【Alexion Japan】Senior Manager, Project Management

This is what you will do:

The Senior Manager, Project Management is accountable for the generation and maintenance of program timeline for Japan local portion including Advisory Board meeting, internal governance endorsements, PMDA consultation, J-CTN, clinical studies, regulatory submission, launch planning levels in alignment with Japan program team (JPT) and global program team (GPT). This role is a key contributor to facilitate JPT meeting through keen collaboration with Japan program team lead (JPTL). It is also expected to support strategy alignment between JPT and GPT, obtaining internal governance endorsement, etc. based on good relationship and communication with global project manager (GPM).

You will be responsible for:

•            Work closely with JPTL to support project delivery and goal achievement.

•            Generate and maintain program timelines (base, stretch, etc.).

•            Facilitate the program meetings related to development such as JPT meeting, JPT sub-team meeting, etc. and support owner of the meeting. (agenda creation, hosting, minutes taking, etc.).

•            Manage progress of action items to move forward the program efficiently.

•            Manage risk/mitigation plan and issue/contingency plan and actions.

•            Support the internal governance endorsements by developing and maintaining program timeline visual depictions.

•            Ensure that timeline conform to global standards and key milestones are coded correctly.

•            Partner with JPTL to ensure that the program information is accurate and up-to-date in planning systems and reporting.

You will need to have:

•            At least 5 years of experience in pharmaceutical R&D drug development

•            At least 3 years of previous project planning or related experience.

•            Solid understanding of drug development, resource management and associated business processes.

•            Technical proficiency includes demonstrated proficiency in the use of project planning and resource forecasting tools and systems (e.g. Microsoft Project , resource forecasting, decision analytics, simulation), and the use of reporting tools (e.g. Business Objects, Spotfire)

•            Well-developed expertise in scheduling and resource forecasting tool(s), definitions and standards, and associated systems and tools.

•            Proven track record of planning and managing complex projects

•            Knowledge of the drug development process, biologics pathway and delivery paradigm

•            Strong written and verbal communication skill

•            Strong organizational skills and the ability to multitask; can set priorities and follow a timeline

•            Must be a self-starter, collaborates cross-functionally, and capable of working independently

•            Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.

•            Has experience to lead cross functional meeting related to clinical study.

•            Has a firm understanding of how to educate/advise/operate with respect to Regulatory Guidances/Internal SOPs/Project best-practice behaviors.

Date Posted

10-5月-2024

Closing Date

30-12月-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.