Sr. Regulatory Project Manager

Senior Regulatory Project Manager

A diagnostics company in the Concord, CA arae is looking for a Senior Regulatory Project Manager to join their team. This is an 18 month contract position and we are looking to identify someone immediately. The Senior Regulatory Project Manager will be responsible for managing the team and activities focused on completion of a PMA submission.

Senior Regulatory Project Manager Responsibilities:

* Actively partners with Sr. Management and team to achieve project goals.
* 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 to achieve project objectives. Assists in securing the necessary resource support from departments and Sr. Management 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.
* Anticipates and manages variances with risks; proactively utilizes contingency planning.
* Prepares agendas, meeting minutes, and action items for project team meetings.
* 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.

Senior Regulatory Project Manager Qualifications:

* Bachelor of Science degree in a scientific discipline or equivalent with a minimum of 5 years experience in the management of multidisciplinary project teams.
* PMP certification preferred.
* Must have experience with project management of late-stage development projects, including support forINDor PMA regulatory submissions and approvals.
* Ideal candidate will have demonstrated ability to review and edit technical/clinical documents.
* 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 some travel to achieve project objectives.

If you are interested in applying for this role, please respond to this job posting ASAP to be considered.

To find out more about Real Staffing please visit www.realstaffing.com