Principal Scientist Nonclinical Safety Writing
Principal Scientist Nonclinical Safety Writing
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Job Description
Working with Us
Challenging. Meaningful. Lifechanging. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside highachieving 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: 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 INDs 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 highquality documents and review and understand nonclinical study reports. Experience in global regulatory practices and guidances 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 fastpaced and exciting environment as we bring novel therapeutics to patients.
Key Responsibilities
Partner with Project Toxicologists and other nonclinical SMEs to author review and/or track regulatory documents. This would include but is not limited to INDs CTAs FastTrack CTAs (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 SMEs 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
Firsthand 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 inhouse 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 selfadvocate 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 doesnt 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 Lifechanging 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.
Onsite Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes siteessential sitebydesign fieldbased and remotebydesign jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Siteessential roles require 100 of shifts onsite at your assigned facility. Sitebydesign 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 fieldbased and remotebydesign 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 . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your wellbeing and the wellbeing of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid19 and keep up to date with Covid19 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Staff IC
Employment Type
Full-Time
