Senior Level Director Medical Writing Jobs
Senior level director medical writing jobs place experienced professionals in charge of regulatory strategy, submission quality, and the cross-functional teams that deliver complex clinical and medical documents. Roles are predominantly remote and hybrid across Biotechnology & Pharmaceuticals and Healthcare & Medical Services, with 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 Director Medical Writing Jobs: Frequently Asked Questions
How do I get a senior level director medical writing job?
Employers at this level expect a demonstrated history of leading regulatory submissions, managing or mentoring writing teams, and owning document strategy across complex programs. Candidates who stand out pair deep therapeutic area expertise with the ability to influence cross-functional stakeholders and drive process improvements. Tailoring your application to show scope of ownership, not just output, makes the clearest impression.
Which companies hire senior level director medical writings?
Companies hiring senior level 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 and biotechnology firms, contract research organizations, and medical communications agencies managing high-volume regulatory programs.
Are there remote senior level director medical writing jobs?
Yes, remote and hybrid arrangements are common at this level given the document-centric nature of the work. About 50% of senior level director medical writing openings are remote or hybrid as of October 2026, reflecting how broadly the industry has adopted flexible work models for experienced regulatory writing professionals.
What makes a director medical writing role senior level?
Senior level director medical writing roles are defined by ownership rather than execution. Professionals at this stage set documentation standards, lead or mentor teams of writers, oversee multiple submission tracks simultaneously, and serve as the primary regulatory writing voice in cross-functional planning. The expectation shifts from producing high-quality documents to ensuring an entire program's written output meets strategic and compliance goals.
Which industries hire the most senior level director medical writings?
Senior Level 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 demand because their regulatory pipelines require sustained, expert-level oversight of submissions, clinical study reports, and agency communications throughout the product lifecycle.