H-1B Visa Director Medical Writing Jobs
Director Medical Writing roles qualify as H-1B visa specialty occupations, requiring at least a bachelor's degree in a life sciences or related field. Large pharmaceutical, biotech, and CRO employers regularly sponsor H-1B petitions for this title, and the role's regulatory documentation requirements make it a strong fit for prevailing wage Level III or IV classifications.
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Get Access To All JobsINTRODUCTION
The Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives.
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
BASIC QUALIFICATIONS
- Degree Level: PhD
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
INTRODUCTION
The Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing expertise with responsibilities for resource planning and matrix leadership to deliver high-quality, fit-for-purpose clinical and regulatory documents aligned with program and regulatory objectives. The Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. The Director applies advanced technical judgment to solve complex problems and ensures Medical Writing activities are integrated with broader development and regulatory objectives.
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
BASIC QUALIFICATIONS
- Degree Level: PhD
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Director Medical Writing
Align your credentials to specialty occupation standards
Your degree must directly relate to medical writing, not just science broadly. A degree in pharmacy, biochemistry, or regulatory affairs strengthens the specialty occupation argument more than a general biology degree paired with work experience alone.
Target pharmaceutical and CRO employers with H-1B history
Use Migrate Mate to filter Director Medical Writing roles by employers who have filed H-1B Labor Condition Applications for this job title, so you're only pursuing companies with a demonstrated sponsorship track record.
Verify prevailing wage level before accepting an offer
Run the OFLC Wage Search using the SOC code for Medical Scientists or Technical Writers before negotiating. Directors typically fall at Level III or IV, and an offer below that threshold forces the employer to revise the LCA before filing.
Check whether your employer qualifies as H-1B dependent
Employers with a high ratio of H-1B workers to total staff face stricter attestation requirements under the H-1B dependent employer rules. Ask HR directly during the offer stage, as this affects your petition timeline and the employer's obligations to recruit U.S. workers first.
Secure an O*NET classification review for your job description
Director Medical Writing doesn't map to a single O*NET code, so your employer's LCA may reference Medical Scientists or Technical Writers. Request a copy of the job description used for the LCA and confirm the duties match your actual role to avoid an RFE on specialty occupation grounds.
Plan around the October 1 start date when changing employers
If you're transferring an H-1B to a new employer mid-year, portability under AC21 lets you start work once the transfer petition is filed, not approved. Confirm your new employer files before your current authorized period ends so you don't create a gap in status.
H-1B Visa Director Medical Writing: Frequently Asked Questions
Does a Director Medical Writing role qualify as an H-1B specialty occupation?
Yes. USCIS evaluates specialty occupation status based on whether the role normally requires at least a bachelor's degree in a specific field. Director Medical Writing meets this standard because the position requires specialized knowledge in regulatory science, clinical data interpretation, or a related life sciences discipline. Your employer will document this in the I-129 petition using the job description and industry norms.
Which employers sponsor H-1B visas for Director Medical Writing positions?
Pharmaceutical companies, contract research organizations, and biotech firms are the most consistent H-1B sponsors for this title. You can browse Director Medical Writing roles filtered by verified LCA filing history on Migrate Mate, which pulls directly from DOL disclosure data so you're targeting employers who have already sponsored this job category.
How does prevailing wage apply to a Director-level medical writing role?
The DOL requires H-1B employers to pay at least the prevailing wage for the occupation and geographic location listed on the LCA. At Director level, most petitions are certified at wage Level III or Level IV under the OFLC Wage Search system. Your employer must meet or exceed that threshold from your first day in H-1B status, not just at hire.
Can I change employers if my H-1B is already approved for a medical writing role?
Yes, through H-1B portability under AC21, you can transfer to a new employer in a same or similar occupational classification once your new employer files an H-1B transfer petition. For Director Medical Writing, same or similar generally means the new role involves comparable regulatory or scientific writing responsibilities. You can start working for the new employer as soon as the transfer petition is received by USCIS.
Does the H-1B cap apply to Director Medical Writing positions?
Most private-sector medical writing positions are subject to the annual H-1B cap and lottery, which covers 85,000 new H-1B visas per fiscal year. Cap-exempt status applies only if your employer is a nonprofit research institution, university, or affiliated entity. Standard pharmaceutical and CRO employers are cap-subject, so timing your job search around the annual registration period each March is essential.