The Business Consultancy Expert enables global CTSU to manage innovation and improvement projects across all sites and time zones using local and global subject matter experts to achieve efficient and rapid delivery of objectives, with minimal supervision and general direction. This role provides full support for FDA and authority inspections and can help provide timely response to questions and tasks, additionally acting as a host for local GMP and self-inspection topics and support the timely provision of information for these audits. Additionally, this position enables effective vendor management specifically towards US based organizations organizations.
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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities\:
- Responsible for creating system and training for all CTSU staff and team leaders, to provide consultancy and advice regarding the compliance status of the work undertaken within the department.
- Individually develops strategic approaches and processes which are compliant to the regulations of all health authorities worldwide.
- Collaborates across all CTSU functions and with global business partners to ensure that CTSU successfully passes all audits and inspections conducted by the Pharmaceutical Regulatory bodies worldwide.
- Drives the culture of innovative developments and Continuous Process Improvements (CPI) by taking the project leader role.
- Responsible for set-up and organization of project teams, writing of project charters, and organization of regular steering committee meetings, negotiations with process owners and presentations to managers and staff of milestone achievements; this is expected to be achieved with minimal supervision and direction.
- Projects include a strong focus on patient experience and improvements to existing and established processes.
- Challenges existing business models and act as a coach and trainer during rollout and implementation stage.
- Responsible for the strategic management of existing vendor partners and introducing new vendors to shape the future of the business and meet the changing outsourcing opportunities of future work packages.
- Ensures the CPI philosophy is acted upon in all CTSU work packages performed at the vendor and that strategic issues are dealt with in an efficient and timely manner.
- Works together with GSPC, Sourcing and Q&RM to provide an aligned business on behalf of the Pharmaceutical Development Department.
- Provides coaching to staff and Managers through presentations, short seminars and in workshop environments on Business related Soft Skill topics.
- Works independently to provide process related support to CTSU staff and Managers with the introduction of new or redefined processes via presentation, workshops or 1\:1 training to ensure transitions of work packages results in minimal disruption to the process and an intuitive workflow for staff and managers.
- Interfaces internally with Clinical Operations including negotiations related to budget, resources, and timelines for innovative development.
- External interfaces include major vendors for performance and quality standards, regulatory authorities to provide guidance and on occasions lobby for regulatory changes and occasionally with other Pharma Group Executives for focus group meetings.
- Leadership responsibilities are related to the management of project teams of up, to 8 experts and Department Leaders and specialist SME's (subject matter experts).
- Master's Degree and six-plus (6+) years experiences in a related scientific discipline.
- Demonstrates knowledge of all areas of clinical supply chain activities.
- Thorough knowledge and understanding of applicable US and EU regulations.
- Ability to learn new technologies and concepts to enhance operations.
- Recognized project management qualification.
- Proven ability to drive results in a changing environment.
- Excellent presentation skills.
- Fluent in English for both daily and technical language, a basic knowledge of German would be an advantage.
- Willingness to travel within the USA and occasionally within Europe.
- Demonstrates a high standard of GMP and GCP knowledge; all work undertaken must be compliant to the regulations of MHRA, EMEA and FDA authorities.
- Exhibits the ability to expound complex project requirements and can interpret highly complex experimental data and relate this to project requirements.
- Demonstrates effective communication orally, in writing and via presentations.
- Proven ability to present complex projects / status reports, break down the important factors and explain to a varied audience.
- Ability to work independently and in teams, and drive finalization of decisions.
- Must have a motivational character towards project team members, setting goals, clear expectations and holding those members accountable for timely delivery.
- Functional knowledge of the clinical supply process for IMP, AxMP, commercial comparators and auxiliary clinical devices.
- Business knowledge of project leadership via six sigma, Agile and other methodology.
- Product knowledge of major IMP products and the relevant distribution parameters and market knowledge of the major activities undertaken by our business competitors.
- 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.
- This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Click here for more information on the vaccine mandate and COVID-19.
Who We Are\:
At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family-owned company, we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative, and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.