Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Senior Scientific Writer - Clinical Study Protocols, ImmunoOncology and/or Specialty
To author clinical study protocols and other related clinical/regulatory documents across multiple phases of development ensuring the coordination and integration of the scientific, medical, statistical, operational and regulatory input from development team members. To support the performance goals (including quality and timeliness) for submission of clinical study protocols worldwide.
Expected Areas of Competence:
1. Coordinates the authoring of high-quality clinical study protocols and other related clinical/regulatory documents (e.g., protocol amendments, revised protocols, administrative letters) across multiple phases of development.
2. Ensures that all assigned documents support the development strategy to achieve team objectives and timely submission in key geographies.
3. Participates in relevant subteam(s) of the development team and ensures effective planning and management of timelines for all components of assigned documents.
4. Leads protocol prototyping sessions including the document flow, logic and consistency for assigned project prototypes; critically reviews project specific model documents, maintains protocol prototypes/shells.
5. Authors complex clinical study protocols and other related documents according to:
a. good documentation principles (organization, clarity, scientific standards)
b. consistency between text and tabular presentations or graphical displays
c. in compliance with BMS R & D documentation standards and worldwide regulatory requirements
6. 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.
7. Excellent oral and written communication skills and comfortable interacting cross-functionally with internal and external stakeholders including physicians, statisticians, document specialists, etc.
8. Able to manage multiple projects and priorities and to shift focus as needed.
9. 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 PRI documentation standards.
10. As required, coordinates writing of responses to health authority questions.
11. Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.
(3-5 pre-hire areas of knowledge)
1. PhD/MD/PharmD in a relevant scientific discipline with a minimum of 1-2 yrs of postdoctoral training, or MS / BS with a minimum of 2 years (MS) to 5 years (BS) of experience in regulatory documentation (preferably in clinical development) or equivalent.
2. At least 3 years of scientific writing experience in preparing clinical, regulatory, and/or registrational documents. AMWA (American Medical Writers Association) and/or BELS (Board of Editors in the Life Sciences) certification(s) desirable.
3. Demonstrated strong writing skills as evidenced by good quality writing in publications in peer-reviewed journals or in pharmaceutical regulatory documentation.
4. Analyzed and interpreted complex data from a broad range of scientific disciplines.
5. Demonstrated ability to work in a cross-functional project team; manage timelines and track deliverables using strong organizational, communication, facilitation and interpersonal skills; proactively identify risks and propose mitigation strategies; facilitate discussions and timely decision-making between authoring and development team members.
6. Familiarity with FDA, ICH, and GCP guidelines for clinical research and data reporting.
(5-7 pre-hire ideal experiences)
1. Experience writing and managing the production of clinical documents; knowledge of regulatory documentation principles and processes.
2. Good knowledge of drug development process (preferably clinical development).
3. In-depth knowledge of the drug development process (preferably clinical development)
4. Understanding of documentation requirements related to regulatory filings.
5. Worked successfully in a cross-functional project team; ability to facilitate discussions and decision-making with cross-functional team members.
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.
Location/Region: Princeton, NJ