Integrated Resources Inc.
Integrated Resources Inc. is hiring: Sr. Medical Writer in Mansfield
Integrated Resources Inc., Mansfield, MA, US, 02048
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time.
Job Description 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 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 Other duties as assigned with or without accommodation.
Requirements Clinical, scientific or research background
Ph.D./Pharm.D plus 1 to 2 years of related pharmaceutical/medical device industry experience
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
Organizational Relationships 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
Qualifications 100% remote work is possible, on site is preferred
PHD with 5+ years of experience or Nurses with 10+ years of experience is required
The Medical Writer has to review the post market surveillance data, has to create a demonstration of safety reports
Extensive experience with Clinical Evaluation Report is required, person has to be able to analyze complex scientific information
Post Marker Surveillance experience is required
Good understanding of risk management and hands on experience with risk management documentation is required
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