Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 48,000 employees worldwide and around 3,000 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 Manager Project Management and Delivery Solution clinical & Submission Support - Pharmaceutical Development Combination Products (all genders) (full-time, permanent)

Primary responsibilities and influence on AbbVie

AbbVie is looking for a project manager who 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. This individual will also lead the efforts in supporting clinical trial readiness for the development of new drug delivery systems.

In this role you are accountable for leading cross functional teams (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, Project Management, and External Partners) in the execution 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). In addition, product development timing and scope needed to support plans for CMC gate reviews and each clinical phase. Also, as clinical trial support, the project manager will support activities related to clinical study preparation, clinical supply readiness, and regulatory submissions with respect to drug delivery systems. You will be accountable for working cross-functionally across the clinical development, operations, and supply organizations for readiness for clinical trials.

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 forward-looking evaluation of potential partners
• Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
• 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 processes and tools
• Clinical trial support: execute activities related to clinical study preparation and execution including support to complaint handling

Qualifications

Qualifications

• Bachelor’s degree in sciences like pharmacy or engineering or related scientific field with 12 years of experience OR Masters + 10 years’ experience OR PhD + 4 years’ experience
• Theoretical and practical experience in the combination product, medical device and/or pharmaceutical industry
• Leadership of technical professionals; proven effective leader to cross-functional teams with focus on build and qualification of delivery systems
• Skilled in the initiation, selection, coordination, and management of projects and can solve unique problems.
• Requires an 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 execution of incoming reportable device combination product events to comply with global regulations.
• Up to 25% travel may be required to effectively manage communication between multiple Abbvie sites and third-party suppliers. Fluency in English and German is preferred.

Here's 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 work-life 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 top-tier, 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 work-life 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html