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Medical Writer

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that is generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

 

Job Description:

The Medical Writer will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs). This position will report to the Pharmacovigilance Manager. 

 

Essential Job Functions:

  • Produce high quality, consistent and on-time writing deliverables.
  • Editing and formatting to produce final version key documents, including clinical protocols, investigator brochures, clinical study reports, benefit/risk analyses, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.
  • Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
  • Collaborate effectively with Clinical Operations, Regulatory Affairs, Manufacturing, Research and Development, Product Development, Project/Program Management, Quality, and Device Manufacturing/Engineering, Corporate Communications, as well as with external stakeholders.
  • Contribute to the development of SOPs, Work Instructions, and templates to support preparation of high quality writing deliverables
  • Build processes to provide consistent information and messages across individual documents
  • Maintain and develop a standard writing style guide for key documents

Minimum Requirements:

Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
4+ years of experience as a medical/scientific writer in the sponsor or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus.
Knowledge and understanding of FDA and ICH regulations and guidelines
Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.

Essential Requirements:

Excellent oral and written communication, interpersonal and organizational skills, and impeccable attention to detail and ability to complete writing assignments in a timely manner with little to no oversight.
Familiarity with medical and scientific writing
Ability to communicate medical and scientific information in a clear and concise manner
Ability to consistently meet tight timelines and deadlines. Ability to interact effectively with management and prioritize multiple projects
Technical proficiency, effective problem solving and critical thinking skills
Ability to work in a team environment
Impeccable attention to detail and writing consistency
Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint. Experience with DocXtools or similar software tool is a plus

A current US work authorization is required.  

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.

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