Senior Medical Writer | BioNJ Talent Services

Senior Medical Writer

Contact Information
Contact Name: 
Insmed
Organization Name: 
Insmed
Position Location: 
Bridgewater
Company Profile: 

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

Job Description:

The successful candidate is responsible for the complete preparation, including but not limited to, the writing, reviewing and editing of protocols, Investigator Brochures (IBs), clinical study reports (CSRs), and Summary Modules for Regulatory Submissions. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems.

Responsibilities:
•Write high-quality first-draft content with minimal input from functional area experts
•Understands clinical data and uses text, tables, and figures as appropriate to accurately and effectively convey key messages.
•Coordinate the production of high quality clinical documentation (e.g. Clinical Study Reports and Summary Documents) for submission to regulatory authorities in support of NDAs and global marketing applications.
•Write/edit clinical study reports and summary documents for submissions.

Qualifications: 

•Minimum 5 years of experience with a Master’s of Science degree, PharmD, PhD or MD preferred; or Minimum 7 years of experience with a Bachelor's degree in Life Sciences or related field
•Regulatory medical writing experience highly preferred but not required
•Minimum of 5 years of medical writing/editing, publication management in the biotechnology or pharmaceutical industry, preferably with experience in Infectious Diseases or Pulmonary Disorders, or related areas
•Must demonstrate a high-quality writing style in the English language and have the ability to independently analyze and synthesize data from a broad range of disciplines
•Exceptional organizational and project planning skills
•Strong interpersonal skills and the ability to relate and work in a cross-functional environment with a wide range of people to achieve results
•Dynamic, self-starter with strong influential skills and adaptable to change
•Thorough knowledge of Good Publications Practices (GPP2) and Guidelines for Authorship of the International Congress of Medical Journal Editors (ICMJE 1997 Vancouver Criteria)
•Familiar with style rules from the American Association Manual of Style, 10th Edition and creation and use of consort diagrams
•Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other