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    Expert Medical Regulatory Writer

    Sanofi
    8+ years
    Not Disclosed
    Hyderabad
    10 Feb. 17, 2025
    Job Description
    Job Type: Full Time Education: MBBS/BDS/BAMS/BHMS/MD/PhD/D Pharma/Pharm D 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

    Expert Medical Regulatory Writer

    Location: Hyderabad, India
    Job Type: Permanent
    Posted on: February 06, 2025
    Closing on: April 30, 2025

    Main Responsibilities:

    • Write and/or edit high-quality clinical and safety documents for regulatory submissions, including complex Clinical Study Reports (CSR), CTD submission documents (clinical overview [CO], summary of clinical efficacy [SCE], clinical safety [SCS], clinical pharmacology [SCP], and biopharmaceutics [SBP]), Periodic Benefit-Risk Evaluation Report (PBRER), addendum to clinical overview (ACO), Risk Management Plans (RMP), Product and Disease ID Cards, clinical evaluation reports, briefing packages, health authority responses, immunogenicity reports, product alerts, and trial transparency documents.
    • Deliver high-quality medical documents on time and in compliance with internal and external standards.
    • Work independently on documents, acting as a subject matter expert (SME) on clinical deliverables.
    • Mentor junior and senior medical writers, providing scientific input and peer reviews.

    Essential Job Duties and Responsibilities:

    1. Lead complex submissions, contribute to key messaging meetings, and provide expert content guidance for CTD medical sections.
    2. Participate in planning data analysis and presentation, serving as an ad-hoc member of the Clinical Trial Team (CTT), a core member of the Clinical Submission Teams (CST), and an extended member of the Global Clinical Teams (GCT) and Safety Management Team (SMT).
    3. Develop and maintain therapeutic area (TA) expertise and advocate for document-related initiatives across functions.
    4. Review peer-created content, act as a mentor, and train writers on new document types.
    5. Work with minimal supervision and support the development of medical regulatory writers.
    6. Adapt knowledge to work across multiple therapeutic areas.

    Collaboration:

    • Work closely with global and local scientific communication teams, medical regulatory writing teams, pharmacovigilance teams, CTT, CST, GCT, and SMT.

    People Responsibilities:

    1. Maintain strong relationships with stakeholders within the global business unit and product teams.
    2. Interact effectively with medical and pharmacovigilance departments.
    3. Assist other medical regulatory writers in knowledge sharing and skill development.

    Performance Expectations:

    1. Deliver documents (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, clinical evaluation report, briefing packages, HAQs, immunogenicity reports) within agreed timelines and quality standards.
    2. Maintain an understanding of product alerts and trial transparency documents, adapting quickly to evolving demands.

    Process Responsibilities:

    1. Act as an expert in medical regulatory writing, ensuring compliance with country-specific regulations.
    2. Conduct medical regulatory writing needs analysis and implement relevant plans.
    3. Manage vendor collaborations to ensure high-quality deliverables.
    4. Develop and refine content based on stakeholder feedback.
    5. Maintain substantial understanding of the product alert process and trial transparency requirements.

    Stakeholder Engagement:

    1. Work closely with regional and area medical teams to identify medical writing needs and develop customized deliverables.
    2. Liaise with the Medical department for content preparation.
    3. Collaborate with CTT, CST, GCT, and SMT.
    4. Engage with Clinical, Medical, Pharmacovigilance, Biostatistics, Regulatory, Legal, and Corporate Affairs departments for content alignment.

    About You:

    Experience:

    • Minimum of 8 years of experience in regulatory writing for the pharmaceutical or healthcare industry.

    Soft Skills:

    • Strong stakeholder management and communication skills.
    • Ability to work independently and lead project teams.

    Technical Skills:

    • Expertise in global drug registration processes.
    • Strong knowledge of therapeutic areas and regulatory documentation.

    Education:

    • Advanced degree in life sciences, pharmacy, or a similar discipline (PhD, Master’s, Bachelor’s in Science, D Pharma, Pharm D) or a medical degree (MBBS, BDS, BAMS, BHMS, MD).

    Languages:

    • Excellent proficiency in English (reading, writing, and speaking).

    Why Join Us?

    Progress doesn’t happen without people—people from different backgrounds, locations, and roles, all united by the desire to make a difference. At Sanofi, we encourage innovation, embrace new ideas, and provide opportunities for growth. Let’s pursue progress and discover extraordinary together.

    At Sanofi, we provide equal opportunities to all individuals, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

    Learn more about our Diversity, Equity, and Inclusion initiatives at sanofi.com.

    Apply Now

     

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