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    Senior Medical Regulatory Writer

    Sanofi
    5+ 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: Medical Regulatory Writer
    Location: Hyderabad
    Job Type: Full-time

    About Sanofi

    Sanofi Global Hub is an internal organization that centralizes processes and activities to support a wide range of functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital. Our goal is to be a strategic partner for medical, HEVA, and commercial teams at Sanofi, providing high-quality, timely regulatory and medical writing support.

    Key Accountabilities:

    As a Medical Regulatory Writer, your primary responsibilities will involve creating and editing high-quality safety and clinical documents for regulatory submissions, ensuring they comply with internal and external standards. Your key tasks include:

    Document Writing & Editing:

    • Write and/or edit clinical and safety documents such as Clinical Study Reports (CSR), Periodic Benefit-Risk Evaluation Reports (PBRER), Addendum to Clinical Overviews (ACO), Disease and Product ID Cards, clinical evaluation reports, product alerts, and trial transparency documents.
    • Ensure that all documents are delivered on time, in compliance with internal standards and external regulations.

    Collaboration & Mentorship:

    • Work independently on assigned documents, while mentoring and supporting less experienced medical writers.
    • Collaborate effectively with global and local teams, including Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and other stakeholders.
    • Participate in planning and data presentation for document creation, and review content created by peer writers.

    Stakeholder Engagement:

    • Maintain effective relationships with stakeholders within allocated global business units and products.
    • Liaise with various departments, such as Medical, Pharmacovigilance, Biostats, Regulatory, and Corporate Affairs, to ensure the timely and accurate delivery of medical regulatory documents.

    Performance and Process Management:

    • Provide deliverables such as PBRER, ACO, CSR, clinical evaluation reports, Product Alerts, and manage trial information postings to platforms like CT.gov, EUCTR, and EUDRACT.
    • Ensure that the regulatory writing process follows the company’s quality standards and is audit-ready.
    • Track submissions, file documents in the appropriate systems, and ensure compliance with internal policies and external regulations.

    Regulatory Knowledge & Documentation:

    • Stay abreast of evolving Sanofi policies and quality documents.
    • Prepare or review stand-by statements and questions & answers (SBS QA) as part of managing product alerts.
    • Assist in the development of action plans based on customer feedback and improve course content and delivery as necessary.

    Skills, Experience & Knowledge Requirements:

    Experience:

    • >5 years of experience in regulatory writing in the pharmaceutical/healthcare industry.
    • Proven expertise in writing complex clinical and safety documents for regulatory submissions.

    Education:

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

    Skills & Competencies:

    • Stakeholder management and vendor management experience.
    • Excellent communication skills and ability to work independently and within a team environment.
    • Strong medical writing and editing skills, with the ability to interpret scientific data and summarize it effectively for diverse audiences.
    • Proficiency in data retrieval, scientific literature screening, and technical editing.
    • Familiarity with ICH, GCP/GVP, and regulatory guidelines.
    • Knowledge of medical regulatory processes and the ability to summarize complex scientific information.

    Technical Skills:

    • Well-versed with common computer applications (MS Word, Excel, PowerPoint, SharePoint).
    • Experience with digital tools such as Veeva Vault RIM is a plus.

    Language Skills:

    • Fluency in English, both written and spoken.

    Why Sanofi?

    At Sanofi, we strive to provide an inclusive, diverse, and empowering work environment where people can grow, innovate, and contribute to life-changing solutions. Join us and be part of a team dedicated to making miracles happen.

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

    Pursue Progress. Discover Extraordinary.
    Explore new opportunities to innovate and impact global healthcare, and make a difference with Sanofi!

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