Protocol/ Scientific Writer - Massey Cancer Center
Virginia Commonwealth University
Richmond, VA
Full-time
Writing / Editing
Posted on May 28, 2023
Massey Cancer Center
“To improve the lives of all Virginians by delivering cutting-edge cancer care through patient-centered prevention and treatment; high-impact, innovative research; community input and engagement; and education and training of the next generation of researchers and healthcare professionals.”
Virginia Commonwealth University (VCU) Massey Cancer Center is a nationally ranked cancer center located in the heart of Downtown Richmond. All full-time staff are eligible for our generous benefits package that includes choices for health, vision, and dental coverage, life-insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity and cash match programs, flexible spending accounts, tuition benefits, significant paid-time off,12 paid holidays, and more. Explore our benefits further here: https://hr.vcu.edu/current-employees/benefits/
Position Primary Purpose and General Responsibilities
The purpose of this position is to provide scientific writing and editing support to Massey Cancer Center Investigators who are developing:
- Clinical research documents including but not limited to clinical protocols, informed consent form(s), FDA Investigational New Drug applications, Investigational Device Exemption applications
- Applications for funding opportunities including but not limited to non-profit foundation requests for proposals, VCU/MCC, and where appropriate NIH grants specific to support of clinical research activities
- Study reports including but not limited to scientific manuscript, meeting abstracts, final study summaries, posters, slide sets
- Massey Cancer Center supports a diverse faculty, staff, and student environment. The candidate will demonstrate experience that shows their commitment to fostering such an environment.
- Bachelor's degree in a science or health profession
- At least five years of experience with technical, scientific, or medical writing in an academic medical environment, a pharmaceutical environment, a biotechnology company environment, or the equivalent (no more than two years of this requirement may be satisfied by experience in a relevant advanced degree program or post-doctoral position)
- At least five years of experience in analyzing data, interpreting information, and providing logical conclusions
- Demonstrated ability to write, edit, and proofread medical and scientific documents
- Extensive knowledge, understanding, and writing and editing experience in at least one of the following areas: (a) clinical trial protocol development; (b) investigational new drug applications including the general investigational plan, investigator's brochure, CMC information, and pharmacology and toxicology information sections; and (c) manuscript preparation for biomedical research journals
- Knows and understands the applicability of the Code of Federal Regulations and guidance documents from the FDA, OHRP, and ICH on research with human subjects
- High level of proficiency with Microsoft Word; proficient with Microsoft Excel and Power Point and with Adobe Acrobat
- Advanced degree preferred
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external customers.
- Ability to identify issues and generate solutions or request appropriate intervention by management.
- Excellent organizational, communication, and interpersonal skills, both oral and written.
- Advanced understanding of medical and scientific terminology, especially as it relates to oncology and biomedical basic and clinical research.
- Proven ability to work in a fast paced, demanding environment and adapt to changing priorities without supervision
Position Details:
Department: Massey Cancer Center
Employment Type: UF - University Employee FT
Restricted Status: No
FTE: 100
Exemption Status: Exempt
University Title: Sr Scientific Writer RS 1 (34224)
Contact Information:
Contact Name: Massey Human Resources
Contact Email: MasseyHR@vcu.edu
Contact Phone: