Join PPD, part of Thermo Fisher Scientific, as a Principal Medical Writer. In this role, you will be responsible for creating, reviewing, and managing clinical regulatory documents for a dedicated client within the Functional Service Provider (FSP) space. You will apply your strong scientific understanding and exceptional writing skills to communicate complex information clearly and concisely.
What You'll Do
- Lead the development, writing, and editing of complex clinical and regulatory documents.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure accurate and timely document completion.
- Ensure documents align with regulatory guidelines, company standards, and industry best practices.
- Provide strategic input and guidance on document content, structure, and presentation.
- Mentor and provide oversight to junior medical writers to ensure high-quality deliverables.
- Manage multiple writing projects simultaneously and prioritize tasks effectively.
- Stay current with industry trends, guidelines, and regulatory requirements.
What We're Looking For
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification.
- Regulatory writing experience comparable to 8+ years in a core Regulatory Medical Writer role.
- Experience working in the pharmaceutical/CRO industry.
- Experience in managing and directing complex medical writing projects.
- Extensive experience in Phase 3 CSRs and/or protocol development.
Nice to Have
- Advanced degree.
- EU CTR experience.
- Experience working on structured content management systems and AI-driven content creation.
- Familiarity with Natural Language Generation.
Technical Stack
- Structured Content Authoring systems
- Automation tools
Team & Environment
You will be part of the Medical Writing FSP Team in India, dedicated to a specific client.
Benefits & Compensation
- Award-winning learning and development programme.
- Extensive benefits package based around the health and well-being of employees.
- Flexible working culture that values work-life balance.
- Collaborative environment with teams eager to share expertise.
- Competitive salary.
Work Mode
This is an onsite position located in India.
PPD, part of Thermo Fisher Scientific, is an equal opportunity employer committed to enabling customers to make the world healthier, cleaner, and safer. We operate as one team of over 100,000 colleagues, guided by our values of Integrity, Intensity, Innovation, and Involvement.
