Associate Director, Medical Writer

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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