We are currently seeking a Senior Medical Writer to join our growing team

Within the role, you will be responsible for:

- The preparation and review of clinical study outlines
- The preparation and review of the feasibility synopsis
- The preparation and review of protocols for clinical trials, Phase I to IV, and for bioavailability/bioequivalence studies
- The preparation and review of clinical study reports for Phase I to IV clinical trials and bioavailability/ bioequivalence studies for submission to regulatory authorities
- The preparation of Common Technical Documents (CTD) for regulatory authority submission
- The preparation of ICD, IB s, subject diary and other subject facing documents
- The technical review and ensuring the quality of medical writing documents
- Preparing departmental SOP under the guidance of departmental head/designee and quality assurance
- The preparation/review of SAE Narrative
- Drafting and independently managing high-quality clinical documents, ie Protocol, ICD, IB, diary, and all other documents are part of regulatory submission (eg IND, NDA, BLA, MAA, 505B2, Biosimilar, hybrid applications)
- The preparation and review of Non-clinical Overview (Module 2 4), Clinical Overview (Module 2

5), Module 2

6, Module 2

7 and briefing documents

Development of ISS and ISE text Summaries

- The drafting of Pre-IND, Pre-NDA briefing packages, SAM briefing packages, orphan drug designation feasibility reports, and expedited approval processes

- Reviewing and supporting other departments for clinical trial-related documents (eg SAP, Mock TLFs, eCRF outline, any study-specific documents, etc)
- Managing medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision





- Creating impactful and accurate content for a variety of deliverables for our clients with moderate oversight
- Understanding client expectations and meeting those expectations through teamwork, adherence to deadlines, problem-solving, and scientific knowledge

- Ensuring compliance of documentation to internal organization standards and external regulatory guidelines
- Interacting with department head and staff members in data management, biostatistics, regulatory affairs, and medical lead as necessary to create writing deliverables

- Managing the administrative requirements of the medical writing department
- Any additional responsibility given by the head of department/designee/management

Desirable Skills and Experience

- Minimum of 5 years of experience as a professional medical writer who has contributed or written many regulatory MW documents
- Expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation of regulatory MW documents

- Proficient in Word, PowerPoint, Excel, and Adobe Acrobat; for developing and editing PowerPoint slides and PDF editor for dossier compilation An advanced knowledge of PDF editor is a plus
- A basic understanding of the publication process and congress activities

- Excellent interpersonal skills for effective and professional liaison with the internal team, clients, Key Opinion Leaders, and other stakeholders
- A keen eye for accuracy
- A passion for writing and communicating science for different audiences

- Extremely high level of English fluency or English speaker
- Ability to multitask and prioritize work effectively
- Solid work ethic and ability to work as part of a cross-functional team

**Medical/Pharmacy (PhD, MBBS, MD, M

Pharma/Pharma D)**

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We encourage job seekers to verify all details directly with the employer via their official channels before applying.

📌 Marketing Surveillance (PMS) professional (Bengaluru)
🏢 Navitas Life Sciences
📍 Bengaluru