Regulatory And Communications Associate

Location : IC: NCATS Street: 9800 Medical Center DrBldg B Bldg: 9800B Room: 326 City: Rockville State & Zip: MD 20850

Weekly Hours FT: 3040 hours per week Total No. of Hours : 40

Overall Position Summary and Objectives

This position requires a PhD. The candidate will work independently and in teams to provide regulatory and communication support for the Therapeutic Development Branch focusing on gene therapy initiatives for dissemination and outreach efforts.

Min Education Masters

Resume Max Pages 3

ADDITIONAL QUALIFICATIONS

Certifications & Licenses

• PhD

Skills (Ranked By Priority)

1. Scientific writing and creation of materials to educate/inform on translational science projects
2. Ability to understand and analyze complex biomedical information and research programs and communicate this information clearly to a nonexpert/lay audience
3. Team work; exceptional interpersonal (oral and written) communication skills
4. Website content development
5. Regulatory support (document writing and reviewing)

1 2 3 4 5 represents priority rankings where 1 is highest priority and 5 is lowest priority of those ranked

Software

• Demonstrates expertise with Microsoft MS Office Suite (Word Excel etc.)
• Microsoft Teams Power BI Wordpress

Field of Study

• Biology

Statement of Work Details

Prepares scientific and technical materials for publication.

• Research write and edit in accordance with industry academic and publication standards book manuscripts and chapters peer reviewed journal articles conference and symposium proceedings and general print media articles. 1
• Coordinate with research and study teams and staff to develop outlines prospectus and abstracts of research and studies for submission to peerreviewed journals conferences and symposiums and book publishers in preparation for publication.
• Research write and edit scientific and technical information in a variety of formats including articles blog posts factsheets one pager brochures presentations and speeches workshop summaries reports briefing materials press releases content for digital media in online and print format. 2
• Research write and edit technical reports of original research specifications findings and conclusions for submission to administrative legislative and regulatory review.
• Assist in writing and reviewing regulatory documentation 3

Conducts advanced literature reviews and prepares reports summaries and presentations on findings.

• Perform literature reviews of scientific and technical literature to identify methodologies findings and conclusions of significance and prepare summaries and reports for distribution among research and medical staffs.
• Prepare summaries reports dashboards and presentations on results of literature reviews to researchers and staffs.

Creates and maintains databases of all research materials literature reviews and publications.

• Compile and organize primary research data from research conducted and develop tabular and graphical representations of the data.
• Attend and participate in multidisciplinary research team meetings and functions.

Develops and edits official program management reports official correspondence and audit reports.

• Assist program and project managers draft and edit scientific documentation related to research and operational projects.

Provide scientific and technical writing expertise to assist researchers and staff prepare documentation.

• Assist researchers develop scientific and technical documentation providing insights guidance and recommendations to improve products.
• Design and maintain templates and detailed usage instructions for preparing common documentation such as posters presentations reports proposals abstracts etc.

Finalizes documents and prepares materials for publication.

• Proofread all documents (drafts and final forms) for scientific and technical accuracy and completeness prior to submitting them for review and approval or acceptance.
• Complete and verify all necessary forms required for submission of manuscripts to scientific and peer reviewed journals.
• Critically review draft documents synthesize comments and incorporate appropriate comments from other reviewers into successive drafts to prepare final documents.

Provides expert guidance direction and support to executives in the development and distribution of scientific and technical written materials.

• Meet with staff on a regular basis to provide oral reports on the status of ongoing projects and to receive new assignments. Continually organize and track progress and documentation
• Generate content and implement dissemination of content on a public facing website working with the program team and following guidelines 5

Mentors coaches and trains writers editors and staff on scientific and technical writing and editing practices and procedures.

• Researchers repackages and shares among research and operational staff best practices tips and practices for improving the quality and consistency of scientific and technical writing.
• Develop templates and SOPs for regulatory meetings and milestones 4