Job Summary
Syneos Health is hiring a Senior Associate – Scientific Writing in Bangalore. The ideal candidate will have 4 to 6 years of experience in clinical and regulatory writing, specifically supporting global filings such as CTD Modules 2 and 5. This role requires expertise in developing, reviewing, and finalizing a range of clinical documents including protocols, CSRs, and IBs. Join us to contribute to breakthrough therapies while enjoying career development in a supportive and growth-focused environment.
Key Responsibilities
Prepare and review regulatory documents: protocols, CSRs, IBs, data summaries, etc.
Author clinical documents following lean writing principles and structured content guidelines.
Lead and coordinate document review, consensus meetings, and finalization processes.
Develop project plans and ensure adherence to timelines and quality standards.
Communicate effectively with cross-functional teams to ensure content consistency and alignment.
Conduct literature searches and stay updated on regulatory requirements.
Mentor and coach junior writing staff as needed.
Ensure compliance with company policies, training, and documentation standards.
Required Skills & Qualifications
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
4–6 years of experience in clinical & regulatory document writing (CTD Modules 2 & 5)
Proficiency in authoring CSRs, protocols, amendments, IBs
Strong knowledge of regulatory guidelines (EU, US)
Excellent scientific interpretation and lean writing skills
Project management and coordination abilities
Expertise in MS Word and document management systems
Adaptability to new tools and technologies
Ability to work independently and lead cross-functional teams
Perks & Benefits
Global exposure in clinical regulatory writing
Career development and progression opportunities
Access to technical and therapeutic area training
Supportive work culture with a focus on diversity and inclusion
Total Rewards Program and peer recognition
Company Description
Syneos Health is a leading biopharmaceutical solutions organization offering end-to-end services in clinical development, regulatory affairs, and medical writing. Our global team drives success for the world's top pharma companies, with innovative approaches to accelerate market-ready solutions.
Work Mode
On-site – Bangalore, KA, India
Call to Action
Ready to advance your career in scientific writing with a global leader? Apply now and contribute to life-changing therapies at Syneos Health!
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