This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Writer & Evidence Analyst based in India.
This role plays a key part in developing high-quality scientific and regulatory medical writing deliverables that support global clinical research and evidence generation initiatives. You will work across a range of therapeutic areas, contributing to documents that directly support regulatory submissions, publications, and scientific communications. The position involves close collaboration with cross-functional clinical and research teams in a fast-paced, quality-driven environment. You will be responsible for translating complex clinical data into clear, accurate, and publication-ready content aligned with global regulatory standards. The role also offers exposure to diverse projects including manuscripts, abstracts, posters, and evidence synthesis outputs. It is an opportunity to contribute meaningfully to advancing clinical science and improving decision-making in drug development.
Accountabilities:
In this role, you will be responsible for producing, reviewing, and ensuring the scientific and regulatory quality of medical writing deliverables across multiple therapeutic areas and global submissions.
- Author and review regulatory medical writing documents including patient narratives, clinical study reports (CSRs), protocols, investigator brochures, and other submission-related materials.
- Develop manuscripts, abstracts, posters, and evidence synthesis outputs for scientific publication and communication purposes.
- Ensure all deliverables are scientifically accurate, clearly written, and aligned with global regulatory and editorial standards.
- Perform quality control reviews including scientific review, proofreading, and compliance checks of written materials.
- Apply relevant regulatory guidelines (ICH, GPP, and other industry standards) in all writing activities.
- Collaborate with cross-functional teams to support publication strategy and evidence dissemination activities.
- Contribute to SOP development, documentation improvements, and audit readiness initiatives.
- Support junior writers and contribute to broader team capability development when required.
- Adapt writing style and timelines based on therapeutic area and client-specific requirements.
Requirements
The ideal candidate brings strong medical writing expertise, scientific understanding, and the ability to manage multiple complex deliverables in a regulated environment.
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related fields (PharmD, M.Pharm, PhD, MD preferred).
- 3–5 years of experience in medical writing, regulatory writing, or scientific communications.
- Strong understanding of clinical research processes, drug development, and regulatory documentation standards.
- Excellent written and verbal communication skills with strong attention to scientific detail.
- Proficiency in Microsoft Office Suite, especially advanced MS Word formatting and documentation tools.
- Ability to interpret clinical and scientific data accurately and translate it into clear written content.
- Strong organizational skills with the ability to manage multiple projects and meet strict deadlines.
- Familiarity with regulatory guidelines such as ICH and Good Publication Practice (GPP).
- Ability to work independently as well as collaboratively in cross-functional teams.
- Strong analytical thinking, adaptability, and problem-solving mindset in dynamic environments.
Benefits
- Competitive compensation package aligned with experience
- Remote work flexibility within India
- Exposure to global clinical research and regulatory writing projects
- Opportunity to work across multiple therapeutic areas, including oncology and complex studies
- Learning and development opportunities in medical writing and evidence generation
- Collaborative, science-driven international work environment
- Participation in high-impact clinical research documentation supporting drug development.