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Job Title

Associate Director, External Affairs

Division

Research and Development / Global Regulatory, Safety and Biometrics / Worldwide Patient Safety/External Affairs

Functional Area Description

The Worldwide Patient Safety group is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, External Affairs and Pharmacovigilance Agreements (PVAs), contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements.

Position Summary / Objective

Drives processes and cultivates relationships that result in the timely development of high-quality PVAs to support BMS commercial licensing and clinical collaborations.

Position Responsibilities

• Has a general understanding, and stays abreast of, current and evolving Regulatory guidelines related to safety reporting for business regions globally, and actively applies such learnings to PVA-related activities
• Reviews and negotiates complex language in assigned contracts, manages sensitive and confidential information, and advises WWPS colleagues on impact of changing regulations and other external influences on safety data contractual obligations
• Builds and maintains strong relationships with other BMS functional areas and business partner representatives to complete and facilitate the implementation of PVAs and ensure compliance with applicable pharmacovigilance requirements
• Serves as a liaison between WWPS headquarters and BMS Local Patient Safety business offices (e.g. PV affiliates) in support of the development of PVAs and related pharmacovigilance activities
• Participates in the coordination and maintenance of data collection and tracking systems associated with business agreements and PVAs, verifying PVA responsibilities with appropriate colleagues in WWPS
• Manages PVA documentation including but not limited to active & terminated agreements as well as PVA implementation notifications. Responsible for initiating PVA implementation checklists.
• Manages/oversees storage and maintenance of PVAs and PVA templates
• Identifies ways to improve productivity and quality standards for PVA-related deliverables and actively participates in efforts to remedy non-compliance situations
• Provides support for development of process flows and work practices to clarify PVA-related systems and procedures to ensure compliance with pharmacovigilance requirements

Version 1.0 Employee Job Profile - Job Descri ption

• Conducts thorough and accurate ana l ys i s of data, gathers cr i t i cal i nformat i on,

effect i ve l y assesses (w i th mana g er) requ i red team resources, and de l i vers qua l i ty so l ut i o n s to cr i t i cal bus i ness tasks

• Works with quality team to provide support and gui dance on PVA related

aud i t/ i nspect i on i ssues. Prov i des subject matter expert i se i n related act i v i t i es. Provi des response on relevant CAPAs

Degree Requi rements

Minimum B.S . Degree (or equivalent, advanced degree or MBA preferred) i n a

re l evant scientific field, such as pharmacy, nurs i n g , or other l i fe sc i ences

Experi ence Requi rements

• At l east 5-10 years of direct relevant exper i ence i n regu l atory, safety, licens i n g , or clinical research function with a pharmaceutical company

• Abi l i ty to part i cipate i n and/or l ead mu l tifunct i onal teams and act as representative i n meet i ngs between BMS and l icens i ng partners
• Demonstrated ab i l ity to read and understand complex l anguage in l egal contracts, manage sens i t i ve and confident i al i nformation, and analyze

complex problems/data

• Exper i ence gather i n g , i nterpret i n g , and apply i ng ex i st i ng and emerg i ng regu l atory gu i delines w i th i mp l i cat i ons for regu l atory approval and drug

safety report i n g

• Demonstrated abi l i ty to work w i th a range of technically and culturally diverse peop l e to meet h i gh quality requ i rements with i n t i ght t i me l i nes
• Strong organizat i onal skills, abi l i ty to hand l e mu l t i p l e project s , and effect i ve l y

commun i cate to d i verse aud i ences at mu l tip l e l evels w i th i n the company and through vari ous formats ( i.e. Presentati ons, written proposals/ reports/correspondence).

Key Competency Requirements

• Strong working knowledge of the drug development process, regulatory guidelines (e.g. FDA, ICH, etc.) relating to pharmacovigilance, and Good Clinical Practices
• Microsoft Office suite
• SharePoint
• Familiarity with web-based systems (LEAD, E-time)

Travel Required

Occasional travel for meetings

Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment

None #HYDDD #LI-Hybrid

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\xe2\x84\xa2 , 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.