Sr. Medical Writer

Sr. Medical Writer

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. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

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 (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

Qualifications

Special Notes:

• 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 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