Scientific Writer

**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.

**Position Purpose**

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.

**Key Responsibilities**
- Author regulatory documents [eg, Investigator's Brochures (IB), development safety update reports (DSUR), periodic benefit-risk evaluation reports (PBRER), Risk Management Plans, (RMPs), Protocols, Clinical Study Reports (CSR), responses]
- good documentation principles (organization, clarity, scientific standards).
- consistency between text and tabular presentations or graphical displays.
- BMS documentation standards and worldwide regulatory requirements.
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells.
- Comply with internal and external processes and guidelines while managing the document review process.
- Resolve issues, errors, or inconsistencies with pertinent team members to ensure:

- optimal communication between authoring team and development team members.
- coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation.
- timely completion and high quality of assigned documents.
- Review and edit documents.
- Serve as a liaison for external documentation support (when required), prepare specifications for the work, and ensure maintenance of good documentation principles as well as BMS documentation standards.
- Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

**Education requirements**
- PhD/MD/PharmD or MS/BS with prior experience

**Experience Requirements**
- Demonstrable experience of pharmaceutical regulatory documentation.

**Key Competencies**
- Demonstrated exceptional writing skills in authoring and managing the production of IB, Safety Aggregate Reports, Clinical Protocols, and/or CSRs.
- 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.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
- Working knowledge of a document management system and basic knowledge of the document publishing process.

LI-Hybrid

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

Bristol Myers Squibb is Disability Confident - Committed

A UK Government scheme