Program Director Medical Writing and Quality
Program Director Medical Writing and Quality
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Job Description
University of Colorado Anschutz Medical Campus
Department: Gates Institute
Job Title: Program Director Medical Writing and Quality
Position #:Requisition #:36496
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 nonclinical clinical and programmatic topics.
This role will work crossfunctionally with scientists clinicians consultants statisticians and manufacturing experts to develop highquality scientific clinical and regulatory documents including clinical trial protocols Investigator Brochures Investigational New Drug (IND) modules and manuscripts. This position will require crossfunctional 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 highquality submissions.
Quality & Compliance:
- This role is responsible for strategically leading and set objectives for the Quality Management Program while supporting daytoday 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 from startup to closeout.
- 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 inperson meetings.
The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40000 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 haveAMAZINGbenefits and offerexceptional 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.
Equal Employment Opportunity Statement:
The University of Colorado (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 workplacewhere all individuals are treated with respect and dignity andwe encourage individuals from all backgrounds to apply.
Qualifications:
Minimum Qualifications:
- Bachelors degree in a Science field Behavioral Science Health Public Health Nursing or other related discipline at an accredited institution.
- 68 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 bachelors 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 healthrelated 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 nonclinical data as needed to prepare grants and manuscripts.
- Exceptional attention to detail.
- Effective collaboration and facilitation skills.
- Selfmotivated 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
Screening of Applications Begins:
Applications will be accepted until finalists are identified but preference will be given to complete applications received by April 4th 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 $80000 $135000.
The above salary range or hiring range represents the Universitys 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: 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 .
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 COVID19 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.
Required Experience:
Director
Employment Type
Full-Time
