Full-Time

Principal Scientist

Nonclinical Safety Writing

Confirmed live in the last 24 hours

Deadline 6/23/25
Bristol Myers Squibb

Bristol Myers Squibb

10,001+ employees

Develops and delivers biopharmaceutical medicines

No salary listed

Senior

Company Historically Provides H1B Sponsorship

Franklin Township, NJ, USA

Category
Editing & Proofreading
Technical Writing
Content & Writing
Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
Requirements
  • 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
  • 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
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
Desired Qualifications
  • An appreciation of artificial intelligence large language model use for document authoring is a plus

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, particularly in oncology, immunology, and cardiovascular health. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs that are affordable alternatives to their innovative medicines, ensuring they meet high quality and safety standards. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, as well as its commitment to sustainability and corporate responsibility. The company's goal is to improve patient outcomes by providing effective and affordable healthcare solutions while adhering to Environmental, Social, and Governance (ESG) principles.

Company Size

10,001+

Company Stage

IPO

Headquarters

New York City, New York

Founded

1887

Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with BioNTech enhances BMS's oncology portfolio against competitors like Merck.
  • Chris Shibutani's appointment may drive strategic growth and innovation at BMS.
  • $40 billion US investment shows BMS's commitment to long-term growth and innovation.

What critics are saying

  • Heavy reliance on real-world data may affect drug approval if data quality falters.
  • $11.1 billion BioNTech partnership could strain finances if results are underwhelming.
  • Recent layoffs may impact operational efficiency and employee morale at BMS.

What makes Bristol Myers Squibb unique

  • BMS focuses on oncology, immunology, and cardiovascular diseases for innovative treatments.
  • The company integrates real-world data to enhance drug development and patient outcomes.
  • BMS offers both innovative and generic medicines, increasing healthcare accessibility.

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Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Company News

ROI-NJ
Jun 13th, 2025
Bristol Myers Squibb Names Shibutani As Evp, Chief Strategy Officer

Bristol Myers Squibb (BMS) this week appointed Chris Shibutani as executive vice president, chief strategy officer, effective immediately. Shibutani’s role is a new position on the BMS leadership team. The announcement was made on a LinkedIn post.Shibutani will lead the development and advancement of the company’s long-term strategic plan, collaborating across the enterprise to drive innovation and growth. He brings more than 25 years of experience in the financial services industry covering global pharmaceutical, biotechnology and medical device industries.Prior to BMS, Shibutani served as managing director in the global investment research division at Goldman Sachs. Previous roles include senior analyst positions at Hambrecht & Quist, Cowen, UBS, and J.P. Morgan.Before his career in finance, Shibutani was a physician trained in anesthesiology and critical care medicine at Massachusetts General Hospital and practiced at Memorial Sloan Kettering Cancer Center

PharmaData
Jun 13th, 2025
Bristol Myers Squibb Highlights Targeted Protein Degradation Data, Including CELMoD Agents, at EHA 2025

Bristol Myers Squibb highlights targeted protein degradation advances, including CELMoD agents and BCL6 Ligand-Directed Degrader, at EHA 2025 in Milan, Italy.

Hit Consultant
Jun 10th, 2025
From Raw Records To Real-Time Insights: Climbing Pharma’S Real-World Data Maturity Curve

Viraj Narayanan, CEO at Cornerstone AI Daniel Lane, Head of RWD Strategy & Operations at Bristol Myers SquibbReal-world data (RWD) has become the pharmaceutical industry’s most promising yet challenging frontier. While companies have long recognized its potential to complement clinical trials and deepen patient outcome insights, many still struggle to fully realize its value.We’ve seen firsthand, from early discovery to market authorization to post-launch evidence generation, that extracting meaningful value from RWD requires more than just data acquisition. It demands a consistent, scalable, and repeatable approach to data quality, as well as a strategic roadmap that moves an organization from minimal use of RWD to a position of true leadership. This journey isn’t simple, but for those committed to navigating it, the competitive advantages are substantial. And, importantly, RWD holds the potential to help bring lifesaving and life-changing medications to market faster and safer than ever before.From Data Collection to MaturityPharma’s growing reliance on RWD has encouraged an influx of partnerships with data aggregators, medical institutions, and digital health platforms. Yet, not all companies are at the same level of maturity in using that data effectively

Devdiscourse
Jun 2nd, 2025
Reuters Health News Summary

Bristol Myers Squibb has agreed to pay up to $11.1 billion to partner with Germany's BioNTech and develop the latter's next-generation cancer immunotherapy, which could take on rival Merck & Co's best-selling drug Keytruda.

The Motley Fool
Jun 2nd, 2025
Why BioNTech Stock Soared Today

BioNTech and Bristol Myers Squibb are teaming up to develop a new cancer drug, BNT327.