Associate Director Medical Writing Jobs in USA with Visa Sponsorship
Associate Director Medical Writing roles attract strong H-1B visa sponsorship from pharmaceutical, biotech, and CRO employers. Most require an advanced degree in life sciences and 8-plus years of regulatory writing experience. Demand is consistent across major biopharma hubs including Boston, San Francisco, and New Jersey.
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Get Access To All JobsINTRODUCTION
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.
See all 75+ Associate Director Medical Writing Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Associate Director Medical Writing roles.
Get Access To All JobsTips for Finding Associate Director Medical Writing Jobs
Target large pharma and CRO employers first
Large pharmaceutical companies and contract research organizations file H-1B petitions at high volume and have established immigration infrastructure. They're far more likely to sponsor senior medical writing roles than small biotech startups with limited legal resources.
Highlight regulatory submission experience prominently
Employers sponsoring at the Associate Director level want evidence you can lead NDA, BLA, or IND submissions. Listing specific document types you've authored, such as clinical study reports or briefing documents, strengthens both your application and the specialty occupation case.
Confirm your degree field aligns with the role
H-1B specialty occupation requires a directly related degree. Life sciences, pharmacy, medicine, or scientific writing are strong fits. A degree in an unrelated field, even with years of experience, can complicate USCIS adjudication and increase the risk of an RFE.
Ask about sponsorship policy before the final interview round
Some employers sponsor only after an internal transfer threshold. Raise visa sponsorship early, ideally after an initial screening call, so you don't invest multiple interview rounds with a company that won't file for your category or seniority level.
Understand the H-1B lottery timing relative to your start date
If you need a new H-1B, registration opens in March for an October 1 start. If your current status allows cap-exempt filing, such as through a university or nonprofit, discuss that option with your employer to avoid a six-month wait.
Use Migrate Mate to filter for verified sponsoring employers
Many job listings don't state sponsorship availability upfront. Migrate Mate surfaces Associate Director Medical Writing roles from employers with confirmed sponsorship history, saving you from applying to positions that won't move forward due to visa constraints.
Frequently Asked Questions
Do Associate Director Medical Writing roles commonly get H-1B sponsorship?
Yes. At the Associate Director level, employers are investing in senior leadership and are generally willing to sponsor H-1B visas. Large pharma companies such as Pfizer, AstraZeneca, and Merck, along with major CROs like Covance and ICON, have consistent sponsorship track records for this title. Smaller biotechs vary significantly, so it's worth confirming their policy before applying.
What degree do I need for an Associate Director Medical Writing position?
Most employers require at least a bachelor's degree in a life sciences field, with a preference for advanced degrees such as a PharmD, PhD, or master's in pharmacology, biology, or a related discipline. The degree must relate directly to the role to satisfy H-1B specialty occupation requirements. USCIS will scrutinize the connection between your field of study and the specific writing responsibilities.
Will I face H-1B RFEs at the Associate Director level?
RFEs are possible but less common for senior roles with clearly defined specialty occupation requirements. USCIS is more likely to issue an RFE if the job description includes broad managerial duties that don't exclusively require a specialized degree. A well-drafted petition that ties regulatory writing responsibilities to your specific academic background reduces this risk substantially.
Can I change employers on an H-1B while working as an Associate Director Medical Writing?
Yes, H-1B portability allows you to start with a new employer once they file the transfer petition, without waiting for approval, provided your current H-1B was lawfully approved and you've maintained status. Your new employer must file a cap-exempt H-1B transfer petition before you begin work. Migrate Mate lists roles from employers already set up to handle this process.
Is O-1A a realistic alternative to H-1B for this role?
It can be, particularly if you have published research, peer review credits, conference presentations, or have held roles at organizations with distinguished reputations in the field. Associate Directors with substantial publication records or recognized regulatory contributions sometimes qualify. O-1A has no lottery and no annual cap, making it worth evaluating with an immigration attorney if H-1B selection is a concern.
What is the prevailing wage requirement for sponsored Associate Director Medical Writing jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.