Medical and Regulatory Affairs
At BMS, we participate in the delivery of cutting edge immuno-oncology treatments. These new options have to potential to transform the treatment, and lives, of cancer patients worldwide. As our book of work continues to grow, so must our team of experienced scientific writers.
With minimal supervision, write and edit clinical documents needed for regulatory purposes (eg, protocols, study reports, high level summary documents, Investigator Brochures, briefing documents) for submission within established timelines to support the goals of the R&D development team.
Serve as lead writer for at least one compound.
Provide support and instruction to junior members of department.
Integrate a large quantity of information to create concise, clear, consistent, readable documents.
Ensure that assigned documents accurately reflect the data provided and are consistent, clear, adhere to guidelines, and conform to project-specific standards.
Understand statistical results and use this knowledge in preparing documents.
Gather background information, data, previous samples of similar documents, etc., to prepare for writing task.
Help teams define content for standard regulatory documents.
In accordance with the SOPs and related work practice documents, manage the processes for document preparation within established timelines.
Follow the Core Template, other Model Documents, departmental guidelines for specific documents, and ICH and health authority regulations in the preparation of documents.
Together with the Dossier Management Group, coordinate the distribution, review, and approval process for assigned documents.
Work effectively with the Document Publishers to ensure that all appendix materials are available at the required times.
Exhibit reasonable mastery of the electronic environment in which documents are produced, e.g., Microsoft Word, PowerPoint.
Use CARA (Constellation Authoring, Review and Approval system) according to company policy as the docbase for all regulatory documents.
Follow applicable Best Practices to maintain integrity of electronic and paper files and version control.
As assigned, perform quality review of 1) documents written by other writers and 2) materials submitted by other functions for incorporation into documents to ensure accuracy, consistency, clarity, and appropriate adherence to guidelines.
Prioritize assignments with guidance.
Be familiar with the drug development process, and the content/document requirements of clinical portion of regulatory submissions.
Increase understanding of experimental design including selection of treatments, randomization of treatments, and specification of measures of effect.
Coordinate comments and resolve issues diplomatically within the teams.
Provide administrative information to maintain the document tracking system.
Work effectively in multi-functional teams.
Maintain confidentiality of sensitive information.
Provide feedback and/or leadership, as appropriate, in the Documentation Subteams particularly in regard to document creation and establishing timelines.
Demonstrate mastery in preparing standard regulatory documents such as Phase 1/2 CSRs, protocols, and IBs.
PhD, PharmD, MS, or BS in a relevant scientific discipline with a minimum of 3-4 years (PhD, PharmD), 5 years (MS), or 7 years (BS) of experience in regulatory documentation/scientific writing or equivalent
Demonstrated strong writing skills as evidenced by good quality writing in publications in peer-reviewed journals or in pharmaceutical regulatory writing
Analyzed and interpreted 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
Knowledge of regulatory documentation principles and processes and of the drug development process (preferably clinical development)
Solid understanding of documentation requirements related to regulatory submissions and approvals
Worked successfully in a cross-functional project team; ability to facilitate discussions and decision-making with cross-functional team members
The positions are office-based in the Princeton, NJ area.