DESCRIPTION:

The Project Manager is a key role in the project & portfolio management organization responsible for promoting and developing initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives with regards to FDA submissions. Acts as an advisor to subordinates.

EDUCATION:

• Bachelors Degree (BA/BS) Bachelors Degree (BA/BS) Pharmaceutical Sciences, Engineering or related field - Required
• Master Degree (MS/MA) Master Degree (MBA) Pharmaceutical Sciences, Engineering or related field - Preferred

EXPERIENCE:

• 2+ years of experience in generic pharmaceutical development process in one of the following: drug formulation / analytical development, clinical strategy development, or project management.
• 5 years of experience in Product development

SKILLS:

• Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. - Intermediate - Intermediate
• Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. - Advanced - Advanced
• Excellent written and verbal communication skills and interpersonal skills. - Advanced - Advanced
• Ability to communicate effectively and collaboratively as part of a team in a respectful manner. - Advanced - Advanced
• Ability to work independently, self-starter. - Intermediate - Intermediate
• Good problem solving skills and analytical ability. - Intermediate - Intermediate

• Leads and manages all activities related to product development through the entire product cycle from strategic and tactical perspectives. Has the ability to define clear project scopes, goals and deliverables that support business objectives.
• Possesses an understanding of the technical details underlying product development to effectively strategize, plan and co-ordinate project activities with the functional stakeholders and senior management. Needs to have the ability to provide an independent opinion on all project activities and to be counted as part of the decision-making group.
• Leads and develops an independent function to effectively communicate project expectations and timelines, proactively anticipate project related issues and devise contingency plans.
• Develops and implements an efficient process for managing all aspects of product development to include managing weekly R&D meetings, maintains accurate timelines of internal and external events related to the projects, and provides weekly/monthly update documents, proposals and presentations.
• Participates and provides input into developing and maintaining ongoing project expenses and annual budgets.
• Builds strong relationships with cross-functional and multi-disciplinary stakeholders to drive various project requirements in an efficient manner. Must have the capability to build strong team dynamics of diverse individuals representing the various functions as part of product development.
• Must have the ability to work with external vendors such as CROs, CMOs, consultants, material vendors and other external third parties to drive a strong development program.