Project Manager, RACMC NJ
3 weeks ago
Join a Legacy of Innovation 125 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This role involves efficient resource management, and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high-quality deliverables, and implements process improvements. Resource management is crucial, along with fostering a collaborative team environment. Ultimately, this role ensures RACMC filings are submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and regulatory compliance.
Responsibilities
Coordinate global regulatory dossier generation and submission activities as a project manager. Support global project and submission teams with project management expertise. Create and maintain regulatory project and submission plans, schedules, and resources. Identify and manage regulatory submission risks and issues. Conduct regular project meetings and provide updates to stakeholders. Collaborate with internal stakeholders to successfully implement regulatory projects, submissions until approval. Monitor submission progress and report project team and submission status to Global RACMC management. Develop and implement process improvements to enhance project efficiency. Oversee, manage and maintain IT tools, processes and knowledge management sites. Participate assigned non-project tasks and process improvements. Provide technical guidance and support to team members in processes and IT tools.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Bachelor's Degree Bachelor or Master's degree in Life Science or Pharmacy required
Master's Degree preferred
Experience Qualifications
4 or More Years Minimum of 5 years of experience in the pharmaceutical industry required
4 or More Years Minimum of 3 years of experience in regulatory affairs required
Project Management knowledge and certification preferred
Proven ability to plan, coordinate and lead projects simultaneously on multiple projects preferred
Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organization preferred
Experience of working in global environment in interdisciplinary teams preferred
Experience of working in interdisciplinary teams preferred
Knowledge of project management tools and processes preferred
Ability to travel up to 10% International travel may be required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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