Bristol-Myers Squibb Company

Associate Director - Local Representative Market Strategy and Operations

Location
Princeton, NJ, US
Posted
Jun 11, 2018
Ref
R1504975
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

A Local Representative is an in-Country Distribution Customer and/or Service Provider, that also represent BMS in the regulatory, marketing, sales, promotion and/or medical support of BMS products within the appointed country where BMS products are approved. This role will serve as GRS interface between the local country representatives and the global functions providing strategic guidance and operational support to the International regulatory team. The position will report to the Director Strategic Operations International GRS and Local Representatives Markets.

Areas of responsibilities are as follows:

Responsibilities:
  • Serves as Regulatory interface and provides regulatory leadership, support and coordination between third party distributors and BMS functions
  • Support of systems and processes in the geographic area to ascertain timely, efficient, high level regulatory outcomes
  • Supports and controls the regulatory processes in line with business/R&D objectives to ensure timely registration of new products, line extensions and renewals of BMS products with the most competitive label
  • Ensures adequate support for initial filing and subsequent Lifecycle Management and ensures timelines, e.g. translation deadlines to be met
  • Proactively identifies issues and opportunities which require discussion and/or agreement
  • Ensures that appropriate GRS functions are informed about key regulatory milestones and issues
  • Provides planning of submissions in a timely manner
  • Ensures appropriate communication about project status within Regulatory
  • Works closely with other appropriate functions to establish the planning and efficient follow-up of activities.
  • Coordinates requests from respective authorities and provides assessment/guidance to response teams
  • Ensures timely entry of data in the Verity data base by LR Regulatory staff
  • Coordinates specific documentation required by LR authorities for submission
  • Coordinates responses to HA requests
  • Drive current productivity initiatives and develop new continuous improvement initiative
  • Represent GRS International on initiatives aligned with strategy.


This complex and demanding role requires the following skills:
  • Ability to lead strategically and drive performance
  • Good understanding of the drug development process.
  • Good understanding of Global Health authorities regulatory processes
  • Good strategic leadership skills to work both in the corporate and in a cross cultural environment
  • Ability to provide sound regulatory counsel
  • Ability to provide strategic oversight for product-related regulatory challenges
  • Good negotiation skills with 3rd party stakeholders.
  • Ability to deliver concise, effective and persuasive presentations
  • Ability to provide leadership and guidance to regional project teams
  • Strong alignment-building and collaboration skills that allow effective leadership and/or participation in project teams.
  • Proven ability to effectively communicate objectives, activities and results to a diverse audience of functions and regions, at multiple levels.


Requirements:
  • BA/BS degree required
  • A minimum of 6 years of experience in Regulatory at the Local, Regional or Global level or R&D experience in drug development (GDO, RCO, etc.)
  • Experience in project management with the ability to develop clear action plans and execute
  • Ability to represent GRS functions on project team.
  • Experience with understanding multiple local country environments and regulations
  • Ability to translate local regulatory requirement in global action plan