Company
Biotech
AssociateDirector,MedicalWriting
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“Associate Director, Medical Writing. Skills: Medical writing, Regulatory documents, Clinical drug development. Lead authorship and development of regulatory and clinical. Ensure scientific content is accurate”
What You'll Achieve.
Ensure high-quality outputs within project deadlines
Industry & Context.
Interpret complex scientific data; Translate data into documents
What They're Looking For.
Must Have
Bachelor’s degree in a scientific, clinical, or related discipline, Minimum of 5 years of sponsor-level pharmaceutical or biotech medical writing CRO experience, Experience authoring eCTD Modules 2 and 5 for global regulatory submissions, Deep understanding of clinical drug development, Familiarity with global regulatory guidance, Excellent ability to interpret complex scientific data, Excellent written and verbal communication skills in fluent or native-level American English, Ability to manage multiple priorities, Organizational, time management, and autonomous working capabilities, Proficiency in MS
Nice to Have
PhD preferred, Veeva Vault and document review systems preferred, Exposure to pharmacovigilance documentation is a plus, East Coast US location strongly preferred
What You'll Do.
Lead authorship and development of regulatory and clinical
Ensure scientific content is accurate
Ensure content is well-structured
Ensure content is aligned with regulatory expectations
Collaborate with SMEs
Collaborate with clinical teams
Collaborate with statisticians
Collaborate with medical directors
Oversee inspection readiness
Ensure adherence to internal standards
Ensure adherence to external standards
Ensure adherence to medical writing best practices
Develop document standards
Enforce document standards
Manage internal medical writers
Manage external vendors
Coordinate deliverables
Contribute to medical writing strategy
Contribute to medical writing infrastructure
Contribute to departmental objectives
How You'll Work.
Team & Collaboration
SMEs; Clinical teams; Statisticians; Medical directors; Cross-functional teams
Communication Scope
Written communication; Verbal communication
Process & Methodology
Timeline management, Deliverable coordination
Full Job Description
## Accountabilities Lead the authorship and development of key regulatory and clinical documents across phases 1–4, including protocols, clinical study reports, investigator brochures, informed consent forms, eCTD modules (INDs and BLAs), briefing documents, and other regulatory submissions such as PIPs, ODDs, aggregate reports, and RFIs. Ensure scientific content is accurate, well-structured, and aligned with regulatory expectations by collaborating with SMEs, clinical teams, statisticians, and medical directors. Oversee inspection readiness and ensure adherence to internal and external regulatory standards and medical writing best practices. Develop and enforce document standards, templates, style guides, and lexicons to ensure consistency across programs. Manage and mentor internal medical writers, contractors, and external vendors contributing to multiple development programs. Coordinate timelines and deliverables across cross-functional teams to ensure high-quality outputs within project deadlines. Contribute to the evolution of medical writing strategy, infrastructure, and departmental objectives within a fast-paced development environment. Requirements: Bachelor’s degree in a scientific, clinical, or related discipline required; PhD preferred. Minimum of 5 years of sponsor-level pharmaceutical or biotech medical writing experience; CRO experience considered. Strong experience authoring eCTD Modules 2 and 5 for global regulatory submissions. Deep understanding of clinical drug development, including trial phases, regulatory processes, and submission requirements. Familiarity with global regulatory guidance applicable to medical writing deliverables. Excellent ability to interpret complex scientific data and translate it into clear, accurate regulatory documents. Strong proofreading skills with attention to compliance, consistency, and regulatory accuracy. Excellent written and verbal communication skills in fluent or native-level American English. Ability to m
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