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Sr Medical Writer - Regulatory

2+ years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Writer - Regulatory (Home-Based, India)
Location: India – Home-Based
Job ID: 24006762
Updated: Today

Job Description:

Syneos Health is looking for an experienced Senior Medical Writer - Regulatory to join our home-based team in India. In this role, you will lead and manage the development of regulatory documents with minimal supervision. You will be responsible for writing and reviewing clinical documents, such as protocols, clinical study reports (CSRs), informed consent forms, IND submissions, and other regulatory documents, ensuring adherence to industry guidelines and regulations.

Key Responsibilities:

  • Lead end-to-end development of regulatory documents with minimal oversight.
  • Independently manage medical writing activities for clinical studies, coordinating with cross-functional teams.
  • Lead and participate in client meetings, presentations, and reviews.
  • Mentor less experienced writers on complex projects.
  • Develop documents including clinical study protocols, clinical study reports, informed consent forms, patient narratives, IND submissions, and Investigator brochures.
  • Identify and resolve issues during the writing process, escalating when necessary.
  • Review statistical analysis plans and ensure documents are clear, accurate, and consistent.
  • Work closely with internal teams (data management, biostatistics, regulatory affairs, medical affairs) to ensure timely document delivery.
  • Ensure compliance with regulatory standards (ICH-E3, FDA, and local guidelines).
  • Conduct online clinical literature searches and stay updated on industry practices and regulatory requirements.
  • Maintain awareness of project budgets and timelines, adhering to required administrative tasks.
  • Minimal travel may be required (less than 25%).

Qualifications:

  • Bachelor of Science (preferably) or Bachelor of Arts (Social Sciences, English, Communications) with relevant writing experience.
  • 5+ years of experience as a medical writer or in a similar role.
  • Strong experience in writing CSRs, protocols, Investigator brochures, informed consent forms, and clinical summaries.
  • In-depth knowledge of English grammar, FDA, ICH regulations, and familiarity with AMA style guide.
  • Demonstrated independence, leadership, and effective communication skills.
  • Proficient in Microsoft Word, Excel, PowerPoint, and Internet tools.
  • Ability to interpret and present clinical data and other complex scientific information.