The Project Manager leads a set of interrelated projects and/or programs from initiation to close, to deliver effective solutions that meet business needs. The role is accountable for determining and delivering solutions to approved budget and schedule commitments while meeting required quality and compliance standards. Focus areas include stakeholder management (varies by stakeholder), risk management and delivery of business benefit. This role is also required to follow established project management standards and lead/contribute to continued development of the project/program management capability.
Summary of Essential Job Functions
Plays a key role in the creation and optimization of the Project Charter, Project Scope
Statement, Project Plan, Project Closing Documents, and other project related documentation.
Drives the development and operational delivery of the project plan in accordance with Project Management best practices, Healthpoint Biotherapeutics Standard Operating Procedures and Guidance Documents, and the product profile.
Works with the Clinical Study Manager, Marketing Portfolio Manager, Research & Development, and other stakeholders to create a project budget.
Establishes and leads one or more project teams, ensuring technical alignment with the commercial and marketing strategy for the project and managing the project and project team to key milestones and targets.
Works to build and maintain the effectiveness of the project team, including regular checks on team health and identification and resolution of team performance issues.
Manages risk, variance, and change control for the project and reports to executive management as appropriate.
Ensures effective standards of communication across functional areas within the project and Company by using appropriate blend of meetings, networking, E-communication and formal reports.
Bachelors Degree in the Sciences, with a minimum of 5 years documented experience in project management and pharmaceutical product development
Or, a Masters Degree with 3 years related experience and/or training.
Documented experience in program management is also required.
PMP Certification strongly preferred
Regulatory submissions in support of INDs, BLAs, NDAs, MAAs
Strategic planning, risk management, change management
Project financial planning
Ability to execute and deliver on tight timelines
Ability to estimate and track project financials
Ability to develop stage-gate project plans
Excellent interpersonal skills and ability to function in a team environment
Strong verbal and written communication skills
Demonstrated ability to work well with others within and across functions/teams
Effectively utilizes information technology systems and project management tools
Capable of managing meetings within a multicultural environment
Ability to adapt behavior to situation
Ability to follow-up with tenacity
Ability to hold oneself and others accountable for commitments in a productive and assertive, positive(not aggressive) manner
Good analytical and planning skills
Strong communication skills both written and verbal
Skilled in writing project documentation
Ability to communicate well one-on-one and in small groups
Excellent interpersonal skills
Able to foster open communication
Healthpoint Biotherapeutics is committed to conducting business in an ethical manner and it is our expectation that the individual in this role will ensure compliance with all applicable laws, regulations, procedures and Healthpoint’s Core Values. Healthpoint is in a highly regulated industry and, as a part of this role, this individual will be required to understand how compliance is integrated within their daily activities and perform in their role with a high level of integrity.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Healthpoint Biotherapeutics, a Smith and Nephew Business, is an Equal Opportunity Employer.