Job Description
Are you a passionate storyteller with a scientific mind? BioSynth Solutions is seeking a highly skilled Senior Medical Writer to lead our content strategy in the rapidly evolving HealthTech sector.
We are a mission-driven organization dedicated to revolutionizing patient outcomes through data-driven insights and cutting-edge medical communication. In this pivotal role, you will translate complex clinical research into compelling narratives that resonate with regulators, clinicians, and patients alike.
Why Join Us?
- Work with a world-class team of data scientists and medical experts.
- Shape the future of healthcare communication.
- Competitive compensation and equity package.
Key Responsibilities:
Responsibilities
- Lead the end-to-end creation of high-level clinical and regulatory documents, including Clinical Study Reports (CSRs) and Investigator Brochures.
- Collaborate with cross-functional teams of physicians, data analysts, and designers to distill complex datasets into clear, accurate, and persuasive medical content.
- Ensure all documentation adheres to global regulatory standards (FDA, EMA) and internal quality control protocols.
- Develop scientific white papers, abstracts, and journal submissions for peer-reviewed publications.
- Mentor junior medical writers and establish editorial best practices within the content team.
- Conduct thorough literature reviews and maintain up-to-date knowledge of therapeutic areas and industry trends.
Qualifications:
Qualifications
- Master’s degree or PhD in Life Sciences, Medicine, Pharmacy, or a related field (MD, PharmD, or PhD preferred).
- Minimum of 5+ years of experience in medical writing, specifically within the pharmaceutical, biotechnology, or HealthTech industries.
- Proven track record of successfully authoring regulatory submissions or clinical study reports.
- Exceptional command of the English language with a keen eye for detail and grammar.
- Familiarity with regulatory frameworks (e.g., ICH-GCP, FDA 21 CFR Part 11) is highly desirable.
- Strong interpersonal skills with the ability to communicate complex concepts to diverse audiences.
- Proficiency in medical writing software (e.g., Author-it, AuthorPoint) and Microsoft Office Suite.
Skills: Medical Writing, Clinical Research, Regulatory Affairs, HealthTech, Scientific Communication, ICH-GCP, Medical Editing, Biotechnology, Clinical Documentation, Data Analysis.