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Bristol Myers Squibb

Associate Director, Submission Management

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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 .

Position Summary

The Associate Director manages and coordinates the timely, compliant, and accurate delivery of submissions to health authorities.

Position Responsibilities

  • Manages the activities and deliverables for the local submission teams delivering global health authority submissions for BMS products in a matrix environment
  • Provides guidance and mentoring regarding regulatory/submission requirements, strategies, content, and format based on knowledge of submissions for global markets
  • Provides feedback, coaching, and training needs for team members and encourage career development.
  • Utilize tools to enable proper resource allocation and demand management across local teams in support of the BMS book of work
  • Sets performance standards, captures metrics, and helps the team work through challenges to achieve goals
  • Drives innovation and continuous improvement in technology and submission processes; supports and develops new ways of

working.

  • Leads projects and other quality improvement initiatives for the department
  • Supports due diligence activities, document and submission management for acquisitions, partnerships and divestitures.
  • Participates in the Health Authority guidance and regulation updates and impact on the organization.
  • Facilitates cultural and logistical needs for a global team
  • Develops and updates procedural documentation as needed.

Degree Requirements

BA/BS degree, science / technology field preferred.

Experience Requirements

7+ years relevant submissions experience.

Key Competency Requirements

  • Expert knowledge of global regulatory practices, submission guidelines and requirements.
  • Anticipates and resolves complex issues at the cross-functional level.
  • Generates alternative solutions by weighing risks and considering dependencies.
  • Support of other RISM members sharing expertise, providing guidance and serving as a SME/mentor.
  • Excellent command of the English language, and able to communicate effectively in both written and oral forms.
  • Simplifies complex issues or topics to design clear and impactful presentations, sessions, or workshops.
  • Leverages project management methodologies and lessons learned from prior experience to optimize portfolio, program, and project execution.
  • Drives and facilitates risk-mitigation strategies and contingency plans with key stakeholders. Facilitates change management and ensures business adoption/implementation of the plan.
  • Prioritizes and manages multiple complex projects or programs. Determines and manages resources and tracks metrics and budget needs, as applicable.
  • Subject matter expert who thinks strategically and is able to make decisions in alignment with group/company objectives.
  • Leverages collaborative relationships to address complex or sensitive issues and resolve conflict.
  • Drives discussions with functional leads to define and align on objectives for cross-functional and enterprise initiatives.
  • High proficiency with desktop application software suites, including effective troubleshooting skills.
  • Knowledge and subject matter expertise with computer systems in an R&D environment.

Travel Required (nature and frequency).

5%.

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

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 [Confidential Information] . 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/

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

More Info

Industry:Other

Function:Pharmaceuticals

Job Type:Permanent Job

Skills Required

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Date Posted: 24/11/2024

Job ID: 101335677

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