Sr. Medical Writer

• 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

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

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

• Gold Seal JCAHO Certified ™ for Health Care Staffing
• “INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)