Job Description

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 rich in diversity. 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 .



Key Responsibilities



Responsibilities include coordination of study-level safety narrative production:• To maintain a well-defined narrative book of work as aligned with departmental scope of deliverables (eg, Phase 1-3 Clinical Study Reports [CSRs] and within registration procedural Health Authority requests).
• To plan, track (maintain metrics), and ensure sufficient resources for the preparation of safety narratives for clinical studies. Manage staff resourcing against BOW deliverables achieving project timeline and maintaining quality standards.
• Management of a team of narrative writers including personnel training, objectives setting, performance check-ins, development planning and year end processes.
• Management and oversight of narrative production process from initial drafting through incorporation into the CSR, preparation of specifications for work assigned, and maintenance of good documentation principles as well as BMS documentation standards.
• Comply with internal processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure:
+ optimal communication between narrative production team and development team members
+ timely completion and high quality of study-level safety narratives
• Review and edit safety narratives ensuring quality and compliance as required.
• Participate in training of program teams including procedures and standards to ensure quality and consistency while meeting CSR timelines.
• Collaborate with study-level roles to ensure effective planning and timeline adherence for all safety narrative projects.
• Influences a diverse group of contributors to safety narrative production from a variety of disciplines without a reporting relationship.
• Maintain awareness of evolving regulatory guidance's, best practices and technology and channel appropriate intelligence into the narrative authoring business model.


Qualifications & Experience• PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5-10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.
• Demonstrated people management skills with experience in hiring, training, retaining, and developing staff.
• Experienced in project and resource management including schedule of work, timelines, and quality assurance using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
• Demonstrated strong writing skills in authoring and managing the production of clinical and regulatory documents.
• Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• Working knowledge of a document management system and basic knowledge of the document publishing process.
• The position is not a remote working opportunity.

Why You Should Apply



Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.



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.



#HYD



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(TM) , 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.



On-site Protocol



BMS 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:




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.



Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.