Scientific Medical Writer Senior Atrium Health - REMOTE

Department:

80096 Carolinas Medical Center - LC: Clinical Trials: Morehead

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Varies

Able to hire candidates from these states: AL, CO, FL, GA, ID, KS, KY, ME, MI, NC, SC, VA, VT, WA

Pay Range

$37.50 - $56.25

Job Profile SummaryServes as a subject matters expert in the development, maintenance and revision of technical documents including grants, manuscripts, protocols, and standard operating procedures (SOPs). Performs management level work directed toward the planning, development and evaluation of assigned projects. Represents the Department as a subject matter expert and liaison between technical, scientific, and quality control staff. Under limited supervision, writes, edits, and proofreads clinical trial protocols for a large group of investigators, assists with writing and editing grant applications, and edits scientific manuscripts for submission to peer-reviewed journals. Work with identified groups to maintain documents and supporting systems. Solves complex technical writing, editing and document administration issues following applicable regulations and standards.

EDUCATION/EXPERIENCE: PhD and five years of scientific writing experience in a clinical, scientific or publishing environment; or an equivalent combination of education and experience.

LICENSURE, CERTIFICATION, and/or REGISTRATION: N/A

ESSENTIAL FUNCTIONS:

1. Leads scientific writing, research and department projects.

2. Under limited supervision, performs the functions of medical writing, editing and strategic thinking for the development of clinical trial protocols for a wide range of complex and highly-specialized research in clinical, basic, and population sciences. Writes and/or edits grant applications, manuscripts, abstracts, and posters. Creates and edits controlled documents, such as SOPs, at all levels of complexity consistent with current formats and department style guides.

3. During the protocol development process, works with principal and co-investigators to establish study objectives, outcome measures, and pertinent data collection elements. Interacts with biostatisticians to ensure that analytic plans are complete and accurate to meet study objectives.

4. Coordinates with other departments, committees, staff, and other individuals within the unit and the institution (e.g. the Institutional Review Board) to identify operational, analytical, or other issues in protocol design. Attends meetings to provide guidance on protocol development. Attends meetings to monitor trial progress and the need for protocol changes to rectify operational issues.

5. Tracks and communicates ideas, project goals, results, and status of document changes.

6. For clinical trials that plan to utilize an Investigational New Drug (IND), assists principal investigators with the completion of all required documentation, including pre-IND consultations, IND applications, annual progress reports, and other documentation required by the U.S. Food and Drug Administration (FDA).

7. Create and/or change protocol templates as appropriate based on review of operational and analytical issues.

8. Develops and updates specifications for protocol design, particularly to be used as a tool for new clinical investigators.

9. Writes, edits and assists with large, detailed and vital federal grants, as well as assist in the creation of other grants.

10. Writes, prepares, edits and assists Principle Investigator for grant applications for various agencies, including federal, foundation and institutional. Must be able to assist investigators in the interpretation of the funding agency's or industry partner's requirements.

11. Facilitates the acquisition of extramural funding by identifying potential funding sources and providing guidance to investigators in leveraging the identified grant opportunities.

12. Provides updates to administration regarding progress of protocol and grant projects.

13. Prepares federally-required reports regarding research activities and funding.

14. Performs other related duties as assigned.

SKILLS/QUALIFICATIONS:

Expert level scientific/medical writing background and knowledge with history of successful research publication

Grant writing experience

Must demonstrate a clear, high quality, scientific writing sty