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.
See All Medical Writing Manager JobsOverview
Showing 5 of 64+ Medical Writing Manager jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 64+ Medical Writing Manager jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Medical Writing Manager roles.
Get Access To All JobsWho We Are
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science.
For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (in collaboration with AbbVie)
About The Role
Prepares and reviews clinical/regulatory documents that are high quality, concise, and comply with internal and external standards in support of all phases of drug development. Participates as subject matter expert for Medical Writing on product teams, leads the authoring process, works with contractors, and participates in timeline development for documents and New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs). This role is located at our beautiful campus in San Diego CA, we offer relocation support for those not local.
Your Contributions (include, But Are Not Limited To)
- Leads the authoring process for a variety of clinical/regulatory documents (eg, clinical study protocols; clinical study reports; investigator brochures; briefing documents; M2 Clinical Summary Documents for INDs, NDAs, and MAAs, PIPs, PSPs; response to regulatory questions; and other regulatory documents as appropriate
- Ability to independently interpret and communicate scientific data
- Represents Medical Writing on project teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Nonclinical, and Regulatory) from a writing and scientific perspective
- Interprets scientific data and interacts with functional leads in data interpretation and positioning in documents
- Leads comment resolution meetings
- Ensures documents are clear, concise, strategic, and well positioned for public disclosure
- Researches, recommends, and participates as a key contributor for implementing best authoring best practices and provides continuous training to teams
- May train / lead lower level staff
- Assist other writers on NDAs and MAAs
- Other duties as assigned
Requirements
- BS/BA degree in life sciences or related field AND 6+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred.
OR - Master’s degree in life sciences or related field AND 4+ years of similar experience noted above
OR -
PhD in life sciences or related field AND 2+ years of similar experience noted above
-
Ability to independently (with minimal supervision) understand, interpret, and communicate scientific data
- Understands the drug development process
- Exhibits leadership through supporting and leading writing best practices with cross-functional teams
- Strong understanding of the medical writing process, procedures, regulatory requirements, and systems (eg., DMS)
- Ability to meet multiple deadlines across a variety of projects, with a high degree of accuracy and efficiency
- Excellent communications, problem-solving, analytical thinking skills
- Ability to be a supportive, effective, and valued team member
- Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses
- Ability to communicate data in a manner that is accurate and provides the appropriate understanding of the benefit/risk of a product
- Proven ability to lead teams through the authoring process
- Ability to provide constructive feedback as it relates to communicating and positioning nonclinical and clinical data
- Excellent understanding of the writing and regulatory process that enables streamlining of content and processes
- Experience working with and leading contract medical writers
- Experience with NDA/MAAs or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.) is preferred
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
Compensation
- The annual base salary we reasonably expect to pay is $132,700.00-$182,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
- In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program.
Benefits
Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
Who We Are
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
What We Do
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science.
For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (in collaboration with AbbVie)
About The Role
Prepares and reviews clinical/regulatory documents that are high quality, concise, and comply with internal and external standards in support of all phases of drug development. Participates as subject matter expert for Medical Writing on product teams, leads the authoring process, works with contractors, and participates in timeline development for documents and New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs). This role is located at our beautiful campus in San Diego CA, we offer relocation support for those not local.
Your Contributions (include, But Are Not Limited To)
- Leads the authoring process for a variety of clinical/regulatory documents (eg, clinical study protocols; clinical study reports; investigator brochures; briefing documents; M2 Clinical Summary Documents for INDs, NDAs, and MAAs, PIPs, PSPs; response to regulatory questions; and other regulatory documents as appropriate
- Ability to independently interpret and communicate scientific data
- Represents Medical Writing on project teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Nonclinical, and Regulatory) from a writing and scientific perspective
- Interprets scientific data and interacts with functional leads in data interpretation and positioning in documents
- Leads comment resolution meetings
- Ensures documents are clear, concise, strategic, and well positioned for public disclosure
- Researches, recommends, and participates as a key contributor for implementing best authoring best practices and provides continuous training to teams
- May train / lead lower level staff
- Assist other writers on NDAs and MAAs
- Other duties as assigned
Requirements
- BS/BA degree in life sciences or related field AND 6+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred.
OR - Master’s degree in life sciences or related field AND 4+ years of similar experience noted above
OR -
PhD in life sciences or related field AND 2+ years of similar experience noted above
-
Ability to independently (with minimal supervision) understand, interpret, and communicate scientific data
- Understands the drug development process
- Exhibits leadership through supporting and leading writing best practices with cross-functional teams
- Strong understanding of the medical writing process, procedures, regulatory requirements, and systems (eg., DMS)
- Ability to meet multiple deadlines across a variety of projects, with a high degree of accuracy and efficiency
- Excellent communications, problem-solving, analytical thinking skills
- Ability to be a supportive, effective, and valued team member
- Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses
- Ability to communicate data in a manner that is accurate and provides the appropriate understanding of the benefit/risk of a product
- Proven ability to lead teams through the authoring process
- Ability to provide constructive feedback as it relates to communicating and positioning nonclinical and clinical data
- Excellent understanding of the writing and regulatory process that enables streamlining of content and processes
- Experience working with and leading contract medical writers
- Experience with NDA/MAAs or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.) is preferred
Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
Compensation
- The annual base salary we reasonably expect to pay is $132,700.00-$182,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
- In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program.
Benefits
Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
How to Get 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.
Medical Writing Manager jobs are hiring across the US. Find yours.
Find Medical Writing Manager JobsSee all 64+ Medical Writing Manager jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Medical Writing Manager roles.
Get Access To All JobsFrequently 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 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, which has no lottery and is available year-round. Canadians and Mexicans may qualify for TN 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.
See which Medical Writing Manager employers are hiring and sponsoring visas right now.
Search Medical Writing Manager Jobs