At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Medical Project Manager (all genders) 

As Medical Project Manager, you act as an owner of medical data generation projects, contributing to Bayer’s purpose “Science for a Better Life”. You combine scientific excellence, operational rigor, and innovative ways of working, while leading projects in line with Bayer’s standard operating procedures (SOPs), all relevant legislation and guidelines including EU Directives, Country’s Medicines Law, Code of Practice (CoP) and all relevant regulatory guidelines.

YOUR TASKS AND RESPONSIBILITIES

• Management of global and governance and management of local:
  • non interventional studies (NIS) / Observational Studies (OS) incl. post authorization and risk management studies required by authorities
  • investigator initiated research (IIR) projects
  • institution sponsored collaborative studies (ISCS)
  • novel study designs, e.g., digital device settings
• Responsible for set up of new NIS & IIR & ISCS
• Give guidance on feasibility, study concept, and study operations
• Building and leading OS core teams for local NIS
• Coordinate cooperation of local and international as well as internal and external (e.g., CRO) partners for the whole project
• Responsible for adherence to internal (e.g., SOP) and external approval processes and legal requirements including relevant codices
• Management of the production of all study documents and systems
• Planning and controlling of project budgets
• Training of involved parties (e.g., internal staff, physicians, MSLs, Sales Force, CRO)
• Management of analysis, documentation, archiving, and communication of study results
• Adherence to international regulatory requirements and standards (IFPMA, EFPIA, FDA, VFA, FSA, BfArM) incl. trial posting
• Flexible Project Assignments within Digital Innovation. The scope of these initiatives is dynamic and adapts to strategic priorities and organizational needs

Key Interfaces

• Internal: local and global Therapeutic Areas, Business Units (Lead, Marketing, Sales Force; MSLs, Controlling, Pharmacovigilance, Legal, Global IEG, PS; Purchasing department)
• External: Physicians, CRO, Ethic Committees, national study boards, thought leader, service provider, competent authorities

WHO YOU ARE

• Life Science degree (PhD preferred), several years of professional experience and proven track record in pharmaceutical industry and study management
• Experience in planning and managing observational studies and/or investigator-initiated studies
• Excellent interpersonal skills
• Ability to read and interpret clinical study data
• High level of organization, achievement oriented, reliable, able to cope with high workload
• Decision making and problem-solving skills, and ability to interface at senior level with third parties
• Good understanding of company organization, excellent knowledge of relevant software and databases
• Knowledge of relevant legal standards and codices
• Excellent communication skills in German and English

WHAT WE OFFER

Our benefits package is flexible, appreciative, and tailored to your lifestyle, because: What matters to you, matters to us! 

• We ensure your financial stability with a competitive salary between 88.900€ and 108.000€ per year (full-time) plus a variable component. Your compensation is based on your qualifications, skills, and professional experience.  
• Whether it’s hybrid work models or part-time arrangements: Whenever it is possible, you will have the flexibility to work how, when and where it is best for you.
• Your family is a top priority. We offer loving company daycare centers at multiple locations, support in finding childcare, time off for the care of elderly or dependent family members, summer camps for children, and much more.
• We support your professional growth by providing access to learning and development opportunities, training programs through the Bayer Learning Academy, development dialogues, as well as coaching and mentoring programs.
• We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.

Be You. Be Bayer.

The role is to be filled by Bayer Vital.

#LI-AMSEMEA  

Location:

Germany : North Rhine Westfalia : Leverkusen  

Division:

Pharmaceuticals 

Reference Code:

871304