Sr Manager, License to Operate & Deputy Information Officer (f/m/d)

Biogen; München; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a strategic thinker to enhance operational excellence within Medical Affairs. This multifaceted role involves overseeing processes, ensuring compliance with R&D QMS, and fostering innovation across functions. You will lead priority projects, collaborate with cross-functional stakeholders, and maintain the integrity of operations. With a commitment to excellence and a pioneering spirit, this biotechnology company offers a supportive environment where individual contributions matter. Join a dedicated team focused on delivering life-changing medicines and making a significant impact in the industry.

Qualifikationen

• 7+ years in the pharmaceutical industry with expertise in QMS.
• Experience in driving operational excellence and process ownership.

Aufgaben

• Oversee Medical Affairs processes ensuring flawless execution.
• Drive process innovation and lead priority projects in Medical Affairs.

Kenntnisse

Strategic Thinking

Operational Excellence

Process Improvement

Leadership

Communication Skills

Ausbildung

Master in Science

Master in Marketing

Master in Economics

Tools

Trackwise

MARS

Vault InSCite

Jobbeschreibung

Job Description

About This Role:
In this multifaceted role, you will be responsible for maintenance and execution of all processes within Medical Affairs according to R&D QMS, ensuring that all activities are delivered flawlessly and within budget. Your oversight will extend to Medical Affairs Research processes, grant operations, and material lifecycle management. As the Deputy Information Officer in Germany, you will foster process innovation across Medical Affairs functions and lead priority projects, working closely with various cross-functional stakeholders. Your efforts will significantly contribute to maintaining the integrity and efficiency of our operations, aligning with our strategic goals and enhancing the value our Medical Affairs team brings to the business.

What You’ll Do:

• R&D QMS, Budget, Medical Affairs Research and Grant operations
  • Act as SME for all R&D QMS processes in medical affairs and within the German process owner network (PON)
  • Guide all CAPA processes in Trackwise with process owners
  • Orchestrate budget execution across all medical affairs functions in close collaboration with Medical Leads and finance function
  • Orchestrate all medical affairs research activities in MARS and ensure always audit ready status of Medical Research activities of Biogen Germany
  • Act as SME of grant operations
  • Responsibility and oversight for KPI tracking and reporting in close collaboration with CE&O
  • Continuously analyze processes, identify gaps and drive process improvement
• Material Lifecycle Management and Medical Affairs Documentation
  • Act as SME for all x-functional partner on Material Lifecycle Management in close collaboration with information officer
  • Responsibility and oversight for KPI tracking and reporting on material life cycle process
  • Continuously analyze processes, identify gaps and drive process improvement
  • Ensure flawless execution of documentation in medical affairs and perform quality checks
• Deputy Information Officer
  • Acts as Deputy Information officer for Non-Promotional and Promotional Material Review
  • Supports development and continuously improves the review process for Promotional/ Non-Promotional/ Medical and Pharmaceutical Materials
  • Conducts trainings on the Material Review process for internal stakeholders
  • Maintains regular best practice sharing with internal stakeholders on the Material Review process
  • Guidance of the local Vault InSCite Champions team.
• Drive Process Innovation and Lead Priority projects in Medical Affairs
  • Driving process innovation across all medical affairs functions in alignment with x-functional stakeholders
  • Leads priority projects in close collaboration with Medical Lead Operations, Governance and CES or Medical Head

Who You Are:

You are a strategic thinker who excels in driving operational excellence within Medical Affairs. Your ability to act as an SME for QMS and process ownership sets you apart and allows you to guide teams ensuring everything runs smoothly and efficiently. You seek out and implement improvements across functions, seamlessly collaborating with stakeholders at all levels. Your communication skills, your leadership and your spirit allow you to ensure our Medical Affairs division operates with precision and innovation.

Qualifications:

• Master in science, marketing, economics or equivalent
• 7+ years of relevant work experience including work in pharmaceutical industry
• Broad and approx. 7+ year long experience from biotech / pharma business
• Crossfunctional experience (across multiple cross functional disciplines (medical, sales, marketing or within a function)
• Leadership experience
• Externally focused roles or projects
• Experience from highly crowded, competitive markets with cost containment
• Experience from growth business; launching new products, starting new business

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.