Medical Writer Jobs in USA with Visa Sponsorship
Medical writers in the U.S. typically qualify for H-1B visa or O-1 visa sponsorship, as the role meets the specialty occupation standard through its requirement for a bachelor's degree or higher in a life science, pharmacy, or related field. Employers in pharma, biotech, and CROs sponsor regularly. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsJob title: Senior Medical Writer - Vaccine
Location: Swiftwater, PA
About the Job
The Senior Medical Writer is a member of the Clinical Team. He/she is responsible for the production of key documents related to Clinical Department and Global Medical Affairs activities (e.g., concept documents, protocol, CSR, IBs, Informed Consent Forms, expert reports/integrated summaries, CTD Modules 2 and 5, etc.) in line with the Company as well as external standards, e.g., regulatory requirements or guidelines.
The Medical Writing platform is within Clinical Programs. The Medical Writer reports to the Local Head of Medical Writing for mentoring, appraisal and training. He/she may be the representative of his/her function in one or several clinical teams according to the number of projects he/she has to manage. In this case, he/she is accountable to the Clinical Team Leader for all project issues.
The Medical Writer is a member of one or more clinical teams according to the projects he/she has been assigned. His/her role is to be the referent for his/her function within the team. He/she will be responsible for coordinating the writing of major documents to conduct trials of the projects. He/she has to work in close collaboration with other functions/members of the clinical team to achieve the correct writing of documents.
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
- Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs
- Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs.
- Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department
- Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer)
- Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF)
- Contributes to the development of document templates and relevant SOPs. Represents the platform on committees and working groups within Clinical as requested
- Provides mentoring support to less experienced colleagues and new Company staff members if needed
- Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing
- Is in charge of supervising subcontracted medical writing activities if needed.
- May contribute to the updates of templates, SOPs, and other guides for Medical Writing.
About You
Basic Qualifications:
- Advanced degree in Life Sciences or related field of study.
- 3 or + years of clinical and regulatory medical writing experience within a pharmaceutical company or clinical research organization (CRO).
- Fluent English communication skills, verbal and written.
- Professional background documenting an excellent understanding of and experience in clinical development including clinical study performance/methodology/ basic statistics and/or the regulatory environment.
- Demonstrated strong interpersonal, time management and technical writing skills.
- Excellent word-processing skills and experience with electronic document templates are required and other relevant applications (eg, Excel, Outlook, EndNote, Read Cube, Please Review).
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.
- Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.
- Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
GD-SP
LI-SP
LI-Remote
vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job title: Senior Medical Writer - Vaccine
Location: Swiftwater, PA
About the Job
The Senior Medical Writer is a member of the Clinical Team. He/she is responsible for the production of key documents related to Clinical Department and Global Medical Affairs activities (e.g., concept documents, protocol, CSR, IBs, Informed Consent Forms, expert reports/integrated summaries, CTD Modules 2 and 5, etc.) in line with the Company as well as external standards, e.g., regulatory requirements or guidelines.
The Medical Writing platform is within Clinical Programs. The Medical Writer reports to the Local Head of Medical Writing for mentoring, appraisal and training. He/she may be the representative of his/her function in one or several clinical teams according to the number of projects he/she has to manage. In this case, he/she is accountable to the Clinical Team Leader for all project issues.
The Medical Writer is a member of one or more clinical teams according to the projects he/she has been assigned. His/her role is to be the referent for his/her function within the team. He/she will be responsible for coordinating the writing of major documents to conduct trials of the projects. He/she has to work in close collaboration with other functions/members of the clinical team to achieve the correct writing of documents.
Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI-driven breakthroughs. In Vaccines, you'll help advance prevention on a global scale - and shape the future of immunization.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
- Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs
- Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs.
- Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department
- Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer)
- Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF)
- Contributes to the development of document templates and relevant SOPs. Represents the platform on committees and working groups within Clinical as requested
- Provides mentoring support to less experienced colleagues and new Company staff members if needed
- Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing
- Is in charge of supervising subcontracted medical writing activities if needed.
- May contribute to the updates of templates, SOPs, and other guides for Medical Writing.
About You
Basic Qualifications:
- Advanced degree in Life Sciences or related field of study.
- 3 or + years of clinical and regulatory medical writing experience within a pharmaceutical company or clinical research organization (CRO).
- Fluent English communication skills, verbal and written.
