A leading Medical Device company has an opening for a Program Manager, Medical Writing Department.
The Program Manager, Medical Writing, will possess advanced project management, process development and refinement skills, along with an understanding of regulatory requirements for Post Market Clinical Follow Up (PMCF), Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) to support product registration efforts on the EU market.
The candidate will play a lead role in managing the medical writing department program by working closely with other departments and functional leaders to ensure the development of processes that will result in the creation high quality documents in alignment with project timelines and priorities. The Program manager will be responsible for leading efforts to refine medical writing processes with inputs and support from cross-functional core team members and the Lead Medical Writer. Additionally, this role will be responsible for the tracking and alignment of project milestones with Medical and Regulatory Affairs for all writing activities supporting European MDR and New Product Development across all product lines in the Business Unit.
The Program Manager will have had exposure to, and possess an in-depth understanding of regulatory documents including, but not limited to PMCF Plans/Reports, CEPs and CERs. Previous Regulatory or Clinical experience in writing is a plus. The candidate will provide day to day support to the medical writing team as the liasion between Medical Affairs and other core functions to ensure consistency in writing outputs, efficiencies, and milestone achievement. The Program Manager will be responsible for overseeing the program’s timeline, scope, resources, and reporting to Regulatory and Medical Affairs management.
- Project and program management experience.
- Must have excellent writing skills and the ability to communicate correctly and persuasively in English, and to use medical terminology accurately.
- Requires in depth working knowledge of Microsoft Office Products and ability to manage multiple projects, interact with multi-disciplinary teams, and work independently with minimal supervision.
- Ability to quickly acquire and apply understanding of therapeutic areas, medical device portfolios, business objectives, technical skills, clinical data/evidence.
- Ability to use judgment based upon standards and polices and meeting timelines.
- Good problem-solving and analytical skills. Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project.
- Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
- Experience writing CERs, highly preferred.
- Understanding of current regulatory and clinical requirements (e.g., European clinical requirements, including MEDDEV 2.7.1), highly preferred.
- Knowledge of narrative and systematic literature reviews required. Creativity with interpretation and presentation of data an asset.
- Excellent understanding of scientific or clinical research and methods required.
- Ability to establish rapport and collaborate with other (internal and external) team members.
Education & Experience:
- Bachelor’s degree (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing
- Minimum of 5 years of experience managing clinical programs and resources.
- Experience managing and developing people.
- In-depth understanding of PMCF, CER and CEP writing processes.
- Proficiency in MS Outlook, Word, Excel, and PowerPoint.