Director of Medical Writing
Location: New York, NY
Company: Genesis10
Job Description Apply Now
ApTask Global Workforce (AGW) is seeking a Director of Medical Writing for a remote position with a leading pharmaceutical company located in New York, New York. This is a direct hire position and is 100% remote.
Summary:
Our client is seeking its first Director of Medical Writing to establish and lead the medical writing function at a critical stage of clinical and regulatory advancement. Reporting to the SVP of Regulatory Affairs, this individual will be responsible for authoring, overseeing, and driving the strategy for key clinical documents (e.g., Investigators Brochure, Clinical Efficacy Summary, Clinical Safety Summary, etc.) in support of IND and future NDA submissions.
This is a highly strategic yet hands-on role requiring deep expertise in regulatory writing, strong cross-functional leadership, and the ability to build scalable processes in a lean environment. The Director will also be expected to utilize and optimize the use of AI-enabled tools to enhance writing efficiency, consistency, and quality across the organization.
Key Responsibilities:
Education & Experience
If you have the described qualifications and are interested in this exciting opportunity, apply today!
ApTask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Summary:
Our client is seeking its first Director of Medical Writing to establish and lead the medical writing function at a critical stage of clinical and regulatory advancement. Reporting to the SVP of Regulatory Affairs, this individual will be responsible for authoring, overseeing, and driving the strategy for key clinical documents (e.g., Investigators Brochure, Clinical Efficacy Summary, Clinical Safety Summary, etc.) in support of IND and future NDA submissions.
This is a highly strategic yet hands-on role requiring deep expertise in regulatory writing, strong cross-functional leadership, and the ability to build scalable processes in a lean environment. The Director will also be expected to utilize and optimize the use of AI-enabled tools to enhance writing efficiency, consistency, and quality across the organization.
Key Responsibilities:
- Regulatory & Clinical Writing Leadership
- Our client Lead the authoring, review, and approval of key clinical and regulatory documents, including:
- Our client Clinical Study Protocols (Phases 1–3)
- Our client Clinical Study Reports (CSRs)
- Our client Investigator's Brochures (IBs)
- Our client Integrated Summaries of Safety (ISS) and Efficacy (Client)
- Our client Common Technical Document (CTD) modules (primarily Module 2 and 5)
- Our client Ensure consistency, quality, and strategic alignment across all documents
- Our client Translate complex clinical, statistical, and scientific data into clear, concise, and submission-ready narratives
- Our client Establish and scale the Medical Writing function, including:
- Our client Standard templates, style guides, and document standards
- Our client Writing processes, workflows, and governance models
- Our client Quality control and document review practices
- Our client Select, onboard, and manage external medical writing vendors and consultants
- Our client Define the long-term operating model for Medical Writing as the company approaches NDA and commercialization
- Our client Evaluate, implement, and optimize AI-based tools to enhance medical writing productivity, accuracy, and consistency
- Our client Establish best practices for responsible and compliant use of AI in regulatory writing
- Our client Drive innovation in document development, including automation, data integration, and content reuse strategies
- Our client Train cross-functional teams on effective and compliant use of AI-assisted writing tools
- Our client Partner closely with Regulatory Affairs to align on submission strategy, timelines, and health authority expectations
- Our client Collaborate with external Clinical Research Organizations and internal Clinical Development team to create, review and finalize protocols, clinical study reports, annual reports, and other similar documents
- Our client Work with Biostatistics and Data Management to ensure accurate interpretation and presentation of data
- Our client Engage Clinical Operations to ensure alignment between study execution and documentation
- Our client Support responses to regulatory agency questions and interactions
- Our client Lead document planning and timeline development aligned with clinical milestones and regulatory submissions
- Our client Coordinate cross-functional contributors and reviewers to ensure efficient document development
- Our client Identify risks and proactively manage competing priorities in a fast-paced, milestone-driven environment
Education & Experience
- Our client Bachelor's degree is required. Advanced degree desirable but not required such as PhD, PharmD, MD, or equivalent in life sciences or Master's degree with 5+ years of relevant experience.
- Our client 5-10 years of medical writing experience in the biopharmaceutical industry
- Our client Demonstrated experience leading medical writing activities for both IND and NDA submissions
- Our client Strong experience supporting Phase 2 and Phase 3 clinical programs
- Our client Prior experience in a late-stage or pre-commercial biotech environment strongly preferred
- Our client CNS or neuropsychiatric therapeutic area experience is a plus
- Our client Deep knowledge of ICH guidelines, GCP, and global regulatory requirements
- Our client Expertise in CTD structure and regulatory submission processes
- Our client Proven ability to synthesize complex clinical and statistical data into clear narratives
- Our client Experience with electronic document management systems and submission tools
- Our client Hands-on experience using AI tools (e.g., generative AI, document automation platforms) in medical writing or related workflows
- Our client Understanding of risks, limitations, and compliance considerations for AI use in regulated environments
- Our client Ability to balance innovation with regulatory rigor and data integrity
- Our client Exceptional writing, editing, and communication skills
- Our client Strong strategic thinking combined with attention to detail
- Our client Excellent project management and organizational abilities
- Our client Ability to influence cross-functional stakeholders without direct authority
- Our client Builder mindset with the ability to create and scale a function from the ground up
If you have the described qualifications and are interested in this exciting opportunity, apply today!
ApTask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.