20 Regulatory Writing Jobs

Responsibilities: Compilation and review of regulatory dossiers (CTD, ACTD, eCTD) for CIS, LATAM (especially Brazil & Mexico), African, and EU regions. Handle full lifecycle of product registration including new submissions, renewals. Review technical documentation: PDR, DMF, AMV, BMR/BPR, Specifications, Stability Reports, BE Studies, etc. Address Ministry of Health (MoH) queries and manage deficiency responses. Manage post-approval changes and variation submissions. Liaise with international regulatory agents and distributors for submission coordination. Artwork review and approval ensuring compliance with label regulations. Maintain up-to-date registration database and submission tracker....

Client discovery, scoping, and requirements (business?side) Lead requirements elicitation with client Medical Writing/Regulatory teams for CSR authoring (template standards, TA nuances, target sections, review cadence, acceptance criteria, quality bars). Translate business goals (timelines, submission strategy, risk tolerance, review workflows) into clear deliverables and negotiate scope, timelines, and costs; manage change requests and approvals. Define done for each CSR section (e.g., Safety Evaluation, Efficacy) including scientific tone, numerical consistency, and ICH E3 alignment; maintain a living Requirements & Assumptions log Translation to technical work (internal hand?off) Soft Ski...

As a Medical Writer, you will be responsible for preparing, reviewing, and editing reports, manuscripts, drug monographs, medico-marketing material, systematic reviews, and meta-analysis on varied disease domains. Additionally, you will handle projects in regulatory writing, including protocols, clinical study reports, patient consent forms, case report forms, and other related activities. Key Responsibilities: - Prepare and review reports on disease background, epidemiology, outcomes, and disease burden in oncology and non-oncology domains - Conduct literature survey/searches for HEOR/RWE studies and other published literature from electronic databases - Prepare documents for value communic...

Role Overview: As a Senior Medical Writer at Bengaluru Luxor North Tower, you will work largely independently on assignments or for complex documents under the guidance of a mentor. Your role involves facilitating the delivery of written assignments through proactive coordination of stakeholders to build content. You are expected to have a strong understanding of clinical trials design and interpretation of statistically analyzed clinical research data. It is crucial for you to drive and coordinate the process to draft, review, and approve written assignments while meeting the quality standards of the global organization. Working in complex matrix organizations is an essential part of your r...

You will be responsible for the following key tasks: - Develop, write, and edit various scientific manuscripts, review articles, case studies, and conference abstracts/posters. - Prepare regulatory and clinical documents such as clinical study reports, investigator brochures, patient information leaflets, and regulatory dossiers. - Create medical communication materials including slide decks, CME content, and white papers tailored for healthcare professionals. - Collaborate effectively with researchers, clinicians, and regulatory teams to ensure accuracy, consistency, and compliance with journal/regulatory requirements. - Conduct thorough literature reviews and ensure precise referencing usi...

Develop and review content for various regulatory documents; ensure quality as per set regulatory standards and compliance requirement. Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. Authoring of protocols, CSRs, IBs, ICFs, Lay Summaries and other Module 2 documents SKILLS: Good communication skills (Written and Oral) MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Conse...

As a member of the Global Health Economics & Outcomes Research (HEOR) team at our company, your role will involve developing and updating Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers, and early HTA briefing books across multiple therapeutic areas. You will also contribute to HEOR publication execution by developing abstracts, posters, and manuscripts while assisting in the creation of training materials and onboarding documents for HEOR writing resources. It is essential for you to adhere to internal processes and ensure compliance with publication and HTA standards. Key Responsibilities: - Develop and update Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers,...

As a Global HEOR Value Writing Senior Associate in the Global Health Economics & Outcomes Research (HEOR) department, your role involves developing and updating Global Value Dossiers (GVDs), US AMCP dossiers, EU JCA dossiers, and early HTA briefing books across multiple therapeutic areas as assigned by the team lead. You will also contribute to HEOR publication execution by developing abstracts, posters, and manuscripts. Additionally, you will assist in creating training materials and onboarding documents for HEOR writing resources. It is essential to adhere to internal processes and ensure compliance with publication and HTA standards. You will be responsible for reviewing and QC work of pe...

