Syneos Health®, a global leader in biopharmaceutical solutions, is hiring a Senior Medical Writer (CTT – Disclosure) for its Pune, India location (with remote flexibility). This role is ideal for experienced professionals with 4–5 years of hands-on expertise in disclosure platforms like Disclose/PRIME and User Acceptance Testing (UAT) activities.
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If you are passionate about medical writing, clinical research, and regulatory submissions, this is a career-defining opportunity with one of the world’s most trusted clinical development organizations.
🔑 Key Responsibilities
- Lead the drafting, review, and submission workflow in disclosure platforms (Disclose/PRIME).
- Perform User Acceptance Testing (UAT) activities to ensure system compliance.
- Author, review, and finalize a wide range of medical writing documents, including:
- Clinical Study Protocols & Amendments
- Clinical Study Reports & Patient Narratives
- Investigator Brochures & Informed Consents
- Plain Language Summaries & Periodic Safety Update Reports
- Clinical Development Plans, IND/NDA/eCTD submissions
- Journal manuscripts, abstracts, posters, and presentations
- Ensure compliance with ICH E3 guidelines, FDA/EMA standards, and internal SOPs.
- Mentor and guide junior writers on complex medical writing deliverables.
- Collaborate with cross-functional teams (biostatistics, data management, regulatory affairs, medical affairs).
- Conduct literature searches and ensure copyright compliance.
🎓 Qualifications & Skills
- Bachelor’s degree in Life Sciences or Pharmacy (Master’s/PharmD preferred).
- Minimum 4 years of relevant experience in disclosure platforms (mandatory).
- Strong knowledge of FDA, EMA, and ICH regulations.
- Familiarity with AMA Manual of Style and scientific communication best practices.
- Excellent command of English, with strong proofreading and editing skills.
- Proficiency in MS Office tools.
- Strong project management, organizational, and presentation skills.
🌟 Why Join Syneos Health?
- Work with a global biopharma leader engaged in 94% of all novel FDA approvals in the last 5 years.
- Be part of a remote-friendly culture with flexible work arrangements.
- Comprehensive career development and training programs.
- Supportive environment fostering diversity, inclusion, and growth.
- Competitive compensation package and performance rewards.
📩 How to Apply
Interested candidates can send their CVs to:
📧 anamika.jayprakash@syneoshealth.com
👉 Mention “Application for Sr. Medical Writer (Disclosure) – Linkedin” in the subject line.
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