Medical Writing Manager Jobs in USA with Visa Sponsorship
Medical Writing Manager roles in the U.S. are regularly sponsored under the H-1B visa, which requires a bachelor's degree or higher in a relevant scientific or medical field. Most employers treat this as a specialty occupation with a clear degree requirement, making sponsorship straightforward for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsImagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
- As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT.
- Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports.
- Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables.
- Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge.
- Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders.
- Assist in the implementation of continuous process improvements as it relates to medical writing.
- Other incidental duties.
What you’ll need (required):
- Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science or equivalent work experience based on Edwards criteria Required.
What else we look for (preferred):
- Advanced degree (Master’s, PHD, Pharm D).
- Experienced with literature reviews and various publication databases including PubMed and Embase.
- Familiarity with the cardiovascular therapeutic area—including, but not limited to, structural heart interventions, coronary interventions, heart failure—and current treatment landscape; familiarity with clinical research and/or clinical trial experience.
- Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.
- Familiarity with FDA PMA applications.
- Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations.
- Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
Additional skills and general expectations:
- Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously.
- Excellent oral and written communication skills.
- Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
- Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat.
- Strong analytical, problem-solving, and scientific writing skills.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
- Ability to build productive internal/external working relationships.
- The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
LI-Remote
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
- As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT.
- Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports.
- Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables.
- Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge.
- Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders.
- Assist in the implementation of continuous process improvements as it relates to medical writing.
- Other incidental duties.
What you’ll need (required):
- Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science or equivalent work experience based on Edwards criteria Required.
What else we look for (preferred):
- Advanced degree (Master’s, PHD, Pharm D).
- Experienced with literature reviews and various publication databases including PubMed and Embase.
- Familiarity with the cardiovascular therapeutic area—including, but not limited to, structural heart interventions, coronary interventions, heart failure—and current treatment landscape; familiarity with clinical research and/or clinical trial experience.
- Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.
- Familiarity with FDA PMA applications.
- Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations.
- Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
Additional skills and general expectations:
- Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously.
- Excellent oral and written communication skills.
- Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
- Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat.
- Strong analytical, problem-solving, and scientific writing skills.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
- Ability to build productive internal/external working relationships.
- The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
LI-Remote
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Medical Writing Manager
Confirm your degree aligns with the role
Medical Writing Manager positions require a degree in life sciences, pharmacy, medicine, or a related field. A degree in an unrelated discipline, even with strong writing experience, can complicate specialty occupation approval. Employers will verify this alignment before filing.
Target employers with established H-1B track records
Pharmaceutical companies, CROs like ICON and Parexel, and large biotech firms file H-1B petitions regularly for medical writing roles. These employers have immigration counsel in place, which speeds up the sponsorship process significantly compared to first-time sponsors.
Understand the H-1B lottery timeline
H-1B registrations open in March each year for an October 1 start date. If you need sponsorship, begin conversations with employers well before March so your registration can be submitted without delay during the narrow window.
Ask about cap-exempt sponsorship if applicable
Hospitals, nonprofit research institutions, and university-affiliated medical centers are cap-exempt H-1B employers, meaning you can be sponsored year-round without entering the lottery. These are worth targeting if you cannot wait for the annual cap cycle.
Highlight regulatory writing experience in applications
Experience with FDA submissions, clinical study reports, or ICH guidelines signals specialized expertise that strengthens specialty occupation arguments. Employers and immigration attorneys use this experience to document why the role requires a specific degree field.
Clarify your OPT or grace period runway before applying
If you are on F-1 OPT, confirm your expiration date before accepting an offer. STEM OPT extension may apply if your degree qualifies. Employers need enough lead time to file your H-1B petition before your current work authorization lapses.
Frequently Asked Questions
Is Medical Writing Manager a visa-sponsorable role in the U.S.?
Yes. Medical Writing Manager is generally classified as a specialty occupation under the H-1B visa because the role requires a bachelor's degree or higher in a specific scientific field, typically life sciences, pharmacy, or medicine. Pharmaceutical companies, CROs, and biotech firms sponsor this role regularly. The specialty occupation argument is well-established, which makes USCIS approval more predictable than for generalist roles.
What visa types are available for Medical Writing Managers?
The H-1B is the most common visa for this role. Australians may also qualify for the E-3 visa, which has no lottery and is available year-round. Canadians and Mexicans may qualify for TN visa status under the USMCA, provided their degree is in a qualifying field. Candidates with extraordinary ability or peer-reviewed publications in medical writing may explore the O-1A, though it requires substantial documentation.
Do I need a specific degree to get sponsored as a Medical Writing Manager?
Your degree must be in a field directly related to the role, such as life sciences, pharmacy, nursing, medicine, biochemistry, or a closely related discipline. A general communications or English degree alone is unlikely to support the specialty occupation classification unless paired with substantial postgraduate scientific training. A degree in medical writing itself, offered by some institutions, also qualifies.
How competitive is H-1B sponsorship for this role, and what are my odds?
The H-1B lottery selects approximately 85,000 petitions from a pool that has ranged from 400,000 to 780,000 registrations in recent years, resulting in selection rates of roughly 14 to 25 percent depending on the year. However, cap-exempt employers, including nonprofit hospitals and university medical centers, can sponsor outside the lottery entirely. Exploring those employers through Migrate Mate can improve your odds of securing sponsorship without lottery dependency.
Can I switch employers while on an H-1B as a Medical Writing Manager?
Yes. H-1B portability allows you to start working for a new employer as soon as they file a new H-1B petition on your behalf, without waiting for approval, provided you have been maintaining valid H-1B status. The new employer must file before your current status expires. Your degree, role, and specialty occupation classification typically carry over without issue in medical writing, since the field-specific degree requirement is consistent across employers.
What is the prevailing wage requirement for sponsored Medical Writing Manager 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.