Position Overview - Medical Writer
Cerecin is seeking an experienced Medical Writer with a strong background in clinical protocol writing and expertise in Alzheimer's disease. The ideal candidate will play a pivotal role in developing high-quality, regulatory-compliant documents to support clinical trials and drug development processes. This position requires a blend of scientific knowledge, technical writing skills, and familiarity with the therapeutic landscape of Alzheimer’s disease.
Key Responsibilities
- Protocol Development: Lead the drafting, editing, and finalization of Phase1, 2 and Phase 3 clinical study protocols, amendments, and related documents, ensuring alignment with regulatory standards (e.g., ICH E6 guidelines).
- Regulatory Documentation: Prepare other essential clinical documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and regulatory submissions (e.g., INDs, NDAs).
- Alzheimer’s Disease and Neurology Expertise: Incorporate the latest research and therapeutic insights into Alzheimer’s disease into clinical documents to ensure scientific accuracy and relevance.
- Cross-Functional Collaboration: Liaise with clinical teams, statisticians, project managers, and other stakeholders to gather input and ensure consistency across documents.
- Quality Assurance: Conduct thorough reviews of documents to ensure clarity, scientific rigor, and compliance with regulatory requirements.
- Timeline Management: Develop and adhere to timelines for document preparation, review cycles, and submission deadlines.
- Mentorship: Provide guidance to junior medical writers or team members as needed.
Qualifications
- Education: Advanced degree in Life Sciences (e.g., Biology, Biochemistry, Neuroscience) or a related field; Ph.D. or equivalent preferred.
- Experience:
- Minimum of 6–8 years in medical writing within the pharmaceutical or biotechnology industry.
- Proven experience in authoring Phase 3 clinical protocols and regulatory documents.
- Demonstrated expertise in Alzheimer’s disease or related neurodegenerative disorders.
- Technical Skills:
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and document management systems (e.g., Veeva Vault).
- Familiarity with statistical concepts and clinical trial design.
- Knowledge of global regulatory requirements (FDA, EMA) for clinical documentation.
- Soft Skills:
- Exceptional written and verbal communication skills.
- Strong attention to detail and ability to synthesize complex information into clear narratives.
- Effective time management and ability to handle multiple projects simultaneously.
Preferred Certifications
- Certification from recognized organizations such as the American Medical Writers Association (AMWA) or Board of Editors in the Life Sciences (BELS).
- Good Clinical Practice (GCP) certification.
Why Join Cerecin?
Cerecin is at the forefront of developing innovative treatments for neurological diseases like Alzheimer’s. By joining our team, you will contribute directly to advancing therapies that improve patient outcomes. We offer a collaborative environment where your expertise will be valued and your work will make a meaningful impact.
