Job Description
We are seeking a highly skilled and strategic Senior Medical Writer to join our elite team at MediCore Innovations. In this pivotal role, you will translate complex clinical data into compelling narratives that drive regulatory approval and inform medical strategies. You will be part of a dynamic environment that values precision, innovation, and excellence in healthcare communication.
Why Join Us?
We offer a competitive benefits package, flexible working hours, and the opportunity to work on groundbreaking therapies.
Responsibilities
- Lead the end-to-end writing process for Clinical Study Reports (CSRs), protocols, and regulatory submissions (e.g., EMA, FDA).
- Collaborate closely with cross-functional teams, including Medical Directors, Biostatisticians, and Data Managers, to ensure accurate data interpretation.
- Ensure all documentation strictly adheres to ICH-GCP guidelines and company style guides.
- Mentor and provide feedback to junior medical writers to foster professional growth within the department.
- Manage multiple concurrent projects while maintaining strict timelines and quality standards.
- Conduct thorough literature reviews to support clinical strategy and manuscript development.
Qualifications
- Medical degree (MBBS, MD) or a Master’s/PhD in Life Sciences, Medicine, or a related field.
- Minimum of 5 years of experience in medical or scientific writing within the pharmaceutical or biotechnology industry.
- Proven track record of successful regulatory submissions and publication of peer-reviewed manuscripts.
- Native or near-native proficiency in English with exceptional command of grammar and tone.
- Expertise in authoring tools such as Author-it, MS Word, and EndNote.
- Strong organizational skills with the ability to prioritize tasks in a fast-paced, deadline-driven environment.