The Position

We are seeking a dedicated and innovative professional ready to embrace the challenges and rewards of a key position within our company. As a Capability Manager within the Clinical Documentation Management Capability Area you have the unique opportunity to lead the conception, development, implementation, oversight and continuous improvement of processes, technologies and standards essential for end-to-end management of Clinical Trial Master Files. You combine subject matter expertise, project management as well as leadership skills to translate the capability strategy into actionable plans, manage prioritization and oversee delivery. You safeguard the organization’s needs in alignment with industry best practices and you steer and oversee internal and external partnerships.

At Boehringer Ingelheim, we take pride in fostering a culture of collaboration and innovation and we believe that our employees are our greatest asset. We are committed to creating an environment where you can grow and thrive. If you are ready to take your career to the next level and make a real difference in the world of healthcare, we look forward to hearing from you.

Prepare to expand your skills, ignite your passion for excellence, and make a significant contribution to improving the lives of patients worldwide. Join us at Boehringer Ingelheim - where innovation meets integrity, and where your ideas and dedication truly count.

Tasks & responsibilities

• Shape the future of clinical trials by driving Capability/Project vision and strategy via Capability Area Roadmap Planning, including anticipation of pipeline demands driven by Business Needs and Regulatory Environment.

• Make a global impact by leading project and/or capability teams designing & implementing new systems & processes, ie. coaching/directing team members to design, develop, and implement on time, per budget and meeting defined quality criteria.

• Empower others through your expertise by creating process documentation and training material, implementing processes, coordinating roll-outs, and conducting training activities. Your work will ensure organizational and inspection readiness, and contribute to the growth of documentation management Capability by overseeing external partners, coaching, and mentoring other Capability professionals.

• Steer strategic external partnerships/engagements that are part of a global process environment and system implementation for Trial Master Files und Submission Relevant Clinical Documentation.

• Showcase your analytical skills by identifying and defining business case scenarios and use cases/requirements, providing valuable insights for process improvement and strategic planning.

• Take the lead in overseeing and reporting on process performance, quality, and integrity. You'll use process measures/metrics, system, and support monitoring, and address non-compliance (NC) and CAPAs, including audit and inspection findings.

As a Principal Process Capability Manager you will additionally take over the following responsibilities:

• Drive process excellence by managing highly complex tasks and projects, with an expectation for strategic thinking and action, shaping the broader business strategy, based on your long-term experience in this field.

Requirements

• We're seeking a candidate with a Bachelor´s or Master´s degree in relevant fields such as medicine, science, computer science or business management.

• You should possess a comprehensive understanding of the healthcare, pharmaceutical, and digital/IT industry. A crucial part of this understanding is familiarity with industry regulations and best practices, including industry standards & regulations such as ICH-GCP, Data Integrity Requirements, Good Documentation Practice, TMF Reference Model, and ALCOA.

• Your proven record of successful implementation of business/process/system solutions and change management, preferably in Global settings is required and includes the ability to initiate, plan, execute, control and close projects including reporting on results and/or lessons learned.

• Your Innovative Thinking, your strong desire to know or scout new ways of working and your ability to step back from daily routine and explore ideas for the future in a broader context will be a key asset in this role. You complement this with the ability to actively engage with a variety of stakeholders, build strong customer relationships and delivering customer-centric solutions.

• Being fluent in written and spoken English, including ability for public speaking and presentation to large audiences are a must.

• You should have a natural affinity for data and digitalization, experience with relevant IT solutions used in Clinical Documentation Management and be able to navigate digital environments & data-driven insights.

For the Principal role you should additionally bring the following assets:

• Your strong vision & understanding on how to oversee the most complex process landscape in Clinical Development/Operations is key to drive evolution, including digital innovation.

Ready to contact us?

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com

Recruitment process:

Step 1: Online application - application deadline is 24th May, 2024

Step 2: Virtual meeting starting mid of May

Step 3: On-site interviews starting end of May / beginning of June

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.