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    Expert Medical Regulatory Writer

    Sanofi
    8+ years
    Not Disclosed
    Hyderabad
    10 Dec. 13, 2024
    Job Description
    Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Medical Regulatory Writer
    Location: India (Sanofi Global Hub)
    Travel: As per business needs
    Job Type: Permanent, Full-time

    About Sanofi Global Hub

    Sanofi Global Hub is a central resource organization set up to streamline processes across various departments such as Specialty Care, Vaccines, General Medicines, R&D, Data & Digital, and more. Based in India, the hub supports global teams by centralizing activities to enhance efficiencies and reduce reliance on external service providers. It works closely with Medical, HEVA, and Commercial teams to support Sanofi’s global operations.

    Main Responsibilities

    As a Senior Medical Regulatory Writer, you will be responsible for leading the writing and editing of high-quality clinical and safety documents, supporting regulatory submissions to health authorities globally. Your primary responsibilities will include:

    Document Creation and Editing:

    • Lead the creation of complex clinical documents such as Clinical Study Reports (CSR), Clinical Trial Dossier (CTD) submission documents (including clinical overviews, safety summaries, efficacy summaries, clinical pharmacology reports), Risk Management Plans (RMP), Periodic Benefit-Risk Evaluation Reports (PBRER), immunogenicity reports, and other key regulatory documents.
    • Provide expert content guidance and high-quality medical writing for submission to regulatory authorities, ensuring compliance with internal and external standards.
    • Work as a subject matter expert (SME) and mentor for medical and senior medical writers, providing peer reviews and scientific input.

    Collaboration and Leadership:

    • Participate in cross-functional teams such as Clinical Trial Teams (CTT), Clinical Submission Teams (CST), Global Clinical Teams (GCT), and Safety Management Teams (SMT) to ensure alignment and smooth regulatory submissions.
    • Develop and maintain therapeutic area (TA) expertise to effectively support medical regulatory content development and provide advocacy to other departments.
    • Provide strategic input on medical regulatory needs and support the development of new writers.

    Regulatory Writing and Strategy:

    • Lead and deliver high-quality medical documents, ensuring the timeliness and compliance with regulatory requirements.
    • Support the planning and analysis for the presentation of data in clinical trials.
    • Collaborate closely with global and local teams to identify medical writing needs and prepare customized deliverables.
    • Assist in the development of strategies and plans for regulatory submissions, and work with vendors as needed for document preparation.

    Stakeholder Interaction:

    • Maintain strong relationships with stakeholders across medical, clinical, pharmacovigilance, biostatistics, regulatory, and legal teams to ensure efficient document delivery and compliance.
    • Act as a liaison between different departments to ensure the proper communication and understanding of regulatory requirements.

    About You

    Experience & Skills:

    • ≥8 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
    • Expertise in global registration of drugs, with a solid understanding of ICH-GCP guidelines and regulatory requirements.
    • Ability to write complex documents and manage multiple projects simultaneously.
    • Proven experience in working independently while also leading project teams.

    Soft Skills:

    • Strong stakeholder management and communication skills.
    • Ability to work independently and collaboratively in a team.
    • Leadership skills with the ability to mentor junior writers and guide team efforts.

    Technical Skills:

    • Expertise in global regulatory submissions and clinical writing for marketing authorization, renewals, and maintenance activities.
    • In-depth knowledge of therapeutic areas and regulatory writing needs across different domains.
    • Skilled in project management and able to work efficiently across multiple teams.

    Education:

    • Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Masters, or Bachelor’s degree in science, Pharm D, or medical degree like MBBS, BDS, MD).

    Languages:

    • Fluent in English, both written and spoken.

    Why Sanofi?

    At Sanofi, we aim for progress and excellence in healthcare. We offer an inclusive, collaborative, and dynamic work environment where you can contribute to meaningful innovations in medicine. Join us as we pursue extraordinary progress and make a significant impact in the healthcare industry.

    Equal Opportunity Employer:
    Sanofi is committed to providing equal opportunities to all employees, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

    Pursue Progress. Discover Extraordinary.
    Become part of Sanofi’s journey to make miracles happen.

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