Senior Medical Writer (CSR, IB & Protocol Development)
Updated: February 3, 2026
Location: Gurgaon, Haryana, India
Job ID: 25100336-OTHLOC-5206-2DH
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a global, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that address today’s complex healthcare and regulatory challenges.
With a patient-centric Clinical Development model, the organization continuously streamlines processes to improve efficiency, collaboration, and outcomes. Operating across more than 110 countries with over 29,000 professionals, Syneos Health is united by a shared purpose: advancing therapies that change lives.
Role Overview
The Senior Medical Writer (CSR, IB, Protocol Drafting) plays a critical role in the development and delivery of high-quality clinical and regulatory documents. This position requires strong scientific expertise, in-depth regulatory knowledge, and the ability to independently manage complex writing deliverables across multiple studies while collaborating with cross-functional teams.
This role is ideal for experienced medical writers seeking to contribute to global clinical development programs within a highly regulated biopharmaceutical environment.
Key Responsibilities
Lead the accurate, clear, and timely development of medical writing deliverables across clinical studies
Independently manage medical writing activities for assigned projects, coordinating with cross-functional stakeholders
Author, review, and finalize a wide range of documents, including:
Clinical Study Protocols and Amendments
Clinical Study Reports (CSR)
Investigator Brochures (IB)
Patient Narratives and Informed Consent Forms
Periodic Safety Update Reports (PSUR)
Clinical Development Plans and IND submissions
Integrated Summary Reports, NDA and eCTD submissions
Journal manuscripts, abstracts, posters, and scientific presentations
Ensure compliance with regulatory standards including ICH E3, FDA, EMA guidelines, company SOPs, and approved templates
Coordinate editorial, quality control, and peer review processes
Review statistical analysis plans and TFLs to ensure consistency, clarity, and scientific accuracy
Collaborate closely with biostatistics, data management, regulatory affairs, and medical affairs teams
Conduct clinical literature searches in compliance with copyright and publication standards
Mentor and provide technical guidance to junior and mid-level medical writers
Identify risks, propose solutions, and support continuous improvement initiatives
Manage assigned projects within agreed timelines and budget parameters
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline; Master’s or PhD preferred
Minimum 5–7 years of relevant experience in medical writing within a biopharmaceutical company, CRO, or medical communications agency
Proven experience authoring CSRs, Investigator Brochures, and clinical study protocols
Strong working knowledge of FDA, ICH, EMA regulations and Good Publication Practices
Advanced proficiency in English grammar and scientific writing; strong familiarity with the AMA Manual of Style
Experience supporting regulatory submissions (IND, NDA, eCTD) is highly desirable
Essential Skills
Excellent scientific writing, editing, and proofreading capabilities
Strong project management and organizational skills
Ability to interpret and present complex clinical and statistical data clearly
High proficiency in MS Office applications
Strong interpersonal, communication, and stakeholder management skills
Ability to work independently in a fast-paced, regulated environment
Why Join Syneos Health
Exposure to global clinical programs supporting FDA- and EMA-approved products
Structured career development, technical training, and leadership support
Inclusive and diverse workplace culture focused on professional growth
Opportunity to contribute to studies impacting hundreds of thousands of patients worldwide
Over the past five years, Syneos Health has supported:
94% of all Novel FDA Approved Drugs
95% of EMA Authorized Products
More than 200 clinical studies across 73,000 sites and 675,000+ trial patients
Additional Information
The responsibilities outlined above are not exhaustive and may evolve based on business needs. Equivalent combinations of education, skills, and experience will be considered. This job description does not constitute an employment contract. Syneos Health is an equal opportunity employer and is committed to providing reasonable accommodations in accordance with applicable laws.
Apply now to advance your medical writing career with a global biopharmaceutical leader.
Not ready to apply? Join the Syneos Health Talent Network to stay connected.
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