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MDR - Medical Writer II
Ref No.: 17-06685
Location: Mansfield, Massachusetts
Start Date / End Date: 12/18/2017 to 01/11/2019
Spotlight call: Wednesday, November 8th at 10am Central time
Call in: 1-415-655-0003 US Toll
Access code: 921 720 122


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 Client Scientific Communications group.


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


Education & Experience:
• 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
• Clinical, scientific or research background

Preferred Skills/ Qualifications:
• 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