Technical Writer - Scientific - II

Integrated Resources Inc.; Raynham (MA); On-site; USD 70,000 - 120,000; Full time

Job summary

A leading staffing firm is seeking a Technical and Scientific Reviewer to provide insight and oversight on scientific content for regulatory documents. The ideal candidate will possess strong communication skills and a solid educational background, ideally a Ph.D. or relevant master's degree, and experience in medical writing or clinical research.

Qualifications

• Ph.D/Pharm D with 1-2 years of experience or BS/MS with 5-10 years.
• Background in clinical, scientific, or research preferred.
• Experience in medical writing or regulatory affairs preferred.

Responsibilities

• Provide leadership and strategic direction for regulatory documents.
• Review and develop scientific and medical content.
• Understand various assigned therapeutic areas.

Skills

Excellent English language skills

Strong oral communication

Project management

Interpersonal relationships

Education

Ph.D/Pharm D

BS/B.Pharm/BSN or MS or MPH

Tools

Microsoft Office Suite

Bibliographic software (Endnote, Reference Manager)

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.

Job Description

Technical and Scientific Reviewer

Summary:

The Technical and Scientific Reviewer provides leadership, motivation, and strategic direction for the scientific and technical content for prepared regulatory documents by the Medical Operations Team. The role is responsible for the review, development, and quality of scientific and medical content and demonstrates an understanding of all assigned therapeutic areas.

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).

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 5 to 10 years of relevant medical device industry experience