Senior Scientific Writer I

Working with Us
nChallenging. 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 rich in diversity. Take your career farther than you thought possible.
n
nBristol 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 .
n
nPosition Summary
nTo coordinate and author complex documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
n
nKey Responsibilities

• nAuthors complex clinical documents [eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries] for timely submission to health authorities worldwide according to:
  • ngood documentation principles (organization, clarity, scientific standards)
  • nconsistency between text and tabular presentations or graphical displays
  • nin compliance with BMS documentation standards and worldwide regulatory requirements
• nParticipate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
• nParticipate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• nParticipate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells.
• nComply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure:
  • noptimal communication between authoring team and development team members
  • ncoordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation
  • ntimely completion and high quality of assigned documents
• nReview and edit documents as required.
• nServes as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.
• nLeads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

nQualifications & Experience

• nPharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.n
• Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR.
• nDemonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
• nGood understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• nDemonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

nWorking knowledge of a document management system and basic knowledge of the document publishing process.
n
nIf 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.n
n
nUniquely Interesting Work, Life-changing Careers
nWith 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 an inclusive culture, promoting diversity 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.
n
nOn-site Protocol
n
nBMS has a diverse 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:n
n
nSite-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.n
n
nBMS 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 [Confidential Information] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.n
n
nBMS 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.n
n
nBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
n
nIf 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/n
n
nAny data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.