Medical Writer jobs in Cary, NC

Institute for Medical Research at the Durham VA Health Care System

Scientific Writer

PI: Dr. Stephen Freedland

The Institute for Medical Research (IMR), an affiliate of the Durham VA Health Care System (DVAHCS), is looking for a full-time Scientific Writer to assist with pre- and post-award scientific writing in support of clinical research studies conducted by the Principal Investigator, Dr. Stephen Freedland, and his associates in his urology and oncology research lab.

Location: This position is remote with occasional in-person, team-wide meetings approximately 4 times annually. IMR employees must reside in the state of North Carolina.

Duties and Responsibilities:

Critical Element 1 – Pre-Award Research Planning, Writing, and Mentorship:

• Support proposal development for a wide range of awards, including investigator-initiated studies, collaborative studies, and industry-sponsored studies
• Facilitate communication with study sponsors, contractors, PIs, and research team members to develop actionable proposal materials
• Prepare proposal submissions by providing intellectual and scientific input, budget preparation, SOW development and writing, and contracting support
• Develop study design(s) appropriate for achieving study objectives
• Perform literature reviews in support of grant and proposal development
• Incorporate feedback from PI, Director, and other study team members into revisions of research writing
• Coordinate with research operations staff to obtain feedback on proposed study budgets and timelines
• Assess projects for potential scientific, feasibility, financial, and contractual risks
• Provide guidance and support to proposal and grant writers and assist with training, as needed

Critical Element 2 – Work with IMR Administration to facilitate contracts for clinical research performed by the Principal Investigator(s) at the DVAHCS

• Facilitate with the IMR administrative office to develop and execute research agreements including: Scope of Work, Non-Disclosure Agreement, Budget, Data Use Agreement, CRADA, Material Transfer Agreement, and Personnel Service Agreement, and Sub-awards
• Ensure CRADA and statement of work language is consistent with other contractual and regulatory documents including data use agreements, consents, and protocols
• Ensure conflict of interest statements have been completed and acquired for all relevant parties
• Coordinate contract development and execution for independent contractors with IMR administrative office staff

Critical Element 3 – Maintain electronic and paper documentation of contracts, grants, and budgets:

• Maintain electronic documentation for contracts, grants, and budgets
• Maintain an organized versioning system of all documents
• Perform literature reviews in support of research writing
• Use citation management software to organize references and format citations within writing products
• Communicate contractual and budget updates to research operations staff; provide education and training as needed
• Participate in finance meetings, including agenda development, status reports, and recording and distribution of meeting minutes
• Create and submit study account extensions and/or closures as needed

Critical Element 4 – Assist with grant writing and submission:

• Assist with preparation of grant documents
• Identify appropriate grant mechanisms, if needed
• Facilitate preparation of grant budget and budget justification
• Facilitate preparation of related supporting documents for grant submission
• Complete submission materials in a timely manner to meet institutional and grant deadlines
• Provide technical writing support as needed, inclusive of document workflow management
• Incorporate feedback from PI, Director, and other study team members into revisions of grant documents

Critical Element 5 – Research Writing and Mentorship:

• Assist in preparation of research and scientific products initiated by the laboratory, including study reports, abstracts, manuscripts, and posters
• Provide technical writing support and supervision of junior staff, as needed
• Stay informed of medical and scientific developments in the healthcare space by continuously reviewing literature in the field
• Incorporate feedback from PI, Director, and other study team members into revisions of research writing

Non-critical elements:

• Work effectively as part of a team
• Adhere to safety and compliance regulations
• Assist other research personnel

Qualifications:

• Requires a PhD, MD, or PharmD and a minimum of 2-3 years of relevant experience, strong writing skills, strong basic math skills, and budget development experience.
• Please be prepared to provide writing samples.

Additional Requirements:

• Candidates must be able to work diplomatically and professionally with administration, faculty, study team leads, and clinical personnel.
• In addition, must possess the following skills: strong speaking and writing ability, proofreading, telephone etiquette, professional initiative, and a high level of proficiency with Microsoft Windows, Word, and Excel.
• Knowledge in endnote or citation management software, technical writing, urology, and oncology is a plus.
• Prior experience with clinical research, FDA regulations, grant writing and HIPAA considerations is preferred.
• Applicants must possess knowledge of research study design principals, clinical trial study operations, statistical considerations (power, matching, etc.), and data/specimen collection methodologies.

Physical Requirements: The physical requirements and activities that are required to perform the essential functions of the position include, but may not be limited to, as follows: Must be able to occasionally lift, pull and push a minimum of 20 pounds, stand for extended periods of time, sit for extended periods of time, squat, kneel, and stoop, regularly use fingers, hands for computer work.

Supervisory Controls: The position of Scientific Writer is under the direct supervisor of the Proposal and Grants Team Lead.

The prior statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Salary Range: $60,000 - $100,000 per year

Status: Exempt

Start Date: Expected start date will be 4- 6 weeks after the offer but is somewhat flexible and contingent upon completion and approval of VA paperwork.

Employee Benefits: IMR offers a competitive benefits package which includes health, dental, vision, short and long term disability insurance. IMR offers a matching 403b retirement savings plan, and paid holiday, vacation, and sick leave. Please visit https://imr.org/benefits/ for information about employee benefits.

All IMR employees are required to obtain a Workers Without Compensation (WOC) appointment at the Durham VA Health Care System (DVAHCS). As a result, the successful candidate must undergo a federal background check and may be subject to a physical and drug test. Participation in the vaccination programs may be required for all Department of Veterans Affairs Health Care Workers Without Compensation (WOC) appointments. We will not sponsor applicants for work visas.

Equal Opportunity Employer, including disabled persons and Veterans.

Click here to apply to this position and others directly on the Institute for Medical Research Careers Page!