Director Medical Writing Jobs in USA with Visa Sponsorship
Director of Medical Writing roles frequently qualify for H-1B visa and O-1 visa sponsorship, given the advanced scientific and regulatory expertise required. Most positions demand a graduate degree in life sciences or a related field, making specialty occupation classification straightforward for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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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+ Director Medical Writing Jobs
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Get Access To All JobsTips for Finding Director Medical Writing Jobs
Lead with your regulatory writing credentials
Employers sponsoring a Director of Medical Writing want evidence of hands-on NDA, BLA, or IND submission experience. Highlight specific regulatory documents you've authored or led to strengthen the specialty occupation argument in your H-1B petition.
Emphasize your advanced degree match
H-1B specialty occupation requires a directly related degree. A master's or PhD in pharmacology, biochemistry, or a clinical field maps cleanly. If your undergraduate degree is in a different discipline, document how graduate coursework bridges the gap.
Target biotech and pharma companies with established immigration programs
Large pharmaceutical companies and mid-size biotechs routinely sponsor senior scientific roles. Employers with dedicated HR immigration teams process petitions faster and with fewer complications than those filing for the first time.
Consider the O-1A if you have a publication or leadership record
Directors with published research, regulatory guidance contributions, or speaking history at major medical conferences may qualify for the O-1A. This visa bypasses the H-1B lottery entirely and is worth discussing with an immigration attorney.
Clarify the managerial versus technical scope of the role
USCIS scrutinizes director-level titles more heavily. Ensure your job offer letter clearly describes the specialized scientific judgment required, not just team oversight. A role defined primarily by technical expertise supports specialty occupation more strongly.
Ask about in-house immigration counsel before accepting an offer
Companies with in-house immigration attorneys or preferred outside counsel process H-1B petitions more reliably. Confirming this before accepting an offer reduces delays and gives you a clearer timeline from petition filing to start date.
Frequently Asked Questions
Does Director of Medical Writing qualify as a specialty occupation for H-1B purposes?
Yes. Director of Medical Writing consistently qualifies as an H-1B visa specialty occupation because the role requires a bachelor's degree or higher in a specific scientific or technical field, such as pharmacology, biochemistry, or life sciences. USCIS expects a direct relationship between the degree field and the regulatory, clinical, and scientific writing tasks the role demands. Director-level positions with significant managerial duties should include a detailed job description emphasizing the specialized knowledge required.
What degree do I need to get H-1B sponsorship as a Director of Medical Writing?
Most employers require at least a bachelor's degree in a life science, pharmacy, or health-related field, and many prefer a master's or PhD. The degree must relate specifically to the work, not just to writing in general. A degree in English or communications alone is unlikely to support an H-1B petition for this role. If your undergraduate degree is in a different field, a graduate degree in pharmacology, clinical research, or regulatory affairs typically resolves the specialty occupation requirement.
Are Director of Medical Writing jobs commonly sponsoring visas in 2025?
Yes. Pharmaceutical companies, contract research organizations, and biotechs regularly sponsor senior medical writing roles because qualified candidates are scarce and the regulatory expertise required is highly specialized. You can browse currently available sponsored Director of Medical Writing positions on Migrate Mate, which filters specifically for roles open to visa sponsorship so you're not wasting applications on companies that won't file.
Can I qualify for an O-1A visa as a Director of Medical Writing?
Possibly, depending on your record. The O-1A requires extraordinary ability demonstrated through peer-reviewed publications, regulatory guidance contributions, judging others' work, or critical roles at distinguished organizations. Senior medical writers who have authored widely cited clinical study reports, contributed to FDA guidance documents, or held leadership roles in organizations like AMWA or DIA may meet the threshold. An immigration attorney can assess whether your profile clears the bar before you pursue this path.
How does the H-1B lottery affect my chances of getting sponsored as a Director of Medical Writing?
The standard H-1B lottery applies unless your employer qualifies as a cap-exempt institution, such as a university medical center or nonprofit research organization. In FY 2025, USCIS received roughly 442,000 registrations for 85,000 available slots, producing a selection rate around 25%. If you're not selected, options include reapplying the following year, exploring cap-exempt employers, or assessing O-1A eligibility. Some employers will also explore the TN visa for Canadian or Mexican nationals with qualifying credentials.
What is the prevailing wage requirement for sponsored 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.