Support and manage daily development, commercial and project management activities in support of the company’s products.
Summary and Scope of Position:
Support and manage daily development, commercial and project management activities in support of the company’s innovative biological products.
- Actively partners with the Project Leader or Product Manager to manage Core teams or sub-teams, as needed.
- Defines, implements and supports the team structure and operating guidelines.
- Accountable for producing, maintaining, and monitoring project plans, budgets, and timelines.
- Identifies and estimates resource requirements in collaboration with department heads to achieve project objectives. Assists in securing the necessary resource support from department and/or project leads and communicates gaps or conflicts which may impact project scope, schedule, or budget.
- Manages the team to deliver major project/corporate milestones and set clear and realistic goals consistent with business needs.
- Establishes, tracks, and communicates project deliverables using appropriate tools.
- Provides constructive feedback on team member performance and facilitates conflict resolution.
- Works with teams to identify project risks, anticipates and manages variances with risks; proactively utilizes contingency planning.
- Prepares agendas, meeting minutes, and action items for project team meetings. Follows up on action items to achieve timely closeout.
- Effectively facilitates project team meetings and other key project-related meetings.
- Clearly communicates outcomes from team meetings and key project meetings to team and senior management (may include internal and/or external presentations).
- Provides project oversight to senior management via monthly reports, timelines and other reporting mechanisms.
- Bachelor of Science degree in an applicable scientific, health science, or engineering discipline with a minimum of 7 years' experience.
- Excellent analytical skills and the ability to apply GCP, GMP, ICH and Design Control policies and regulations (e.g. ISO 13485, 21CFR 820,30, ISO 14972, USP 800) to specific products or projects.
- Experience in manufacturing, clinical trial, or regulatory submission experience in the pharmaceutical, biotech, or medical device industry.
- Progressive experience managing multidisciplinary scientific project teams.
- PMP certification preferred.
- Strong leadership management and mentoring skills; team oriented.
- Flexibility and ability to multi-task; ability to adapt to changing priorities.
- Excellent communication skills (encompasses verbal, written, interpersonal, listening).
- Proven time management skills (timelines, schedules, task prioritization).
- Previous budgeting experience required.
- Proficient in the use of all Microsoft Office products and MS Project.
The position may include domestic and international travel as needed to achieve project objectives.
To confidentially investigate this and other opportunities, please contact Eric Wheel, Partner, 415-318-8700 x101, email@example.comHelp.