RA US Operations Excellence Manager

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The primary focus of the RA US Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic and operational initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving current processes and establishing organizational procedures to optimize workflows, key metrics, efficiency and productivity that influences the day-to-day submission operations of GI USA RA region. This role will also be the KEY GI technical expert managing controlled documentation and training programs for the GI USA RA region.

Duties & Responsibilities

• Responsible as direct contributor for planning and tracking the submissions of Parasitology, Non-Infectious and Infectious Disease projects For Regulatory Affairs.
• Ensures alignment and compliance with Governance and RA submission processes.
• Maintains the proper controls to ensure that the reports, metrics and KPIs are reflective of operational environment.
• Ensures processes supporting KPIs/metrics for network agility and efficiencies are not compromised.
• Accountable and responsible for supporting RA leader by reflecting the regulatory submission timing needed for project program.
• Fosters strong collaboration with RA team members and leaders to ensure data integrity and readiness are reflective in RA KPIs/metrics and respective IT platforms for adherence to submission processes.
• Directly responsible for generating communication of the USA RA Dashboard into a broader communication package containing, Deliverables, Key Messages or Roadmaps, and compliment communication elements to illustrate vision or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC, Corporate Affairs or regulatory agencies.
• In partnership with RA project team members, helps drives cross functional engagement and alignment on regulatory workflow or compliance of processes across GI, including but not limited to relevant project deliverables or operational outcomes.
• Outcomes will be driven cross functionally within the GI US regions with clear roles and accountabilities.
• Supports the USA RA organization in preparing connectivity to Global RA strategy and annual objectives as well as USA CMC annual objectives by translating KPIs/Metrics into reportable Dashboards.
• Ensures that the appropriate agenda topics regarding processes and submissions outcomes are discussed and actions at USA RA Leadership Team meetings, or related team meetings, and ensure successful preparation and follow ups on action items.
• Responsible as ad hoc member to task force or project teams as required by RA functions to address process/workflows/documentation to regulatory agencies aimed to influence optimum Regulatory awareness, improved documentation, reporting efficiency to drive submission with reduced review time and increase approvals.
• Participates as an active member of the USA RA leadership team, and appropriate USA RA Committees.
• Provides leadership, organization and strategic focus to the daily operation of the USA RA organization.

Requirements

• Bachelor’s degree or higher from an accredited institution required or greater.
• Minimum five (5) years’ experience in pharmaceutical industry, with preferred experience in animal health environment. PMP or Operational excellence certificate or similar is preferred.
• Sound knowledge of science and the pharmaceutical (NCE, NBE, vaccine) development process with the ability to drive collaboration across cross-functional teams.
• Entrepreneurial spirit, self-starter with excellent skills in interpersonal communication, working with senior leaders, maintaining confidentiality, organization, customer focus, integrity, teamwork and time management.
• Ability to build relationships at all levels of the organization and become a discussion partner and trusted advisor on a broad range of management topics.
• Value diversity and inclusion/cultural awareness.
• Strong facilitation skills and problem-solving skills.
• Excellent communication skills, both written and oral.
• Ability to understand, influence and motivate personnel in a matrix organization and be able to work efficiently under pressure.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

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