OPT Principal Medical Writer Jobs
Principal Medical Writer jobs are well-suited for OPT authorization, as the role consistently requires an advanced degree in a life sciences field, meeting the specialty occupation standard most employers use to evaluate F-1 candidates. STEM OPT extensions of up to 24 months are broadly available given the scientific nature of the work.
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Description University of Colorado Anschutz Medical Campus
Department: Orthopedics
Job Title: Clinical Research Services Principal Professional – Sports Medicine
Position #: 00796642
Requisition#: 39896
Job Summary:
This Clinical Research Services Principal Professional will serve as a lead Clinical Research Coordinator for the Sports Medicine division within the Department of Orthopedics at the University of Colorado. Jobs in this career family provide direct professional support of research activities directed by physicians. The specific focus of this position will be supporting the clinical trials efforts of the providers within this group. Primary research responsibilities for this position focus on sponsored and investigator-initiated studies of orthopedic interventions of the knee and shoulder that are conducted by several physicians. This position offers a unique opportunity to contribute to the work that is rapidly advancing and informing medical care for athletes at all levels.
Key Responsibilities:
- Functions include regulatory compliance, sponsor communication and post- and pre-award management, human subject compliance, research coordination and instruction, environmental health and safety, and shipping of biological materials.
- Principal professionals will also be expected to be able to perform all duties at the Senior Research Professional level including patient consenting, sponsor/monitor visit coordination, regulatory materials organization, and tracking of and accountability for deliverables.
Work Location:
Hybrid – this role is eligible for a hybrid schedule of # days per week on campus and as needed for in-person meetings.
Why Join Us:
The University of Colorado Department of Orthopedics Sports Medicine division is a dynamic and determined group in both clinical care and research. CU-Sports Med providers serve as the team physicians for the Denver Nuggets, Colorado Rockies, Colorado Avalanche, Colorado Mammoth, Colorado Rapids as well as the University of Colorado and multiple high schools throughout the front range of Colorado. Our research efforts include mainly the investigation of clinical outcomes on patients which range from the elite world class athlete to the recreational weekend warrior. Patient-facing interactions are wide and varied with unique athletes and patients from around the region. Research interaction is also varied with opportunities to collaborate with other sports medicine facilities and researchers across campus as well as across the country. CU-Sports Med collaborates on impactful multicenter research efforts nationally and internationally with research output presented around the world. This position offers a unique opportunity to contribute to the work that advances and informs medical care for athletes at all levels.
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
Qualifications
Minimum Qualifications:
- Bachelor’s degree in any field
- A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
- An advanced degree (Masters or PhD) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
- Three (3) years clinical research or related experience
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
- Bachelor’s degree in science or health related field
- Four (4) years of clinical research or related experience
- Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
Knowledge, Skills and Abilities:
- Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
- Outstanding customer service skills
- Knowledge of basic human anatomy, physiology medical terminology
- Ability to interpret and master complex research protocol information
- Expert level knowledge of regulatory processes related to Human Subjects Research
How to Apply:
For full consideration, please submit the following document(s):
- A letter of interest (PDF) describing relevant job experiences as they relate to listed job qualifications and interest in the position
- Curriculum vitae / Resume (PDF)
- Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address (PDF)
Questions should be directed to: Gregory Ottenberg, gregory.ottenberg@cuanschutz.edu
Screening of Applications Begins:
Screening begins on date of posting and continues until May 15, 2026.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as $67,511-$90,465.
The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator
Equal Employment Opportunity Statement:
CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Application Materials Required: Cover Letter, Resume/CV, List of References
Job Category: Research Services
Primary Location: Hybrid
Department: U0001 - Anschutz Med Campus or Denver - 20259 - SOM-ORTHO GENERAL OPERATIONS
Schedule: Full-time
Posting Date: May 8, 2026
Unposting Date: Ongoing
Posting Contact Name: Gregory Ottenberg
Posting Contact Email: gregory.ottenberg@cuanschutz.edu
Position Number: 00796642
University Staff
Description University of Colorado Anschutz Medical Campus
Department: Orthopedics
Job Title: Clinical Research Services Principal Professional – Sports Medicine
Position #: 00796642
Requisition#: 39896
Job Summary:
This Clinical Research Services Principal Professional will serve as a lead Clinical Research Coordinator for the Sports Medicine division within the Department of Orthopedics at the University of Colorado. Jobs in this career family provide direct professional support of research activities directed by physicians. The specific focus of this position will be supporting the clinical trials efforts of the providers within this group. Primary research responsibilities for this position focus on sponsored and investigator-initiated studies of orthopedic interventions of the knee and shoulder that are conducted by several physicians. This position offers a unique opportunity to contribute to the work that is rapidly advancing and informing medical care for athletes at all levels.
Key Responsibilities:
- Functions include regulatory compliance, sponsor communication and post- and pre-award management, human subject compliance, research coordination and instruction, environmental health and safety, and shipping of biological materials.
- Principal professionals will also be expected to be able to perform all duties at the Senior Research Professional level including patient consenting, sponsor/monitor visit coordination, regulatory materials organization, and tracking of and accountability for deliverables.
Work Location:
Hybrid – this role is eligible for a hybrid schedule of # days per week on campus and as needed for in-person meetings.
