Description:
Primary Function of Position:
The Project Manager creates and manages project schedules to support the development of internal Quality Management System (QMS) documentation for a medical device company.
Roles & Responsibilities:
- Work with technical writers, Subject Matter Experts (SMEs), and core teams to outline the scope of the documentation and Identify all affected documentation to be created or updated.
- Create schedules for documentation deliverables.
- Work cross-functionally with SMEs, and core teams to create strategy and timeline to support business needs.
- Identify, communicate, and help resolve risks, resource overloads, and content creation or revision constraints.
- Represent technical publications function on core teams.
- Coordinate with technical publications management on resource needs and project timelines.
- Establish deadlines and support needs with external translation vendors.
- Understand Regulatory Standards, Document Control, and Quality Assurance requirements for process documentation.
- Ensure Good Documentation Practices (GDP) are followed per relevant procedures.
- Participate in and initiate department process improvement projects.
- Flexible to support various other duties and assignments as requested to assist the overall function of the department.
Skills, Experience, Education, & Training:
- 3-8 years of project management preferred
- Bachelor’s degree in related field or equivalent work experience preferred
- PMP certification preferred
- Strong communication and presentation skills required
- Strong interpersonal skills and ability to interact with core team leaders and other functions required
- Strong organizational skills and ability to manage deliverables for multiple projects under tight deadlines, set priorities, and manage time effectively
- Creation of project schedules required
- Experience in a regulated environment required
- Experience with medical devices in an FDA and internationally regulated environment preferred
- Extensive knowledge of project management processes, organizational change management concepts, and business process improvement and documentation methods required
- Ability to multi-task and work both in a team and independently required
- Experience with change management software (Agile or equivalent) highly preferred
- Highly organized with good analytical skills preferred
- Understanding of localization process preferred
