Medical Writer - I

Integrated Resources Inc.; Raynham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

A premier staffing firm seeks a Medical Writer Specialist to join their Client Strategic Medical Affairs Team. The role involves preparing essential regulatory documents and conducting literature reviews in the medical device industry. Candidates with a Ph.D. or relevant BS/MS degree and strong writing skills are encouraged to apply.

Qualifications

• Ph.D/Pharm D with 1-2 years of medical writing experience.
• BS/B.Pharm/BSN or MS/MPH with 4-5 years in medical device/drug industry.
• Experience writing Clinical Evaluation Reports (CERs) preferred.

Responsibilities

• Prepare and edit regulatory documents like Clinical Evaluation Reports.
• Conduct routine literature reviews for specific medical device groups.
• Organize and incorporate data and references into documents.

Skills

Excellent English language skills

Clinical background

Scientific writing

Statistical understanding

Project management

Interpersonal relationships

Education

Ph.D/Pharm D

BS/B.Pharm/BSN or MS or MPH

Tools

Microsoft Office Suite

Bibliographic software

Job description

A Few Words About UsIntegrated 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.

This is Contract position with my direct client

Job Description

Overview:

The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences.

Key Job Activities:

• Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
  
• Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
• Performs scientific writing (e.g. abstracts, manuscripts, presentations).
• Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
• Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
• Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
• Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.
• Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.
• Communicates with various departments (e.g. Regulatory, Product Development, Clinical Research, Quality) to identify the necessary clinical and technical information.

Qualifications

Job Qualifications

Education

• Ph.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g. medical writing, regulatory affairs, clinical research, engineering)
• BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experience
  

Knowledge/Requirements

• Excellent English language skills, especially writing and proofreading.
• Clinical, scientific or research background, highly preferred.
• Experience writing CERs, highly preferred.
• Knowledge in narrative or systematic literature reviews (e.g. PRISMA, Cochrane), highly preferred.
• Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.
• Expert understanding of scientific or clinical research and methods.
• Understanding of statistical data and good data management practices.
• Strong oral communication, presentation, project management and prioritization skills.
• Excellent interpersonal relationships.
• Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).