Senior Medical Writer & Evidence Analyst
New
Remote work flexibility within IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 3–5 years
- Required Skills
- Data Analysis
Requirements
- 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.
Responsibilities
- 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.
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