Scientific Writer At BMS, we are fortunate to 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. Primary Responsibilities
- Under supervision of a senior member of the department, write and edit clinical documents needed for regulatory purposes (eg, protocols, study reports, Investigator Brochures) for submission within established timelines to support the goals of the R&D development team.
- 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.
- With appropriate guidance, define document content.
- 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.
- Learn to prioritize assignments with guidance.
Develop familiarity with the drug development process, particularly a thorough knowledge of the structure of essential clinical documents.
- Develop an understanding of experimental design including selection of treatments, randomization of treatments, and specification of measures of effect
- Develop ability to 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.
- PhD, PharmD, MS, or BS in a relevant scientific discipline with a minimum of 1-2 years (PhD, PharmD), 2 years (MS), or 5 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.
Note: The title of the role will be determined by the qualifications and experience of the candidateQualifications:
Candidate should be qualified with Bachelors(Required),Qualifications like Doctorate,Masters,Pharmacy,Physician,Veterinary_Medicine would be a pro.Candidate should have the ability to speak English.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.