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Bristol-Myers Squibb

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4.0

based on 128 Reviews

116 Bristol-Myers Squibb Jobs

Associate Director, Submission Management

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

4.0

based on 128 Reviews

5-8 years

Hyderabad / Secunderabad

1 vacancy

Associate Director, Submission Management

Bristol-Myers Squibb

posted 1mon ago

Job Role Insights

Flexible timing

Key skills for the job

Project Management Data Privacy Change Management Clinical Trials Financial Due Diligence Troubleshooting

+ 4 more

Job Description

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.