Bristol Myers Squibb Company

Senior Scientific Writer

Location
Celgene, NJ, United States
Posted
Sep 05, 2020
Ref
R1527434
Required Education
Doctorate/PHD/MD
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary / Objective
  • To author complex regulatory documents ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.
  • Coordinate and author study protocols ensuring high quality documents that are compliant with established regulatory processes
  • To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by the Development Teams


Position Responsibilities
  • Ensures that all assigned documents support the full development strategy to achieve target labeling objectives and timely approvals in key markets.
  • Participates in relevant subteam(s) of the EDT, FDT or LCM team and ensures effective planning and management of timelines for all components of assigned documents.
  • Participates and/or leads document prototyping sessions including the design of data displays, document flow, logic and consistency for assigned project prototypes; critically reviews project specific model documents, maintains document prototypes/shell reports.
  • Documents and implements consensus at meetings to determine data interpretation and key findings/messages.
  • Authors complex clinical documents (e.g. protocols, phase II/III clinical study reports, high level summary documents), and certain non-clinical documents (eg, initial Investigator's Brochure) for timely submission to health authorities worldwide according to:
  • good documentation principles (organization, clarity, scientific standards)
  • consistency between text and tabular presentations or graphical displays
  • in compliance with BMS documentation standards and worldwide regulatory requirements
  • Manages the review process and, on an ongoing basis, resolves issues, errors, or inconsistencies with pertinent team members to ensure:
  • optimal communication between authoring team and development team members
  • coordination and efficient use of messages between internal development plans, IND and NDA documentation
  • timely completion and high quality of assigned documents
  • Reviews and edits documents as required.
  • Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
  • As required, coordinates writing of responses to health authority questions.
  • Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship


Degree Requirements

PharmD/PhD in a relevant scientific discipline, or MS/BS

Experience Requirements

A minimum of 3 years (MS) to 5 years (BS) of experience in regulatory documentation or equivalent. All PhD in biological sciences and PharmD candidates will be considered.

Key Competency Requirements
  • Demonstrated strong writing skills in authoring and managing the production of scientific documents (pharmaceutical regulatory documentation and/or publications in peer-reviewed journals).
  • 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.
  • Experience writing and managing the production of clinical documents; knowledge of regulatory documentation principles and processes.
  • Good knowledge of drug development process (preferably clinical development).
  • Understanding of documentation requirements related to regulatory filings.
  • Worked successfully in a cross-functional project team; ability to facilitate discussions and decision-making with cross-functional team members


Travel Required

None

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

None

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.