Bristol-Myers Squibb Company

Medical Writer

Location
Hopewell, NJ, United States
Posted
Jun 22, 2019
Ref
R1513633
Required Education
Masters Degree/MBA
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Position Objective:
  • Coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
  • Participate in relevant document sub-team(s) and ensure effective planning and management of timelines for all components of assigned documents.
  • Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
  • Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
  • Review and edit documents as required.
  • Considerable experience in assignment on Cross Functional Teams would be an advantage.


Qualifications:
  • MS/BS with a minimum of 3 years (MS) to 5 years (BS) in the pharmaceutical industry, within pharmacovigilance or safety, with a good understanding of drug development, drug safety, and regulatory/safety document development.
  • Demonstrated strong writing skills in authoring and managing the production of scientific documents, specifically authoring PBRERs and DSURS.
  • Understanding of documentation requirements related to regulatory filings.
  • Basic understanding of global pharmaceutical drug development.
  • Ability to analyze and interpret complex data from a broad range of scientific disciplines.
  • Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
  • Working knowledge of a document management system.
  • Candidate should have the ability to speak English.