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Biogen Associate Director, Global Regulatory CMC Systems and Tools Lead in Cambridge, Massachusetts

This global position can be based in one of Biogen’s locations: Cambridge, MA or Maidenhead, UK* *

This role is responsible for the development, implementation, and oversight, of global regulatory CMC (RegCMC) systems and tools. Responsibilities include learning, influencing, and preparing for the application of new and future tools, systems, and information management technologies. This candidate must have proven leadership and abilities to work cross-functionally and cross cultures. Strong communication and interpersonal skills are required. The role is situated within the ‘Global regulatory CMC Strategic Operations’ team that supports a global department of 50 in all strategic operations work. The focus of this role will be on the regCMC strategy and functional support for information technology. Close partnership with the regCMC IT lead will be essential and support from this lead will be available for the technical IT aspects.* *

Duties and Responsibilities:

· Leads Global Reg CMC technology information strategy from a functional perspective and translates into implementable plans.

· Liaises with PO&T IT and R&D IT on regCMC functional needs and strategy to gain appropriate support in building the infrastructure. In addition, provides consult on Global Regulatory CMC business processes to the IT teams as needed.

· Maintains an inclusive, global approach to creating standardized ways of working.

· Responsible for strategy, development and implementation of systems, and tools useful for creating efficiency and accuracy in Global Reg CMC submission preparation.

· Maintains Global RegCMC Sharepoint site, incorporating strategy in design.

· Represents RegCMC in wider Biogen working groups and cross-functional system sub team meetings, influencing adoption of technology and processes which align with RegCMC priorities and business processes.

· Maintain up to date knowledge on Agency requirements for digital strategy, IDMP and other policies, requirements or regulations impacting information technology.

· Participates in UAT testing of relevant systems, providing RegCMC insight into creation of test scripts.

· Preparation and maintenance of SOPs, work instructions, and training materials within the scope of systems and tools and execution of trainings for department members and key stakeholders in collaboration with the IT RegCMC Lead.

· Accountable for ensuring that tools and systems are maintained as global and contemporary using standardized, continuous improvement and LCM practices.

· Works closely with the Global Regulatory CMC Knowledge Management lead to optimize ontology of systems, compliance of system use and suitability for knowledge management purposes.

· Development of meaningful reports and metrics for performance within systems and compliance activities across the Reg CMC department at all sites and with consultants in collaboration with the IT RegCMC lead.

· Supervises consultants as applicable to ensure operational system activities are performed appropriately, designs required KPIs to track performance as applicable.

· Supports development and enhancement of inter departmental dashboards, flows and other functionality from the Microsoft power apps in close collaboration with the Global RegCMC Business Operations Lead and the IT RegCMC Lead.

· Provides information/input/reports to the Global RegCMC Leadership team as required.

· Partners with GSRS on submission related systems, tools, and initiatives to enhance connectivity.

Key Contacts and Interactions: Ethically interacts with multiple international, cross-functional departments, and industry peers at all levels.* *

Customer focused: Interacts with a wide variety of outside contacts, including contractors, corporate partners and regulatory agency personnel.* *

Position Impact:

Affects other departments and/or corporate projects and ultimately compliance and quality of product submissions, facility registrations, and continued patient supply. Fulfillment of responsibilities supports attainment of team and/or departmental goals. Errors may result in delays to project timelines and product and site facility registration/compliance and product supply.

_Regulatory Skills_

· At least 5-7+ years strategic global regulatory CMC industry experience, including management of regulatory systems and tools

· Proven demonstration of successful leadership in development & implementation of regulatory systems and tools.

· Knowledge and experience in interpretation of global/international guidance, regulations, policy statements, etc.

· Extensive experience with use and development of a wide variety of standard regulatory information systems and tools.

_Leadership/Management Skills_

· Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

· Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.

· Demonstrated strategic thinking and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.

· Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths; delivering projects with agility, on time and on budget.

· Proven ability for optimism and energy in the face of change and adversity.

· Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with both business priorities and system needs.

· Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.

· Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively, and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.* *

Preferred/Additional: Recognized experience in utilizing IT solutions for project and timeline management.* *

Education: BS University degree in Life Sciences, Engineering, Information Technology, or relevant Pharmaceutical Science; Graduate degree preferred.

This global position can be based in one of Biogen’s locations: Cambridge, MA or Maidenhead, UK* *

This role is responsible for the development, implementation, and oversight, of global regulatory CMC (RegCMC) systems and tools.

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