Why Join Us:
The University of Colorado Department of Orthopedics Sports Medicine division is a dynamic and determined group in both clinical care and research. CU-Sports Med providers serve as the team physicians for the Denver Nuggets, Colorado Rockies, Colorado Avalanche, Colorado Mammoth, Colorado Rapids as well as the University of Colorado and multiple high schools throughout the front range of Colorado. Our research efforts include mainly the investigation of clinical outcomes on patients which range from the elite world class athlete to the recreational weekend warrior. Patient-facing interactions are wide and varied with unique athletes and patients from around the region. Research interaction is also varied with opportunities to collaborate with other sports medicine facilities and researchers across campus as well as across the country. CU-Sports Med collaborates on impactful multicenter research efforts nationally and internationally with research output presented around the world. This position offers a unique opportunity to contribute to the work that advances and informs medical care for athletes at all levels.
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
Qualifications
Minimum Qualifications:
- Bachelor’s degree in any field
- A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
- An advanced degree (Masters or PhD) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
- Three (3) years clinical research or related experience
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
- Bachelor’s degree in science or health related field
- Four (4) years of clinical research or related experience
- Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
Knowledge, Skills and Abilities:
- Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
- Outstanding customer service skills
- Knowledge of basic human anatomy, physiology medical terminology
- Ability to interpret and master complex research protocol information
- Expert level knowledge of regulatory processes related to Human Subjects Research
How to Apply:
For full consideration, please submit the following document(s):
- A letter of interest (PDF) describing relevant job experiences as they relate to listed job qualifications and interest in the position
- Curriculum vitae / Resume (PDF)
- Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address (PDF)
Questions should be directed to: Gregory Ottenberg, gregory.ottenberg@cuanschutz.edu
Screening of Applications Begins:
Screening begins on date of posting and continues until May 15, 2026.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as $67,511-$90,465.
The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator
Equal Employment Opportunity Statement:
CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Application Materials Required: Cover Letter, Resume/CV, List of References
Job Category: Research Services
Primary Location: Hybrid
Department: U0001 - Anschutz Med Campus or Denver - 20259 - SOM-ORTHO GENERAL OPERATIONS
Schedule: Full-time
Posting Date: May 8, 2026
Unposting Date: Ongoing
Posting Contact Name: Gregory Ottenberg
Posting Contact Email: gregory.ottenberg@cuanschutz.edu
Position Number: 00796642
See all 36+ OPT Principal Medical Writer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Principal Medical Writer Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Principal Medical Writer
Lead with your regulatory writing experience
Principal-level roles require demonstrated ownership of clinical documents like CSRs, IBs, and NDA/BLA submissions. Quantify your output in your resume and cover letter. Employers sponsoring OPT want evidence you can operate independently from day one.
Target CROs and mid-size biopharma companies
Contract research organizations and growth-stage biopharma firms hire medical writers at volume and are more accustomed to OPT sponsorship than smaller startups. Their HR teams understand work authorization timelines and are better positioned to support your status.
Emphasize your therapeutic area depth
Generalist writers are easier to pass over. Employers prioritize candidates with deep experience in oncology, rare disease, or neurology. Positioning yourself within a specific therapeutic area signals you bring specialized value that justifies the sponsorship conversation.
Address your OPT timeline proactively
Don't wait for employers to raise the authorization question. Mention your OPT end date and STEM extension eligibility early in conversations. Clarity reduces hesitation and shows you understand the timeline, which builds employer confidence rather than concern.
Highlight your degree alignment clearly
Principal Medical Writer roles require a graduate degree in pharmacy, medicine, life sciences, or a closely related field. Make the connection between your degree and the role explicit in your application materials. Ambiguity about qualification creates unnecessary friction with hiring teams.
Build a portfolio of regulatory document samples
If permitted by prior employers, curate anonymized writing samples showing your range across document types. A portfolio demonstrating CSR structure, synopsis writing, or protocol drafting gives hiring teams concrete evidence of your capability at the principal level.
Principal Medical Writer OPT: Frequently Asked Questions
Can F-1 OPT students work as Principal Medical Writers?
Yes. Principal Medical Writer roles qualify under OPT because they consistently require an advanced degree in a life sciences or health-related field, meeting the specialty occupation standard. Most employers in pharma and CRO settings are familiar with OPT authorization. STEM OPT extensions typically apply given the scientific degree requirements involved.
Does a Principal Medical Writer role qualify for a STEM OPT extension?
In most cases, yes. The STEM OPT extension applies when your degree is on the USCIS STEM designated degree list and your employer is enrolled in E-Verify. Degrees in pharmaceutical sciences, biomedical sciences, chemistry, and biology commonly qualify. Confirm your specific degree is listed and that your employer meets the E-Verify requirement before applying for the extension.
How do I find Principal Medical Writer jobs open to OPT candidates?
Migrate Mate is the recommended platform for OPT students in this search. It filters for employers who sponsor work authorization, so you're not applying blindly to postings that will screen you out. Searching there saves significant time compared to filtering through general job boards where sponsorship openness is rarely disclosed upfront.
What degree do I need to qualify for Principal Medical Writer roles on OPT?
Most employers require a graduate degree, typically a master's or doctorate, in a field directly related to the work, such as pharmacology, biomedical sciences, medicine, pharmacy, or a clinical discipline. An undergraduate degree in a life sciences field may qualify for some postings, but principal-level roles almost universally expect advanced credentials to support both the job requirements and OPT eligibility.
How much OPT time should I have remaining when applying for Principal Medical Writer positions?
Aim to have at least six months of OPT remaining when you start applying. Principal-level hiring processes are thorough, often involving writing assessments and multiple interview rounds, which can take eight to twelve weeks. If you're STEM-eligible, your extension gives you additional runway, but starting the search early avoids unnecessary pressure on your authorization timeline.