Bristol-Myers Squibb Company

Scientific Writer

Location
Princeton, NJ, US
Posted
Aug 07, 2018
Ref
R1508750
Required Education
Doctorate/PHD/MD
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.

Major Responsibilities:
  • Integrates the key international markets (eg, China, Korea, Taiwan, Australia, Canada) regulatory, legal, scientific/medical and business perspectives in writing regulatory documentation to achieve company objectives.
  • Translates strategy for writing documentation into operational goals and objectives.
  • Understands and implements regulatory requirements for relevant documentation.
  • Leads the authoring of the regulatory documents with high quality and in line with regulatory requirements.
  • Integrates with the global medical writing group and uses standardized global writing processes and systems.
  • Establishes cooperative partnership with other functions.
  • Ensures the coordination and integration of the scientific, medical, and regulatory input from development team members into writing of regulatory documents.
  • Builds an efficient communication channel between international teams and global teams/functions to better understand country-specific requirements and their implementation into regulatory documents.


Requirements:
  • PharmD/PhD/MD in a relevant scientific discipline, or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent.
  • Strong scientific/medical background.
  • Good understanding of global pharmaceutical drug development and country-specific requirements for submission of regulatory dossiers to health authorities.
  • Understanding of country-specific regulatory principles and their impact on company's development and business.
  • Understanding of the complexities of cross functional management issues.
  • Understanding of legal and business aspects related to country-specific regulatory procedures and outcomes.
  • Demonstrated strong writing skills in English, preferably in authoring and leading the production of clinical/regulatory documents for submission.
  • Ability to analyze and interpret complex data from a broad range of scientific disciplines.
  • Significant experience in authoring clinical/regulatory documents.
  • 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.
  • Skills to read scientific documents in English and communicate with the global members.