This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Medical Writing based in the United States.
This is a senior scientific writing leadership role within a fast-growing clinical-stage environment focused on advancing innovative therapies for patients with severe autoimmune diseases. The position plays a critical part in shaping and delivering high-quality clinical, nonclinical, and regulatory documentation across all phases of drug development. You will lead the preparation of complex regulatory submissions, ensuring clarity, scientific accuracy, and compliance with global standards. The role combines hands-on authorship with strategic oversight of medical writing processes and standards. You will also guide and mentor a team of writers while collaborating closely with cross-functional stakeholders. This is an opportunity to influence both late-stage regulatory strategy and the evolution of internal medical writing capabilities in a highly dynamic setting.
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 manage multiple priorities in a fast-paced, deadline-driven environment.
- Strong organizational, time management, and autonomous working capabilities, with a collaborative mindset.
- Proficiency in MS Office; familiarity with Veeva Vault and document review systems preferred.
- Exposure to pharmacovigilance documentation is a plus.
- East Coast US location strongly preferred.
Benefits:
- Competitive base salary range of $164,000–$225,500 USD annually (depending on experience and internal equity).
- Eligibility for short-term and long-term incentive programs.
- Comprehensive benefits package including health coverage and retirement savings plans.
- Opportunity to work in a highly innovative, science-driven biotech environment.
- Remote-friendly structure with collaboration across global teams.
- Strong focus on professional development, leadership growth, and cross-functional exposure.
- Inclusive workplace culture with equal opportunity employment practices.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
