About This Role
A growing biopharmaceutical company is seeking a highly collaborative Medical Writer to draft, edit, and submit high-quality, medically accurate documents, including clinical protocols and study reports. This is a key position within the Clinical Development team, offering the opportunity to make a meaningful impact across programs.
This role is based in New York City with an on-site requirement of at least three days per week. Fully remote arrangements are not available.
Job Responsibilities
Responsibilities include, but are not limited to:
- Interpret, analyze, and synthesize complex clinical data to develop high-quality scientific and regulatory documents, including protocols, amendments, briefing books, and clinical study reports
- Participate in strategic and cross-functional team meetings as needed
- Collaborate closely with project leads, biostatisticians, and other stakeholders to prioritize assignments and ensure timely, high-quality deliverables
- Prepare documents in compliance with internal standard operating procedures (SOPs)
- Contribute to timeline development, review/approval workflows, and quality control processes
- Lead cross-functional alignment on document content
- Manage outsourced medical writing activities and external vendors when applicable
- Ensure accuracy, consistency, and regulatory compliance across all documentation
Requirements / Qualifications
- Advanced scientific or clinical degree (MD, PhD, or PharmD) required
- Minimum of 6 years of relevant medical writing experience
- Demonstrated experience preparing and quality-checking clinical regulatory documents (e.g., protocols, investigator brochures, clinical study reports, summaries, and briefing documents)
- Strong understanding of pharmaceutical drug development and GxP principles
- Ability to work on-site at least three days per week
Experience, Knowledge, and Skills
- Experience in psychiatric and/or neurological therapeutic areas is a plus
- Proven track record of producing high-quality scientific and regulatory documents
- Strong ability to interpret and communicate complex clinical data clearly and effectively
- Familiarity with statistical analysis plans and data presentation (tables, figures, listings)
- Ability to collaborate across functions and drive alignment on deliverables
- Strong interpersonal skills and sound judgment when working with cross-functional teams and confidential information
- Ability to manage multiple projects in a fast-paced environment
- Adaptability to shifting priorities and deadlines
- High attention to detail and strong organizational skills
- Self-motivated with the ability to align work to broader strategic goals
...