Senior Scientist I Project Manager Pharmaceutical Development Combination Products all genders full-time permanent

The job that makes possibilities real in patients lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48000 employees worldwide and around 3000 employees in Germany you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care Do you want to contribute to improving patients quality of life through your expertise In a challenging work environment that offers opportunities of developing and increasing your own skills Youve come to the right place!

Moving mountains together as Senior Scientist I / Project Manager Pharmaceutical Development Combination Products (all genders) (fulltime permanent)

The Project Manager is accountable for leading the cross functional team (Engineering Quality Supply Chain Marketing Operations Human Factors Project Management and External Partners) in the of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices Primary Packaging Accessories Secondary Packaging Instructions for Use and Labeling).  The Project Manager ensures that the strategy and plans defined for assigned projects are aligned with the needs of the patient and customer and the business objectives of the CMC and Asset team.  In addition product development timing and scope need to support plans for CMC gate reviews and each clinical phase. 

Summary of Responsibilities and Accountabilities:

The Project Manager will be accountable to the CMC team the CMC Product Development Director and delivery system Senior Leadership for delivering on the strategy plans and budget defined for the project portfolio.  

Responsibilities include:

• Leadership of a portfolio of drug delivery system product development projects
• Tactical and strategic management of external device partners including acting as a key interface managing the project governance process and forwardlooking evaluation of potential partners
• Device financial management including budgeting forecasting and longrange planning of delivery development expenses
• Representing the R&D organization to cross functional leadership through effective and timely communication
• Ensuring effective use of meetings by clearly defining objectives agendas inviting the team members specifically needed and publishing minutes and actions
• Driving continuous improvement on Project/project management processes and tools
• Direct management of project managers with responsibility for device/device constituent development projects 

Management of External Partners: The Project Manager leads the team in managing the relationship and performance of key external device development partners.   An effective and efficient development partner governance process should be defined and implemented including key interface definition meeting cadence schedule performance monitoring project scope/change control issue escalation and financial tracking.   Project risks must be identified and mitigated with the partner throughout the project lifecycle.  The Project Manager will ensure timely and efficient communication regarding partner performance will be provided to the broader AbbVie organization as required.   The Project Manager will work with the AbbVie contracts team and the partner to define and track performance to the Statement of Work.  The Project Manager will provide accurate and timely cost estimates for budgeting and forecasting. 

Impact on AbbVie: The role of Project Manager has broad influence and impact on the development and launch of AbbVies assets when a device/combination product delivery system is required.  These device systems are often technically complex involve multiple subsystems interface directly with the patient and must meet global requirements.  Typically external partner management is required.  The Project Manager must represent the R&D function to cross functional leadership through effective communication and use of influence skills   

Qualifications :

Qualifications

• Bachelors Degree or equivalent education and typically 10 years of experience Masters Degree or equivalent education and typically 8 years of experience PhD and no (some) experience necessary.
• Certification: Project Management Professional (PMP) Certification preferred but not required
• Deep theoretical and practical experience in the combination product medical device and/or pharmaceutical industry
• Leadership of technical professionals; proven effective leader to crossfunctional teams with focus on commercialization equipment selection build and qualification of delivery systems
• Skilled in the initiation selection coordination and management of projects and can solve unique problems.
• Requires an indepth understanding of the pharmaceutical product development cycle.
• Design history file project management and product development experience are essential.
• Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.
• Ensure timely of incoming reportable device combination product events to comply with global regulations.
• Must have working understanding and application of GMP principles concepts practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States Europe Asia Latin America).
• Up to 25 travel may be required to effectively manage communication between multiple Abbvie sites and thirdparty suppliers. Fluency in English and German is preferred.

Heres how we can move mountains together

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy worklife balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with toptier attractive development opportunities
• with a strong international network

Multiple times we have been globally recognized as a Great Place to Work and we are proud to provide our employees with the flexibility to maintain a healthy worklife balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality equity diversity and inclusion (EED&I) a commitment that is fundamental to us. This includes appreciating different perspectives creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie your individual contributions count help us move mountains together. Be a part of our success grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you We look forward to receiving your application! All you need is a complete CV we will discuss everything else with you in person.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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