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Medical Regulatory Writer

2+ 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: Medical Regulatory Writer
Location: Flexible (India-based team with global collaboration)


About the Job

Join Sanofi Business Operations, a centralized organization supporting global functions in Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D. As a Medical Regulatory Writer, you will contribute to developing and delivering high-quality medical regulatory documents for Sanofi's global operations, ensuring compliance with industry standards and internal policies.

This position offers an exciting opportunity to engage with diverse teams and projects while developing expertise across therapeutic areas and regulatory domains.


Main Responsibilities

Content Development

  • Write and/or edit high-quality regulatory and safety documents such as:
    • Periodic Benefit-Risk Evaluation Reports (PBRER)
    • Addendum to Clinical Overviews (ACO)
    • Disease and Product ID Cards
    • Product Alerts
    • Trial Transparency Documents
  • Ensure timely delivery of high-quality medical documents compliant with internal and external standards.

Collaboration and Expertise

  • Work with global/local Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and Regulatory Teams.
  • Actively participate in the planning of data analysis and presentations.
  • Develop and maintain therapeutic area expertise to enhance document quality.

Stakeholder Engagement

  • Foster effective relationships with stakeholders, including the Medical Scientific Community, Clinical Teams, and Pharmacovigilance Departments.
  • Collaborate with cross-functional teams to identify and fulfill medical writing needs.

Process Optimization

  • Conduct comprehensive medical regulatory writing needs analyses for assigned medical teams.
  • Author, review, and manage deliverables while ensuring compliance with country-specific regulatory requirements.
  • Maintain up-to-date knowledge of relevant Sanofi Policies, Quality Documents, and industry standards (e.g., ICH, GCP/GVP).
  • Track postings, archive materials, and ensure audit-readiness.

Training and Knowledge Sharing

  • Assist peers and junior writers in skill development through mentoring and sharing expertise.

About You

Experience

  • >2 years of experience in regulatory writing within the pharmaceuticals/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

  • Proficiency in:
    • Technical writing and editing
    • Data retrieval and scientific interpretation
    • Knowledge of ICH, GCP/GVP, and regulatory standards
    • Tools for managing regulatory content

Soft Skills

  • Strong stakeholder and vendor management abilities.
  • Effective communication and teamwork skills.
  • Capability to work independently while managing timelines and risks.

Languages

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

Why Join Sanofi?

  • Innovative Work Environment: Collaborate with global teams at the forefront of healthcare.
  • Career Growth: Diverse opportunities for advancement and skill development.
  • Comprehensive Benefits:
    • Competitive rewards package
    • Inclusive healthcare and wellness programs
    • 14 weeks of gender-neutral parental leave
  • Diversity & Inclusion:
    • Be part of an organization committed to fostering an equitable and inclusive workplace for all.

Pursue Progress. Discover Extraordinary.

Sanofi is proud to offer equal opportunities to all individuals, ensuring a diverse, innovative, and empowering work environment.

Explore more about Sanofi's Diversity Equity and Inclusion initiatives at sanofi.com.