This position can be located either in our Princeton, NJ or Rockville, MD office.
Program Manager acts as a central contact for information on a particular program and manages activities to develop and commercialize programs. Ensures that team and line management concurrence is reached on program objectives and meets the planned objectives to achieve the organization's goals of timely and quality-focused development of new therapies and life-cycle extensions within the portfolio. Works with senior project management staff and teams to create the development strategy, establish objectives, and monitor team progress. Makes recommendations regarding project objectives, resource requirements, and scientific direction to line and senior management.
- Under the direction of manager, responsible for supporting departmental and corporate initiatives to drive process improvements.
- Provides professional program management for 2 or more complex development programs.
- Facilitates the review of development projects with Senior Management, makes recommendations for action and ensures appropriate follow-up by management to achieve approved program/project objectives.
- Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions such that it will foster positive interactions and ultimately support achieving desired project outcomes.
- If applicable, functions as an development alliance liaison helping to support development alliance management activities based on program requirements.
- Responsible for ensuring smooth transitions between action points from initiating IND through product launch and full life cycle management, from early to late stage development.
- Supports quarterly forecasts, manages scope, timeline and financial changes through tracking variances at the program level.
- Responsible for maintenance of the project actions, decisions and issues (ADI) log for project team interactions.
- Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals.
- Works with the Product Development Committee (PDC) and relevant functional areas to lead the development of quality strategic development & commercialization plans which integrate the development strategy and project plan (inclusive of timelines, milestones, interdependencies, issues, risks and actions).
- Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional issues, scope issues at project and program level, timeline issues, and budget issues. Works proactively with manager and the project team to achieve timely resolution of these issues in order to achieve approved program objectives. These activities include those that are outsourced.
- Responsible for ensuring timely, accurate and comprehensive project and program information is available to senior management and the wider global organization.
- Notifies and escalates issues, risks and outcomes to senior management and governance bodies.
Travel is approximately 20%
- Understanding of the clinical, regulatory, and commercial requirements for early and late stage drug development
- Knowledge of clinical operations and the regulatory process
- Knowledge of global drug development, registration, and market launch requirements
- Thorough understanding of each functional area's role and contribution to the development process
- Ability to develop and implement cross-functional global drug development plans (GDDP), including strategic assessment of budgets and timelines
- Strong analytical skills
- Solid computer skills with MS Project, Word, Excel, PowerPoint, and Outlook
- Excellent interpersonal, communication and negotiation skills
- Bachelor's degree + 5 years of project or program management experience in the pharmaceutical industry
- MBA + 3 years of global drug development experience
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion ( 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.