H-1B Visa Senior Medical Writer Jobs
Senior Medical Writer roles qualify as H-1B specialty occupations under the life sciences and communications fields, requiring at least a bachelor's degree in a relevant discipline. Employers in pharma, biotech, CROs, and medical communications agencies regularly sponsor H-1B visas for this title, with cap-subject filings due each April for an October 1 start.
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Get Access To All JobsWork Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
We are seeking a talented and experienced Senior Medical Writer to join our team in NA. The SMW will support our FSP business; experience in EU CTR and early development would be preferred. The Senior Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards.
Key Responsibilities:
- Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
- Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.
- Ensure documents align with regulatory guidelines, company standards, and industry best practices.
- Provide input on document content, structure, and presentation.
- Review and provide feedback on documents prepared by other team members.
- Manage timelines and deliverables for assigned projects.
- Stay current with industry trends, guidelines, and regulatory requirements.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.
5+ years regulatory writing experience.
Experience working in the pharmaceutical/CRO industry required.
Experience in managing and directing complex medical writing projects required.
EU CTR and early development experience preferred.
Knowledge, Skills, and Abilities:
- Excellent organizational and program management skills
- Proven leadership skills to manage and mentor a team of medical writers.
- Extensive knowledge of regulatory guidelines and drug development processes
- Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders
- Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
- Self-motivated and adaptable
- Excellent judgment; high degree of independence in decision making and problem solving
What We Offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
We are seeking a talented and experienced Senior Medical Writer to join our team in NA. The SMW will support our FSP business; experience in EU CTR and early development would be preferred. The Senior Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards.
Key Responsibilities:
- Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.
- Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.
- Ensure documents align with regulatory guidelines, company standards, and industry best practices.
- Provide input on document content, structure, and presentation.
- Review and provide feedback on documents prepared by other team members.
- Manage timelines and deliverables for assigned projects.
- Stay current with industry trends, guidelines, and regulatory requirements.
Education and Experience:
Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred.
5+ years regulatory writing experience.
Experience working in the pharmaceutical/CRO industry required.
Experience in managing and directing complex medical writing projects required.
EU CTR and early development experience preferred.
Knowledge, Skills, and Abilities:
- Excellent organizational and program management skills
- Proven leadership skills to manage and mentor a team of medical writers.
- Extensive knowledge of regulatory guidelines and drug development processes
- Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders
- Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
- Self-motivated and adaptable
- Excellent judgment; high degree of independence in decision making and problem solving
What We Offer:
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
See all 96+ Senior Medical Writer jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Senior Medical Writer roles.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Senior Medical Writer
Align your degree to the role
USCIS requires your degree field to directly relate to medical writing. A degree in pharmacy, biology, biochemistry, or scientific communications strengthens your specialty occupation argument. A general English or communications degree alone may trigger an RFE.
Target CROs and medical communications agencies
Contract research organizations and med comms agencies file H-1B petitions routinely for writers producing regulatory documents, clinical study reports, and manuscripts. These employers have established sponsorship workflows, reducing your onboarding friction compared to first-time sponsors.
Search verified H-1B sponsors on Migrate Mate
Use Migrate Mate to filter Senior Medical Writer openings by employers with confirmed H-1B LCA filing history in your SOC code. This cuts out roles where sponsorship is speculative and surfaces companies that have sponsored writers before.
Check prevailing wage before salary negotiations
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your location and job level. Run the OFLC Wage Search using SOC code 27-3042 before accepting an offer so you know the floor your employer must meet.
Confirm regulatory writing counts as your core duty
USCIS scrutinizes whether the role genuinely requires a specialized degree rather than general writing ability. Roles centered on IND, NDA, or BLA submissions, clinical protocols, or ICH-compliant documents carry stronger specialty occupation support than general content or marketing writing.
Request premium processing if your start date is fixed
If your employer needs you in a specific trial phase or submission window, ask them to file Form I-907 for premium processing. USCIS adjudicates premium H-1B petitions within 15 business days, giving both sides certainty before a hard project deadline.
Senior Medical Writer jobs are hiring across the US. Find yours.
Find Senior Medical Writer JobsSenior Medical Writer H-1B Visa: Frequently Asked Questions
Does a Senior Medical Writer role qualify as an H-1B specialty occupation?
Yes. USCIS treats Senior Medical Writer as a specialty occupation when the position requires at least a bachelor's degree in a field directly related to the work, such as pharmacy, biochemistry, life sciences, or scientific communications. Roles focused on regulatory submissions, clinical study reports, or labeling documents have the strongest case because the subject matter demands specialized scientific training, not general writing skill.
Which employers sponsor H-1B visas for Senior Medical Writers?
Pharmaceutical companies, biotechs, contract research organizations, and dedicated medical communications agencies are the most consistent H-1B sponsors for this title. These organizations file LCAs regularly for writers working on regulatory documents, manuscripts, and clinical trial materials. You can find employers with verified H-1B filing history in this occupation on Migrate Mate, so you're applying to roles where sponsorship is already established rather than negotiating it from scratch.
Can my employer sponsor my H-1B if they have no prior sponsorship experience?
Yes, but the process takes more preparation on their end. A first-time sponsor must register with E-Verify, file the LCA with DOL for certification, and then submit the H-1B petition to USCIS. Many pharma and biotech companies have HR or legal teams experienced with this process, but smaller medical communications agencies may need outside immigration counsel, which can affect your offer timeline.
What happens to my H-1B status if my employer changes the scope of my medical writing role?
A material change in job duties, work location, or employment terms may require an amended H-1B petition before the change takes effect. If your role shifts from regulatory writing to a broader communications or marketing function, USCIS could view it as a different position. Your employer should file an amendment and a new LCA if duties, title, or work site change substantially, rather than waiting until renewal.
How does the H-1B cap lottery affect my job search timeline as a Senior Medical Writer?
Cap-subject H-1B petitions are filed in April for an October 1 start, so you need a job offer and completed registration by late March. If you're on OPT or another status, timing your job search to land an offer by February or early March gives your employer enough runway. Cap-exempt employers, such as nonprofit research institutions or certain hospitals, can file year-round, which removes the lottery constraint entirely.
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