Program Director, Medical Writing and Quality

Job Summary:

The Gates Institute at the University of Colorado Anschutz Medical Campus seeks a Program Director to strategically lead the clinical writing and clinical quality program, and oversee the development of clinical protocols, grants and manuscripts from early discovery through phase 1 clinical trials for all Gates Institute cell/gene therapies and regenerative medicine programs. This includes but is not limited to research, non-clinical, clinical, and programmatic topics.

This role will work cross-functionally with scientists, clinicians, consultants, statisticians, and manufacturing experts to develop high-quality scientific, clinical, and regulatory documents including clinical trial protocols, Investigator Brochures, Investigational New Drug (IND) modules, and manuscripts. This position will require cross-functional collaboration, excellent project management and writing skills, as well as a good understanding of the underlying science.

Key Responsibilities:

Protocol & Regulatory Document Management:

• Develop and maintain clinical study reports, protocols, amendments, informed consent forms, and site guidelines to ensure regulatory compliance and consistency.

Clinical Research Writing & Grant Development:

• Independently manage and contribute to the development of clinical protocols, manuscripts, grant proposals, and related scientific documents in collaboration with the GI teams, clinical teams, and other research collaborators.
• Serve as the Gates Institute (GI) as subject matter expert for collaborative grant application drafts, revisions, and finalization, ensuring high-quality submissions.

Quality & Compliance:

• This role is responsible for strategically leading and set objectives for the Quality Management Program while supporting day-to-day clinical operations. Key responsibilities include overseeing protocol management, documentation, and compliance for multiple highly complex Phase 1 clinical trials across internal and external teams, ensuring seamless execution from start-up to close-out.
• Implement and maintain quality control processes for all written deliverables, ensuring adherence to medical writing standards, journal requirements, and regulatory guidelines.
• Conduct thorough reviews, audits and quality checks to identify and correct inconsistencies, errors, and discrepancies in scientific content and formatting.

Training:

Develop Training programs and mentor junior research staff, providing guidance on best practices and quality assurance standards.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 2 days per week on campus and as needed for in-person meetings.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success!

In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.

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.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in a Science field, Behavioral Science, Health, Public Health, Nursing, or other related discipline at an accredited institution.
• 6-8 years of relevant clinical research experience in cell and gene therapy.

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Advanced degree, (MA, MS, PhD) preferably in life sciences or health-related field.
• 7 years of experience working in clinical research.
• One year of experience in clinical nursing or related field.
• Experience with synthesizing laboratory and animal research data into grants and publications.
• Experience with grant and manuscript development and submissions.
• Experience with developing and maintaining medical writing QC systems, Protocol management.

Competencies/Knowledge, Skills, and Abilities:

• An understanding of grant and manuscript development, drafting, formatting, and submitting.
• Able to adapt to ambiguous and/or changing situations and produce results.
• Ability to work on multiple projects and with multiple project teams at one time.
• Able to interpret clinical and non-clinical data as needed to prepare grants and manuscripts.
• Exceptional attention to detail.
• Effective collaboration and facilitation skills.
• Self-motivated, willing to take action with demonstrated ability to establish relationships
• Independent judgment, strong organization and communication skills, and a superior customer service focus
• Strong interpersonal skills (written and verbal) and high degree of professionalism
• Ability to prioritize and manage multiple projects and tasks
• Proficiency in Microsoft Suite

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Donna.3.Parker@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by April 4^th, 2025. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $80,000 - $135,000.

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: http://www.cu.edu/node/153125

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.