H-1B Visa Medical Writer Jobs
Medical Writer roles qualify for H-1B sponsorship as specialty occupations requiring at least a bachelor's degree in a directly related field. Pharmaceutical, biotech, and medical device companies regularly file LCAs for these positions. Cap-subject H-1B registration opens each March, with an October 1 start date if selected.
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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 127+ Medical Writer jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Medical Writer
Align your degree to the SOC code
USCIS scrutinizes whether your degree field directly relates to medical writing. A degree in pharmacy, life sciences, or health communications strengthens your petition. A general English degree with no science coursework can trigger an RFE.
Check prevailing wages before negotiating
Use the OFLC Wage Search to look up the prevailing wage for Medical Writers under SOC code 27-3042 in your work location. Your offered salary must meet at least Level I for the LCA to be certified by DOL.
Target companies with active LCA filing history
Pharmaceutical companies, CROs, and medical communications agencies file LCAs regularly for medical writing roles. Use Migrate Mate to filter employers by verified H-1B filing history so you're applying where sponsorship is already established.
Prepare a regulatory writing portfolio early
Employers sponsoring H-1B petitions for medical writers often need to justify the specialty occupation requirement to USCIS. Documented experience with FDA submissions, clinical study reports, or IND packages strengthens both your application and the employer's petition.
Understand how therapeutic area affects sponsorship
Medical writing roles in oncology, rare disease, and late-phase regulatory submissions are more likely to receive premium processing from employers because delays cost significantly more. Targeting these therapeutic areas can improve your odds of a faster H-1B timeline.
Medical Writer jobs are hiring across the US. Find yours.
Find Medical Writer JobsMedical Writer H-1B Visa: Frequently Asked Questions
Does a Medical Writer role qualify as a specialty occupation for H-1B purposes?
Yes, medical writing qualifies as a specialty occupation when the position requires at least a bachelor's degree in a directly related field such as pharmacy, life sciences, nursing, or health communications. USCIS evaluates the specific job duties and degree requirement on a case-by-case basis. Roles focused on FDA regulatory submissions or clinical documentation tend to have the clearest specialty occupation case.
Which types of employers sponsor H-1B visas for Medical Writers?
Pharmaceutical companies, biotechnology firms, medical device manufacturers, contract research organizations, and medical communications agencies are the most consistent sponsors for medical writing roles. These employers file LCAs with DOL regularly and have internal immigration counsel or retained law firms experienced with H-1B petitions. You can browse employers with verified H-1B filing history for medical writing roles on Migrate Mate.
Can my medical writing work experience substitute for a degree on an H-1B petition?
USCIS allows three years of specialized experience to substitute for one year of a bachelor's degree, but this only applies when the employer's job posting does not require a degree. If the position requires a bachelor's degree in a specific field, experience alone won't satisfy the specialty occupation requirement. Your employer's attorney will need to document the equivalency carefully with a credential evaluation if experience is being used.
Does the O*NET classification for Medical Writers affect my H-1B petition?
The O*NET occupation profile for Writers and Authors (SOC 27-3042) is the DOL classification most commonly used for medical writers. It informs the prevailing wage level the employer must certify on the LCA. Some employers use a more specific title under a different SOC code depending on the role's focus, such as a technical or scientific writer classification, which can affect the wage level.
What happens to my H-1B status if my medical writing contract ends early?
If your employer terminates your H-1B employment before the petition end date, they are legally required to pay for your return transportation home. You have a 60-day grace period to find a new sponsoring employer, change status, or depart. If a new employer files an H-1B transfer petition while you're still in that 60-day window, you can begin work once the receipt notice is issued under portability rules.
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