Senior Level Associate Director Medical Writing Jobs
Senior level associate director medical writing jobs place experienced professionals in charge of regulatory document strategy, submission-ready deliverables, and the writing teams or cross-functional groups that execute them. Openings concentrate in Biotechnology & Pharmaceuticals and Healthcare & Medical Services, with a strong mix of remote and hybrid roles, and employers like Alkermes, Incyte Corporation, and Nurix Therapeutics hiring at this level now.
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Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients.
POSITION DESCRIPTION
The Opportunity
- Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as:
- Clinical study protocols and clinical protocol amendments
- Clinical study reports
- Investigator’s brochures and annual updates
- IND submissions and annual reports
- Lay-person summaries
- Integrated summary reports
- Clinical, nonclinical, and multidisciplinary information amendments
- NDA, BLA, MAA, and (e)CTD submissions
- Risk Management Plans
- Health authority responses
- Briefing documents, ODDs, BTDs/PRIME, FTD, and similar designations
- Review, edit, and QC documents developed by other authors or medical writers
- Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style
- Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives
- Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates
- Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed
WHAT YOU’LL BRING
- 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
- Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs
- Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus
- Ability to work effectively and lead in cross-functional working groups
- Excellent communication skills, organizational skills, and attention to detail
- Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Knowledge of health authority requirements, ICH guidelines, and submission-ready standards relevant to document authoring, including eCTD and submission lifecycle management
- Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and Veeva RIM Suite
- Expertise in Microsoft Word (including use of customized toolbars/templates) and document management systems
SALARY RANGE
- Salary Range: $216,400 - $234,800
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.
LOCATION
Location: Onsite – Brisbane, CA
FIT WITH NURIX CULTURE AND VALUES
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
ABOUT NURIX THERAPEUTICS
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
INTRODUCTION
Help shape how Nurix communicates its science to health authorities and the world. As Associate Director, Regulatory & Medical Writing, you’ll independently lead the authoring, review, and approval of critical regulatory documents across our pipeline — from clinical protocols to health authority submissions. It’s a chance to bring clarity and strategic messaging to the documents that move our therapies through development and toward patients.
POSITION DESCRIPTION
The Opportunity
- Author and manage authoring of Regulatory & Medical Writing documents together with cross-functional collaborators; ensure content consistency within a document and across documents for a particular asset, including the development of strategic messaging and data presentation in accordance with Nurix standards and health authority requirements, for documents such as:
- Clinical study protocols and clinical protocol amendments
- Clinical study reports
- Investigator’s brochures and annual updates
- IND submissions and annual reports
- Lay-person summaries
- Integrated summary reports
- Clinical, nonclinical, and multidisciplinary information amendments
- NDA, BLA, MAA, and (e)CTD submissions
- Risk Management Plans
- Health authority responses
- Briefing documents, ODDs, BTDs/PRIME, FTD, and similar designations
- Review, edit, and QC documents developed by other authors or medical writers
- Manage the author, review, and approval process for multiple deliverables at a given time; ensure quality and timely completion, with attention to consistency of content, messaging, format, and style
- Lead Regulatory & Medical Writing activities for assigned programs, including partnering with the Head of Regulatory & Medical Writing on resource planning, document timelines, issue resolution, and process improvement initiatives
- Represent Regulatory & Medical Writing on interdisciplinary teams for assigned programs/projects, providing strategic input and status updates
- Manage external Regulatory & Medical Writing resources for assigned programs/projects, as needed
WHAT YOU’LL BRING
- 6 to 8+ years of Regulatory and/or Medical Writing, or other relevant pharmaceutical/biotechnology industry experience in the Clinical Development phase, authoring and overseeing documents submitted to health authorities
- Experience identifying and interpreting information/data for inclusion in documents such as clinical study protocols, Investigator’s Brochures, clinical study reports, Lay Summaries, and ICFs
- Involvement with ex-US submissions for clinical trial applications and marketing applications is a plus
- Ability to work effectively and lead in cross-functional working groups
- Excellent communication skills, organizational skills, and attention to detail
- Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
- Knowledge of health authority requirements, ICH guidelines, and submission-ready standards relevant to document authoring, including eCTD and submission lifecycle management
- Proficiency in project planning tools such as MS Project or Smartsheet, collaborative authoring or document review tools, and Veeva RIM Suite
- Expertise in Microsoft Word (including use of customized toolbars/templates) and document management systems
SALARY RANGE
- Salary Range: $216,400 - $234,800
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate’s relevant experience, technical expertise, and how their background aligns with the role’s requirements.
LOCATION
Location: Onsite – Brisbane, CA
FIT WITH NURIX CULTURE AND VALUES
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view
ABOUT NURIX THERAPEUTICS
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
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Senior Level Associate Director Medical Writing Jobs: Frequently Asked Questions
How do I get a senior level associate director medical writing job?
Employers at this level look for candidates who have owned complex regulatory submissions end to end, such as NDAs, BLAs, or CTDs, and who have mentored or managed junior writers. Demonstrating cross-functional leadership, a deep grasp of ICH guidelines, and the ability to set quality standards across a document suite gives candidates the strongest edge at the associate director level.
Which companies hire senior level associate director medical writings?
Companies hiring senior level associate director medical writings right now include Alkermes, Incyte Corporation, and Nurix Therapeutics, based on current listings on Migrate Mate as of October 2026. Hiring at this level is concentrated among large pharmaceutical manufacturers, contract research organizations, and mid-size biotech firms with active regulatory pipelines.
Are there remote senior level associate director medical writing jobs?
Yes, remote and hybrid options are widely available at this level. About 50% of senior level associate director medical writing openings are remote or hybrid as of October 2026, reflecting how established this role is in distributed work models. Fully on-site roles do exist, typically at sponsors with on-campus regulatory teams or roles tied to lab-facing submissions.
What makes an associate director medical writing role senior level?
Senior level roles are defined by strategic ownership rather than individual contribution. At this stage, you are accountable for document quality across an entire program or therapeutic area, set writing standards and processes, and lead or mentor a team of writers. You are also expected to partner directly with regulatory affairs, clinical, and biostatistics leadership to shape submission strategy.
Which industries hire the most senior level associate director medical writings?
Senior level associate director medical writing roles concentrate in Biotechnology & Pharmaceuticals and Healthcare & Medical Services, based on current listings on Migrate Mate as of October 2026. These sectors drive hiring at this level because they carry the highest volume of regulatory submissions and require seasoned writers who can own complex, high-stakes documents from first draft through agency review.