Principal Scientist, Nonclinical Safety Writing

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

This position is for a Principal Scientist working in the Global Nonclinical and Scientific Documentation (GNSD) group. Our group partners with nonclinical scientists in toxicology, DMPK and pharmacology to assist in the preparation and review of global nonclinical regulatory facing documents including IND's, marketing applications, health authority briefing documents, and addressing queries amongst other activities. GNSD supports all drug development programs in the BMS pipeline from candidate nomination to global approval.

We are seeking a talented individual with a strong scientific acumen to collaborate with our toxicology colleagues supporting Global Project Teams. The successful candidate will work on multiple programs across various therapy areas and modalities that may include small molecules, large molecules, and cell therapies. This role requires excellent organizational and communication skills, the ability to author high-quality documents, and review and understand nonclinical study reports. Experience in global regulatory practices and guidance's for nonclinical drug development and submissions is preferred. Additionally, the candidate will take an active role in optimizing regulatory submission processes and improving our global document practices. This offers a great opportunity to engage in many aspects of drug development in a fast-paced and exciting environment as we bring novel therapeutics to patients.

Key Responsibilities

• Partner with Project Toxicologists and other nonclinical SME's to author, review and/or track regulatory documents. This would include but is not limited to INDs, CTA's, Fast-Track CTA's (France), NDAs, MAAs, BLAs, CTD, IBs, etc. Developing and maintaining timelines for these deliverables is critical.
• Work on multiple projects across all modalities including small molecule, large molecule and cell therapies.
• Support the Project Toxicologist and other nonclinical SME's in addressing Health Authority questions.
• Complete regular document updates such as IB, DSUR, ODAR etc.
• Track documents through review cycles. Attend and contribute to departmental and group meetings.
• Understand the impact of Toxicology on other functions within the company such as Pharmacology, DMPK, Clinical and CMC and lead initiatives to improve regulatory submission processes across the company.
• Other duties related to the above, as assigned.

Qualifications & Experience

• Applicants with a Ph.D. in an appropriate life sciences discipline preferred
• Pharmaceutical/biotech industry experience in the field of Toxicology >4 years
• First-hand experience as lead author on writing documents for nonclinical scientists to be submitted to global regulatory agencies such as those listed above.
• Strong PC experience:
• Training on in-house document repository system will be provided.
• Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.
• Must be flexible and adaptable to changing project priorities and work assignments.
• Must have strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required.
• Careful attention to detail and quality are essential.
• Excellent scientific written and verbal communication skills required.
• An appreciation of artificial intelligence large language model use for document authoring is a plus

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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