Job Summary - a concise overview of the job
The Project Manager, Project Management is responsible for leading project teams and managing cross-functional activities for a portfolio of projects through regulatory submissions, product approval and launch. This role will primarily focus on New Product Launches (all sites) and R&D projects for Chestnut Ridge NY as well as 3rd party manufacturing facilities.
Projects include but are not limited to scale up, new product launches, site changes, external product integration and business development opportunities. Tracks and reports progress identifies risks, and provides expertise to resolve project difficulties to meet project deadlines required to ultimately deliver products to market. Works with sales and marketing to evaluate current market conditions to calculate launch requirements and communicates the requirements and timelines to operations and supply chain to ensure day 1 readiness for launch. Prepares trade dress and financial sign off and lead new product launch meeting.
Builds effective client and team relationships. Competence is demonstrated by managing the project plan, the assigned resources, reviewing financial forecasts and the project activities. This individual will serve as key contact person for internal and partnered project-related issues and is accountable for successful delivery of the project.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Oversees new product launches for all sites including Chestnut Ridge NY, Chennai India, Rochester, MI, Irvine, CA and 3rd party manufacturing facilities
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Ensure that key development milestones are achieved and that the project is progressed in a timely manner for successful product filing & launch.
Manage client relationship and ensure that good communications are maintained
Evaluate the probability and impact of risks and develops plans for minimizing their impact on the project.
Conduct team meetings/teleconferences, provide agendas, issue minutes with follow-up actions identified, and have the ability to be the lead contact and subject matter expert of delegated projects.
Maintain awareness of current market conditions and competitive products.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Must have Bachelor’s Degree with 2-4 years of relevant Project Management work experience, preferably in generic pharmaceuticals.
§ Experience with the R&D/formulation project life cycle and product launch process, Sales, Sales Operations, Finance or Marketing departments a plus.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Familiarity with generic pharmaceutical product development and regulatory process.
§ Microsoft Office Skills
§ Knowledge of Microsoft Project
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Must be proficient in communicating and interacting with all levels of management as well as outside organizations.
§ Strong planning & organizational skills and established writing skills required.
§ Demonstrated ability to lead project teams, cross-functionally multitask and be innovative.
§ Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
§ Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
§ Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
§ Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
§ Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
§ Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
§ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Office environment
§ Minimal overnight travel is required.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.