PROTOCOL WRITER I

Posted 17 Days Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
32K-49K Hourly
Junior
Healthtech • Biotech
The Role
Writes, edits, and completes clinical trial protocols and related regulatory documents for investigator-initiated and early-phase studies. Collaborates with principal investigators, the Clinical Trials Office, external sponsors, and grant administrators to prepare submissions, ensure regulatory compliance, and support clinical research proposals. Manages multiple concurrent projects and deadlines while providing scientific editing support.
Summary Generated by Built In
Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer.As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times’ Top Workplaces.

Summary

With an emphasis on investigator-initiated, early phase clinical trials, the clinical research Protocol Writer works with clinical investigators to write, edit and complete clinical trial protocols and related documents necessary to accurately and timely submit clinical trial projects to the Scientific Review Committee (SRC). Works under the direction of the Principal Investigator (PI) to edit, write, and gather technical and scientific documentation required to conceptualize, prepare, and deliver complete clinical protocol proposals to the SRC.

Protocol Writer I

With an emphasis on investigator-initiated, early phase clinical trials, the clinical research Protocol Writer works with clinical investigators to write, edit and complete clinical trial protocols and related documents necessary to accurately and timely submit clinical trial projects to the Scientific Review Committee (SRC).

Works under the direction of the Principal Investigator (PI) to edit, write, and gather technical and scientific documentation required to conceptualize, prepare, and deliver complete clinical protocol proposals to the SRC.

Responsibilities also include working with the Clinical Trials Office to ensure adherence to Moffitt's standards and regulatory requirements and with the PI, working with external sponsors on study design.

Secondary responsibilities include supporting clinical science editing activities. For select grants that include clinical trials, the position will work with Grant Administrators on the clinical research portion of the proposal, including developing the protocol and related documents outlined in the PHS Human Subjects and Clinical Trials Information Form as required for NIH defined clinical trials.
Position requires deadline-driven approach and ability to handle multiple concurrent projects, each with varying deadlines for execution.

Minimum Requirements:

Bachelor's Degree

Strong scientific/medical/health-related background with clinical research experience preferred.

Experience must include at least 2 years of relevant medical writing industry experience and a proven track record in writing high-quality regulatory documents.

Preferred Qualifications:
MA, MS, MD, PharmD, or PhD with 1 year of scientific experience and/or clinical research experience.


Salary Range

$31.99 - $48.80

Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions.


We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.


Moffitt Career Site

 

 

If you have the vision, passion, and dedication to contribute to our mission,then we have a place for you!

1. Equal Employment Opportunity

Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.

2. Reasonable Accommodation

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Moffitt endeavors to make moffitt.org/careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact one of the Human Resources receptionists by phone at 813-745-7899 or by email at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Read more information about your EEO rights under the law

Transparency in Coverage Rule

Skills Required

  • Bachelor's degree
  • Strong scientific, medical, or health-related background
  • At least 2 years of relevant medical writing industry experience
  • Proven track record writing high-quality regulatory documents
  • Clinical research experience
  • MA, MS, MD, PharmD, or PhD
  • 1 year of scientific experience and/or clinical research experience
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
11,000 Employees
Year Founded: 1986

What We Do

Moffitt Cancer Center is a Florida-based, NCI-designated comprehensive cancer center focused exclusively on cancer treatment, prevention, research, education and innovation. Its multidisciplinary clinicians and scientists work together to improve diagnosis, develop revolutionary breakthroughs, deliver individualized care and save more lives. Moffitt operates dedicated cancer hospitals and outpatient centers and serves patients while advancing oncology science through integrated clinical care and translational research.

Similar Jobs

Wipfli Logo Wipfli

Senior Accountant

Cloud • Fintech • Software • Business Intelligence • Consulting • Financial Services
Remote or Hybrid
Minneapolis, MN, USA
2900 Employees
74K-100K Annually

Wipfli Logo Wipfli

Senior Accountant

Cloud • Fintech • Software • Business Intelligence • Consulting • Financial Services
Remote or Hybrid
Chicago, IL, USA
2900 Employees
77K-104K Annually

Wipfli Logo Wipfli

Senior Accountant

Cloud • Fintech • Software • Business Intelligence • Consulting • Financial Services
Remote or Hybrid
Billings, MT, USA
2900 Employees
71K-95K Annually

Wipfli Logo Wipfli

Senior Accountant

Cloud • Fintech • Software • Business Intelligence • Consulting • Financial Services
Remote or Hybrid
Milwaukee, WI, USA
2900 Employees
74K-100K Annually

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account