Job Description
Position: Senior Medical Writer
Department : Clinical Development
Reports to: Director, Clinical Development
Employment Type: Full-time, Exempt
Location: New Jersey, US Position Overview We are looking for an experienced Medical Writer to develop clear, high-quality clinical and regulatory documents that adhere to industry standards and regulatory guidelines. This role involves close collaboration with cross-functional teams-including Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs-to craft scientifically robust and regulatory-compliant content.
Key Responsibilities
Regulatory & Clinical Document Development
- Author and edit clinical and regulatory documents such as:
- Study protocols and amendments
- Clinical study reports (CSRs)
- Investigator's brochures (IBs)
- Informed consent forms (ICFs)
- Regulatory submission documents (e.g., INDs, NDAs, BLAs, MAAs)
- Periodic safety reports and risk management plans
- Briefing materials for regulatory authorities (FDA, EMA, etc.)
- Pediatric investigation plans and orphan drug designation requests
- Responses to regulatory inquiries
Clinical & Scientific Content Support - Work with clinical teams to develop clinical development plans, statistical analysis plans, and study protocols aligned with study objectives and regulatory requirements.
- Interpret complex scientific and clinical data, translating findings into clear and concise documentation.
- Ensure consistency and accuracy across all documents, maintaining scientific integrity and regulatory compliance.
Regulatory Compliance & Best Practices - Ensure all documents meet ICH, GCP, FDA, EMA, and other applicable guidelines.
- Stay informed about evolving regulatory standards and medical writing best practices.
Cross-Functional Collaboration & Document Review - Partner with clinical, regulatory, and biostatistics teams to ensure alignment on messaging and compliance.
- Review and refine documents developed by internal and external stakeholders to ensure clarity, accuracy, and adherence to guidelines.
- Manage document timelines, balancing multiple projects with shifting priorities.
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Qualifications & Experience Education: - Advanced degree (PhD, MD, PharmD, or MSc) in a life sciences, medical, or pharmaceutical field.
Experience: - 3-5+ years of experience in medical writing within the pharmaceutical, biotech, or CRO industry.
- Strong expertise in drafting regulatory and clinical trial documents for drug development.
- Knowledge of neurology, epilepsy, or related therapeutic areas is a plus.
- Experience working across Phase I-IV clinical trials preferred.
Skills & Competencies: - Deep understanding of clinical research, drug development, regulatory requirements, and biostatistics.
- Strong grasp of medical terminology and ability to synthesize complex clinical data.
- Familiarity with coding dictionaries such as MedDRA and WHODrug.
- Proficiency in industry guidelines (ICH, GCP) and regulatory submission processes (FDA, EMA, etc.).
- Excellent scientific writing, document structuring, and editing skills.
- Ability to communicate complex scientific information to diverse audiences.
- Strong project management and organizational skills, with the ability to manage multiple deadlines.
- Proficiency in Microsoft Office Suite and document management systems.
- Experience with Veeva Vault and regulatory publishing platforms is a plus.
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Preferred Attributes - Detail-oriented, analytical mindset with the ability to synthesize and present complex information effectively.
- Self-motivated team player with strong interpersonal and collaboration skills.
- Ability to adapt to change and manage multiple priorities in a dynamic, fast-paced environment.
- Excellent verbal and written communication skills.
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Job Tags
Permanent employment, Full time, Shift work,