Title: Sr. Medical Writer
Duration: 2 years
Location: Mansfield, MA 02048(100% possibility of relocation)
Summary of position:
The Medical Writer is responsible for the preparation of documents that support the presentation, publication needs of assigned therapeutic areas and/or products in the Covidien Scientific Communications group.
Remote candidates are an option. Local candidate to Mansfield, MA preferred.
Essential functions:
- This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries) documents and responses to Notified Bodies.
- Post Market Surveillance activities (monthly literature review of our product)
- Scientific Writing e.g. abstracts, manuscripts, presentations
- Requires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical data
- Independently, critically writes and edits scientifically complex documents for substantial intellectual content
- Reviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goals
- Expert knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices
- Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences
Non-essential functions:
1. Other duties as assigned with or without accommodation.
Minimum requirements:
- Clinical, scientific or research background
- Ph.D./Pharm.D plus 1 to 2 years of related pharmaceutical/medical device industry experience
- (e.g., medical writing, clinical research)
- BS, B. Pharm, MS, plus 4 to 6 years of relevant pharmaceutical/medical device industry experience
- Experience in Medical Writing
- Communication/Presentation Skills
- Excellent Interpersonal Relationships
- Expert understanding of scientific or clinical research and the scientific method
- Demonstrated scientific writing ability
- Must be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint); skill in Microsoft Excel, Photoshop, Illustrator, EndNote Reference Software, and other scientific graphics software would be helpful
- Good understanding of statistical methods
Other Skills:
Organizational relationships/scope:
The Medical Writer will report to the Sr. Director of Scientific Communications. This position will meet and communicate regularly with Clinical Affairs, PACE, R&D, marketing, Sales, KOL’s and others as necessary to build and collaborate