Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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: .

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

Leads regulatory document quality review strategy and coordination in support of registrational clinical trials and submissions in key markets. Provides support for regulatory documents (protocols, clinical pharmacology, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline.

Position Summary / Objective

Provides strategic direction toward development of document quality review processes and implements documentation standards that support quality and speed of regulatory submissions, clinical protocols and periodic reports across all full development / life cycle management assets and geographies. Provides project management in quality review process development, working practice maintenance, external provider oversight and continuous improvement initiatives.

Position Responsibilities

• Provide leadership and strategic direction in designing and implementing an integrated business model for documentation quality review across document types.
• Drive the development and manage the implementation of regulatory documentation quality review processes to meet time and quality performance goals for clinical protocols, clinical study reports, submission documents and periodic reports.
• Develop and maintain quality review working standards including checklists, scorecards, process job aids and training requirements to ensure high quality and consistent review practices.
• Coordinates relevant document sub team meetings to ensure effective planning, utilization and performance of external quality review providers.
• Lead and implement change initiatives to achieve continuous improvement in quality review processes. Utilize metrics to identify and prioritize process improvements that increase quality review efficiency while maintaining documentation standards.

• Maintain awareness of evolving regulatory guidance\xe2\x80\x99s, best practices and technology and channel appropriate intelligence into the quality review business model.

Degree Requirements

Minimum of a Bachelor degree (BA/BS) in a scientific discipline or related field. Master\'s Degree and PMP certification strongly desired.

Experience Requirements

Minimum of a Bachelor degree (BA/BS) in a scientific discipline or related field. Master\'s Degree and PMP certification strongly desired. At least 7 years\' pharmaceutical industry experience including 5 years within regulatory documentation.

Key Competency Requirements

• Thorough understanding of regulatory document quality review standards and processes. Direct experience in leading workstreams for design and implementation of quality review processes for regulatory documents.
• Strong project management skills with proven record of accomplishment in managing cross-functional teams, project workstreams and continuous improvement initiatives.
• Proven track-record in collaborative sponsor/vendor relationships as a sponsor vendor manager or as a CRO account/workstream lead. Experience in vendor oversight, resource planning and budget management.
• Knowledge and prior experience in protocol, clinical study report, investigator brochure and safety aggregate report authoring processes and quality review requirements.
• Knowledge of submission readiness and eCTD formatting requirements for regulatory documents.
• Working knowledge and direct experience with electronic document management systems (EDMS) for document authoring, review and storage of regulatory documents.
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.
• Demonstrated innovation, flexibility, resilience, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.

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If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 . Visit 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.

Bristol-Myers Squibb