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Senior Medical Regulatory Writer

5+ years
Not Disclosed
10 Dec. 3, 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


About the Job

As part of the Sanofi Global Hub team in India, you will play a key role in supporting Sanofi’s global initiatives across various therapeutic areas. This team focuses on creating high-quality safety and clinical documents that meet internal and external guidelines while fostering collaboration with global medical, regulatory, and pharmacovigilance teams.

This role demands independence, expertise in regulatory writing, and leadership in mentoring and reviewing the work of medical writers.


Main Responsibilities

Document Creation

  • Write and edit high-quality regulatory and safety documents, including:
    • Periodic Benefit-Risk Evaluation Reports (PBRER)
    • Clinical Study Reports (CSR)
    • Addendum to Clinical Overviews (ACO)
    • Disease and Product ID Cards
    • Clinical Evaluation Reports
    • Trial Transparency Documents
  • Ensure timely delivery and compliance with internal and external standards.

Collaborative Expertise

  • Actively engage in planning analyses and data presentations.
  • Develop and maintain Therapeutic Area (TA) expertise.
  • Collaborate with global/local teams in Scientific Communication, Pharmacovigilance, Regulatory Writing, and Corporate Affairs.

Peer Review and Mentorship

  • Act as a buddy or mentor to medical writers.
  • Review peers’ documents for accuracy and consistency.

Stakeholder Management

  • Build and maintain effective relationships with stakeholders, including:
    • Medical Scientific Community
    • Pharmacovigilance Teams
    • Regulatory and Legal Teams
  • Proactively address needs for customized deliverables.

Operational Excellence

  • Conduct comprehensive regulatory writing needs analysis.
  • Manage deliverables, such as PBRERs, product alerts, trial transparency postings, and clinical evaluation reports.
  • Maintain up-to-date knowledge of Sanofi Policy and Quality Document standards.
  • Ensure audit-readiness by tracking and archiving materials in relevant systems.

Process Optimization

  • Design action plans based on customer feedback.
  • Improve course content and delivery for internal processes.
  • Prepare and review Stand-By Statements (SBS) and Q&A Documents for product alerts.

About You

Experience

  • 5+ years of experience in regulatory writing for the pharmaceutical/healthcare industry.

Education

  • Advanced degree in Life Sciences, Pharmacy, or a related discipline (e.g., PhD, Master's, MBBS, BDS, BAMS, BHMS, MD, PharmD).

Technical Skills

  • Expertise in:
    • Regulatory writing, editing, and compliance.
    • Data interpretation and literature screening.
    • Knowledge of ICH, GCP/GVP, and regulatory guidelines.
    • Proficiency in relevant computer applications.

Soft Skills

  • Strong communication and stakeholder management skills.
  • Leadership and mentoring abilities.
  • Ability to work independently and as part of a team.

Languages

  • Fluent in English (reading, writing, and speaking).

Why Join Sanofi?

  • Innovative Environment: Collaborate with global teams in advancing healthcare.
  • Growth Opportunities: Develop skills and progress in a global organization.
  • Comprehensive Benefits:
    • Competitive compensation
    • Inclusive wellness programs
    • 14 weeks of gender-neutral parental leave
  • Diversity & Inclusion:
    • Experience an equitable workplace fostering diverse perspectives.

Pursue Progress. Discover Extraordinary.

Sanofi is committed to creating an inclusive and equal-opportunity workplace. Explore more about our Diversity Equity and Inclusion initiatives at sanofi.com.