Associate Director, Medical Writing

Location
Bridgewater, NJ
Posted
Sep 23, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

Company Description

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. 

Overview

The Associate Director, Medical Writing 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.

This position will be based in our Corporate Headquarters in Bridgewater, NJ. Remote work arrangements can be accommodated, with travel to Bridgewater as needed.

Responsibilities

  • Critically review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency;
  • Act as liaison between internal and external reviewers and the external writer;
  • Organize and lead cross-functional meetings;
  • Understand clinical data and use text, tables, and figures as appropriate to accurately and effectively convey key messages;
  • Participate in appropriate development teams and internal strategy and operations meetings.
  • Oversight/management of permanent and contract staff and / or CROs

Qualifications

  • Master’s (Scientific), PhD, or PharmD
  • Minimum of 8 years of medical writing/editing, scientific publication management in the biotechnology or pharmaceutical industry, preferably with experience in Infectious Diseases or Pulmonary Disorders, or related areas
  • 7 – 10 years of experience in medical and regulatory writing and in managing CROs/consultants (contractors)
  • 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
  • Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems
  • Must demonstrate a high-quality writing style in the English language and can independently analyze and synthesize data from a broad range of disciplines
  • Progressive experience in medical writing
  • Oversight/management of permanent and contract staff or CROs
  • Must have excellent communication skills (verbal and written)
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Demonstrated collaborative and cross-functional approach to delivering functional results
  • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies. 
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Information

Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.