Bristol Myers Squibb Hiring for GCC&CI REGIONAL CLINICAL COMPLIANCE LEAD at Hyderabad, India Full Time

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 .

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.

Functional Area Description

The Regional Clinical Compliance Lead (RCCL) role is placed within the Global Clinical Compliance & Continuous Improvement function of Global Development Operations (GDO) and reports to the Head of Regional Clinical Compliance of the respective Region.

This role will support and enable corporate GDO objectives by: the planning, preparation and execution of Compliance Assessments; Risk and Issue identification and management support at a Country, Cluster, and Regional level; supporting the delivery of the GDO audit management plan, ultimately with the aim of ensuring GDO is inspection ready at all times.

Position Summary

• This role will operate in partnership with GCCCI, Global Quality, Regional Clinical Operations, et. al. to promote and foster a regional, cross-functional mindset of Quality Excellence and Quality by Design, ultimately to ensure GDO is inspection ready at all times.

• This role will interact with the Global Quality Function in support of sponsor inspections and activities within the local markets. There will require a significant partnership with the Global Quality organization.

• This role requires expertise in Good Clinical Practice (GCP), ICH and Health Authority policy and guidelines to facilitate compliance for clinical trials delivered within the Region.

• This role has primary responsibility for the selection and conduct of Compliance Assessments to support clinical teams with the identification, management, resolution and documentation of compliance issues and quality improvement.

• This role will support BMS-Sponsored interventional studies (Phase I-III), operationally managed by BMS. (Exceptions to support trials outside this scope may be made subject to business risk and resource availability.)

Position Responsibilities

• Support Regional study teams and sites, in partnership with RCO and Global Quality Clinical Trial & Safety (CT&S), to ensure inspection and audit readiness at all times.

• Take responsibility to create and maintainan annual Compliance Assessment Schedule.

• Select Compliance Assessment targetsin a data driven, risk-based manner. Targets may include processes, studies, or sites.Compliance Assessments will not be conducted on CT&S audit targets.

• Conduct Compliance Assessments remotely (by desktop). Compliance/Health visits may be conducted on-site where the risk is sufficiently high or compliance cannot be assessed remotely.

• Report Compliance Assessments outputs to in scope stakeholders; Observations/findings will be assigned owners, due dates and tracked to closure.

• Ensure Training, Communication and Continuous Improvement needs are developed, in collaboration with stakeholders, such as Medical, Legal or Regulatory, Safety, Business Insights & Analytics, and Development, to ensure compliance concerns are addressed.

• Communicate best practices, lessons learned, observations and findings, global and industry trends, etc… etc…, with support from RCO, within an appropriate Forum.

• Support the end-to-end issue management process (GCP-related) at site, country and regional level throughout the study(after process review [policy/SOP] and line manager consultation).

• Partner with the GCC&CI organization & RCO to identify regional training needs, process improvements, and provide, or facilitate, local training, as needed.

• Monitor local regulation updates and initiatesubsequent PEARL submissions, where applicable (in some Countries this can be a GRS responsibility). Support subsequent procedural, GCP-related local training and communication as necessary

• Support RCO in CAPA management process by driving Root Cause Analysis and CAPA development, follow-up of regional/site-level CAPA till closure.

• Inspection Support: Provide Training for GDO inspection management. In collaboration with CT&S, coordinate site and sponsor inspections by Health Authorities depending on the Inspection type

Degree Requirements

• A minimum of a Bachelor’s Degree (or equivalent) is required. Degree in a LifeScience or equivalent is preferred.

Experience Requirements

• At least 5 years of experience in clinical trial operations and/or GCP is required.

• Strong knowledge of the global drug development process and clinical operations. Experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies, as well as Corrective Actions and Preventive Actions is required.

Key Competency Requirements

• Experience in matrix management and training is desirable with the ability to engage and inspire others.

• Good communication skills with a proven ability to effectively engage and manage key internal stakeholders (in various functions and geographies) as well as external stakeholders (including Health Authorities).

• Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner with a cross-functional team.

• Ability to manage multiple projects simultaneously to ensure timely, execution of tasks.Attention to detail with excellent planning, time management and organizational skills.

• Ability to drive and manage issue escalation.

• Have a strategic mindset to translate local needs into effective regional country compliance oversight plans.

• The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.

#HYDDD

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™ ”, 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

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 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/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

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.

Company: Bristol Myers Squibb

Req Number: R1569021

Updated: 2023-05-03 03:44:23.391 UTC

Location: Hyderabad,India

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.