location: Brazil Job Description Job Title: Senior Executive / Specialist - Case Processing E mployment Type: Contract Location: Brazil (Remote) A bout ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database. Experience in ARGUS database. Experience in rare disease portfolio. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (ICSR, Safety database etc.). Candidate Profile: Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements. Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream. Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.). Must be able to Write and speak Japanese. Dynamic working hours.