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.
See All Associate Director Medical Writing JobsOverview
Showing 5 of 8+ Associate Director Medical Writing jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 8+ 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 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 8+ 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.
Associate Director Medical Writing jobs are hiring across the US. Find yours.
Find Associate Director Medical Writing JobsFrequently 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.
See which Associate Director Medical Writing employers are hiring and sponsoring visas right now.
Search Associate Director Medical Writing Jobs