- Professional background documenting an excellent understanding of and experience in clinical development including clinical study performance/methodology/ basic statistics and/or the regulatory environment.
- Demonstrated strong interpersonal, time management and technical writing skills.
- Excellent word-processing skills and experience with electronic document templates are required and other relevant applications (eg, Excel, Outlook, EndNote, Read Cube, Please Review).
Why Choose Us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.
- Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.
- Develop your career with access to mentoring, international mobility programs, and opportunities to grow across four continents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
GD-SP
LI-SP
LI-Remote
vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
See all 382+ Medical Writer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Medical Writer roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Medical Writer
Target pharma, biotech, and CRO employers
Contract research organizations, pharmaceutical companies, and biotechnology firms are the most consistent sponsors for medical writers. These employers file H-1B petitions regularly and have established immigration infrastructure, making the sponsorship process faster and more predictable for candidates.
Confirm your degree field satisfies specialty occupation
USCIS requires a direct relationship between your degree field and the medical writing role. Degrees in life sciences, pharmacy, nursing, or biomedical science are strong fits. A general science or unrelated degree may require additional documentation to establish the specialty occupation connection.
Highlight regulatory writing experience in your application
Employers sponsoring medical writers are often motivated by specialized skills in regulatory submissions, clinical study reports, or FDA documentation. Candidates with this background are harder to replace locally, which strengthens the business justification employers need to pursue sponsorship.
Ask about sponsorship policy before the offer stage
Some employers support H-1B sponsorship but restrict it to direct hires rather than contractors. Clarifying this early prevents wasted time on roles that look promising but won't result in visa support. Filter for roles explicitly listing sponsorship on Migrate Mate to avoid this problem.
Understand the H-1B lottery timeline before you apply
H-1B registration opens each March for an October start date. If you need status by a specific date due to OPT expiration or a grace period, work backwards from that deadline and communicate your timeline to potential employers during the interview process.
Consider O-1A if your publication record is strong
Medical writers with peer-reviewed publications, editorial board roles, or recognized contributions to clinical guidelines may qualify for the O-1A visa. It has no annual cap or lottery, making it a viable alternative when H-1B timing or selection odds are a concern.
Frequently Asked Questions
Do medical writer jobs in the U.S. qualify for H-1B visa sponsorship?
Yes, medical writing qualifies as a specialty occupation because the role typically requires a bachelor's degree or higher in a specific field such as life sciences, pharmacy, or a related discipline. USCIS has approved H-1B visa petitions for medical writers at pharmaceutical companies, CROs, and medical communications agencies. The strength of your petition depends on how clearly the job description establishes that a specific degree is a minimum requirement, not merely preferred.
What degree do I need to get a medical writing job sponsored in the U.S.?
Most employers require at least a bachelor's degree in a life science field, pharmacy, nursing, biomedical science, or a closely related discipline. Advanced degrees, such as a master's or Ph.D. in pharmacology or a clinical field, are common in regulatory medical writing roles and strengthen both your candidacy and the H-1B petition. A general science or humanities degree may still qualify if you can demonstrate field-specific coursework or equivalent experience, but expect more scrutiny from USCIS.
Which types of employers sponsor medical writers for U.S. visas?
Pharmaceutical companies such as Pfizer, Johnson & Johnson, and AstraZeneca, large contract research organizations, and medical communications agencies are the most active sponsors. Biotech startups also sponsor but vary widely in their immigration experience and resources. Browsing open roles on Migrate Mate lets you filter specifically for positions that offer visa sponsorship, so you can focus your applications on employers already open to the process.
Can a medical writer on OPT get sponsored before it expires?
Yes, but timing is critical. H-1B registration opens in March each year, with an October 1 start date if selected. If your OPT expires before October 1, you'll need a STEM OPT extension to bridge the gap, which requires a STEM-eligible degree. Start conversations with employers about sponsorship at least four to six months before your OPT ends to allow enough runway for the process.
Is it possible to get sponsored as a freelance or contract medical writer?
It's uncommon. H-1B sponsorship requires an employer-employee relationship, which typically means a direct hire arrangement with a single employer who controls your work. Contract or freelance arrangements through staffing agencies can qualify if the agency holds the H-1B, but many agencies don't sponsor. Independent freelancing is generally not compatible with H-1B requirements. If contract work is your model, exploring the O-1 visa may be more practical depending on your credentials.
What is the prevailing wage requirement for sponsored Medical Writer 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.