Medical Writer III
KellyMitchell matches the best IT and business talent with premier organizations nationwide. Our clients, ranging from Fortune 500 corporations to rapidly growing high-tech companies, are exceptionally served by our 1500+ IT and business consultants. Our industry is growing rapidly, and now is a great time to launch your career with the KellyMitchell team.
Job Summary: Medical Writer III
- Medical writing activities for a program (eg, a compound with one indication or single indication within a compound or several compounds if scope is small).
- With some oversight, provides strategic direction to cross-functional project team to ensure that clinical documents (eg, investigatorsbrochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements.
- Lead development of quality deliverables (development, review, approval) that are scientifically rigorous, logically organized, and accurate data presentation and interpretation.
- Activities (performed with some oversight) include, but are not limited to, writing, development of timelines, project management of the MW deliverables, participation on project team.
- May mentor less experienced writers.
- Generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration.
- Leading activities for assigned project(s) including writing key deliverables.
- Leading or participating on non-project related initiatives
Desired Skills/ Experience:
- Ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
- Ability, with some oversight, to lead the development, review, and approval of all clinical document types (ie, those typically developed by MW)
- Basic project management skills including understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups
- Ability to manage work timelines within assigned program(s).
- Strong written presentation skills and ability to present information to others Effective oral presentation skills (ie, ability to effectively lead a meeting and present issues)
- Ability to interact effectively with team members/leaders
- Ability to assess issues and develop potential solutions
- Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP)
- Working knowledge of the regulatory guidance regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs).
- Strong knowledge of MS Word (required), Excel (preferred), Project (preferred), Powerpoint (preferred), and Outlook.
- Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types.
- Education: Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelors degree required.
- 5-7 years experience in clinical/pharmaceutical development with directly related medical writing experience.
- Global regulatory submission experience preferred.