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Medical Regulatory Writer

2+ years
Not Disclosed
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: Flexible, with global opportunities
Job Type: Full-time

About Sanofi

At Sanofi, we are committed to improving the health and well-being of people around the world. We create breakthrough medicines and innovative healthcare solutions to help people live healthier lives. We strive to make a positive impact through science, innovation, and collaboration, building strong relationships and a diverse, inclusive work environment where all employees can thrive.

Job Overview

Sanofi's Business Operations team seeks a Medical Regulatory Writer to contribute to the development and maintenance of high-quality safety documents and medical content for regulatory submissions. This role involves collaborating across multiple teams, including Medical, HEVA, and Commercial, to produce accurate and timely documents that comply with internal and external guidelines and regulations. The position requires a strong understanding of medical writing in the pharmaceutical industry and the ability to manage multiple tasks while working independently and with others.

Key Responsibilities

  • Document Creation: Write and edit high-quality safety and medical documents, including Periodic Benefit-Risk Evaluation Reports (PBRER), clinical overviews, product alerts, and trial transparency documents, ensuring compliance with regulatory guidelines.
  • Stakeholder Collaboration: Develop and maintain effective relationships with internal teams such as Scientific Communication, Pharmacovigilance, Regulatory, and Clinical/Medical teams to meet the needs of medical regulatory writing.
  • Process Management: Manage the planning, execution, and maintenance of regulatory documents, ensuring deliverables meet timelines and quality standards. Prepare stand-by statements and Q&A documents for product alerts.
  • Content Review: Review and edit scientific data, interpret medical literature, and ensure that documents are tailored for specific audiences. Stay informed about Sanofi policy and evolving quality documents.
  • Vendor and Stakeholder Engagement: Work closely with selected vendors and manage partnerships to deliver high-quality content. Ensure effective communication with all stakeholders, including legal, regulatory, and corporate affairs teams.

Experience & Qualifications

  • Experience: Minimum of 2 years in regulatory writing in the pharmaceutical or healthcare industry.
  • Soft Skills: Excellent communication, stakeholder management, and vendor management skills. Ability to work independently or as part of a team.
  • Technical Skills: Strong medical writing and editing skills, experience with ICH and GCP/GVP, data retrieval, and summarizing scientific information. Proficiency in relevant computer applications.
  • Education: Advanced degree in life sciences, pharmacy, or a related discipline (PhD, Masters, or Bachelor’s degree; PharmD, MD, or equivalent).
  • Languages: Fluency in English, both written and spoken.

Why Sanofi?

At Sanofi, we are dedicated to fostering diversity, inclusion, and progress. We offer a supportive and inclusive environment where individuals from diverse backgrounds can thrive and contribute to groundbreaking healthcare solutions. We are committed to continuous learning and professional growth, making it an exciting place to build a career.

Equal Opportunity Employer

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

Pursue progress. Discover extraordinary.
Join us at Sanofi and help shape the future of healthcare.