We are seeking an experienced and detail-oriented Medical Reviewer to join our team. The role involves reviewing, analyzing, and ensuring accuracy, consistency, and compliance of medical and scientific content in alignment with regulatory, clinical, and organizational standards. Key Responsibilities Review medical, clinical, and regulatory documents for scientific accuracy, clarity, grammar, and compliance. Ensure consistency of terminology, data, and style across all documents. Validate clinical and safety data in reports and submissions against source documents. Collaborate with cross-functional teams including medical writers, clinical research, and regulatory affairs. Provide feedback an...

As a Lead, Clinical Regulatory Writing & AI Solutions at Asthra AI, you will play a pivotal role in revolutionizing the pharmaceutical industry by leveraging AI-driven automation for regulatory documents. Your expertise in drafting clinical trial-related documents such as protocols, CSRs, and Investigator Brochures (IB) will be instrumental in shaping the future of clinical regulatory writing. Your key responsibilities will include creating and refining templates for essential clinical trial documents, ensuring alignment with industry standards. You will also be responsible for developing and enhancing prompts for AI-driven document automation, guaranteeing compliance with regulatory require...

Qualification: M.Sc. / M.Pharm / Ph.D. in Life Sciences, Biomedical Sciences, Biotechnology, or a related field Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist with strong experience in medical and clinical writing, focused on regulatory compliance under EU IVDR. The ideal candidate will have hands-on expertise in authoring key performance evaluation documents and supporting the preparation and maintenance of Technical Documentation (TD) for CE marking of IVD products. In addition to EU IVDR compliance, the candidate will support global product registration efforts , including preparation of regulatory documentation for submission in multiple markets. The role requ...

As a Medical and Pharmaceutical Content Writer at [Company Name], you will play a crucial role in crafting compelling and informative content across various platforms, including websites, blogs, scientific publications, and marketing materials. You will collaborate with subject matter experts and researchers to translate complex medical and pharmaceutical concepts into accessible, reader-friendly content. Key Responsibilities: Content Creation: Develop and write a wide range of medical and pharmaceutical content, including but not limited to: Scientific articles Blog posts Whitepapers Research summaries Patient education materials Marketing collateral Research: Conduct in-depth research on m...

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specificati...

RRD GO Creative is seeking experienced Medical Writers to join our team in Chennai. In this role, you will play a crucial part in developing high-quality and scientifically accurate medical and regulatory documents, such as clinical study reports, protocols, and brochures. Your responsibilities will also include creating clear and concise medical content tailored for healthcare professionals, regulatory agencies, and internal stakeholders. To excel in this role, you must conduct thorough research and literature reviews to ensure content accuracy and compliance with industry standards. Collaborating with subject matter experts, scientists, and regulatory teams is essential to develop compelli...

The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the deli...

Minimum Qualification Requirements: Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing(CSR/Protocol writing/IB) Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and c...

What you will do In this vital role you will serve as the operational head for a team of Global HEOR Value Writers (L5) supporting Amgens global market access and reimbursement. This role is accountable for ensuring the timely and high-quality development of payer- and HTA-relevant deliverables including Global Value Dossiers (GVDs), AMCP dossiers, early HTA briefing books, reports and scientific publications across multiple therapeutic areas. The Global HEOR Value Writing Leader aligns closely with the Global Head HTA Strategy & Project Management and the Global HEOR Product Leads on plans and timelines for the relevant deliverables. Lead, handle, and mentor a team of Global HEOR Value Writ...

Hi Hiring for the leading ITES Company for Regulatory Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the informatio...

Job Overview In the role of Pharmaceutical Medical Writer, you will have the opportunity to work closely with other writers, project managers and support specialists to produce a wide variety of regulatory and scientific reports, plans, and other written deliverables for pharma/biotech clients. Roles and Responsibilities As a member of our project writing team, you will be responsible for producing assigned written documents and reports to a high standard. Your specific responsibilities include: Primary responsibility for developing and delivering accurate, high-quality scientific content within the project specifications, timeline, and budget Interacting regularly with clients, project mana...