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 JobsLooking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.
Remote
Employee Value Proposition:
At Taiho Oncology, we are driven by our mission to improve the lives of cancer patients. As an Associate Director, Medical Writing, you will work on various document types and play a critical role in transforming scientific data into compelling narratives that contribute to innovative cancer treatments. Join a dedicated team that fosters a collaborative, patient-first environment, where your expertise and passion will directly impact patient care and advance oncology research. We believe in empowering our employees through continuous learning, career development, and a supportive culture that values diverse perspectives and encourages innovation. If you are ready to take on new challenges and make a meaningful difference, Taiho Oncology offers you the opportunity to grow, excel, and be a part of something bigger. Together, we are relentless in our pursuit of better cancer treatments. Join us in putting patients at the heart of everything we do.
Position Summary:
The incumbent is responsible for authoring Taiho Oncology, Inc., (TOI), documents submitted to Regulatory Authorities including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and relevant summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions for drugs in line with regulatory requirements and internal standard operating procedures.
Performance Objectives:
- Responsible for authoring TOI documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.
- Prepare documents in line with regulatory requirements in conjunction with Regulatory Affairs and with internal standard operating procedures in a timely and accurate manner.
- Understand publishing standards for FDA and MAA.
- Manages and oversees medical writing deliverables assigned to internal and contract writers or other third party vendors.
- Represent Global Medical Writing department on clinical development cross-functional teams and project initiatives.
- Develop and implement medical writing processes in line with SOPs.
- Prepares project and/or status reports.
- Proficient in Microsoft applications and document management systems.
Education/Certification Requirements:
- Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
Knowledge, Skills, and Abilities:
- Minimum of 8 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
- Extensive previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
- Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
- Knowledge of template development, document management systems and requirements.
- Experience developing and implementing medical writing processes for all stages of clinical development.
- Strong working knowledge of medical writing requirements and document components.
- Good interpersonal skills that involves working well in a team environment and the ability to lead others.
- Good organizational and planning skills; drive for results.
- Ability to read, analyze and interpret scientific and technical information.
- Effective analytical/problem solving skills.
The pay range for this position at commencement of employment is expected to be between $194,650 - $229,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
LI-Remote
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.
Remote
Employee Value Proposition:
At Taiho Oncology, we are driven by our mission to improve the lives of cancer patients. As an Associate Director, Medical Writing, you will work on various document types and play a critical role in transforming scientific data into compelling narratives that contribute to innovative cancer treatments. Join a dedicated team that fosters a collaborative, patient-first environment, where your expertise and passion will directly impact patient care and advance oncology research. We believe in empowering our employees through continuous learning, career development, and a supportive culture that values diverse perspectives and encourages innovation. If you are ready to take on new challenges and make a meaningful difference, Taiho Oncology offers you the opportunity to grow, excel, and be a part of something bigger. Together, we are relentless in our pursuit of better cancer treatments. Join us in putting patients at the heart of everything we do.
Position Summary:
The incumbent is responsible for authoring Taiho Oncology, Inc., (TOI), documents submitted to Regulatory Authorities including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and relevant summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions for drugs in line with regulatory requirements and internal standard operating procedures.
Performance Objectives:
- Responsible for authoring TOI documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.
- Prepare documents in line with regulatory requirements in conjunction with Regulatory Affairs and with internal standard operating procedures in a timely and accurate manner.
- Understand publishing standards for FDA and MAA.
- Manages and oversees medical writing deliverables assigned to internal and contract writers or other third party vendors.
- Represent Global Medical Writing department on clinical development cross-functional teams and project initiatives.
- Develop and implement medical writing processes in line with SOPs.
- Prepares project and/or status reports.
- Proficient in Microsoft applications and document management systems.
Education/Certification Requirements:
- Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
Knowledge, Skills, and Abilities:
- Minimum of 8 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
- Extensive previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
- Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
- Knowledge of template development, document management systems and requirements.
- Experience developing and implementing medical writing processes for all stages of clinical development.
- Strong working knowledge of medical writing requirements and document components.
- Good interpersonal skills that involves working well in a team environment and the ability to lead others.
- Good organizational and planning skills; drive for results.
- Ability to read, analyze and interpret scientific and technical information.
- Effective analytical/problem solving skills.
The pay range for this position at commencement of employment is expected to be between $194,650 - $229,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
LI-Remote
Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties, as assigned.
See all 12+ Director Medical Writing jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Director Medical Writing roles.
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.
Director Medical Writing jobs are hiring across the US. Find yours.
Find Director Medical Writing JobsFrequently 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 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.
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