Regulatory Project Manager - III

Job Title : Regulatory Project Management (RPM)

Location : Foster City, CA preferred but open to remote candidates

Duration : Long Term

POSITION OVERVIEW :

With increasing independence, you will support other Development team members with project and / or process administrative tasks of low complexity. Your responsibilities include, but are not limited to, supporting project communications, conducting follow-up with project team members, partners or stakeholders, tracking project information, helping maintain project timelines, and performing other administrative work to support RPM colleagues and project team members. With close supervision and guidance, you may also manage sub-projects.

EXAMPLE RESPONSIBILITIES :

• Manages basic department / cross-functional specific programs and / or initiatives.
• Manages basic project / initiative communications and works in partnership with senior-level Project Management to ensure that all stakeholders are fully informed and knowledgeable of project activities and their status.
• Provides Regulatory Project Management support for assigned programs / projects / initiatives; may attend sub-team meetings.
• Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate.
• Identifies and manages critical path activities.
• Supports 1 – 2 Regulatory Projects, including but not limited to cross-reference INDs, original INDs, and simpler RTQs.
• In relation to regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.
• Works in partnership with senior-level Project Management and / or Project Lead to ensure timely, efficient and effective meetings and progress on activities between meetings.
• Works in partnership with senior Project Manager and / or Project Lead to execute on deliverables.
• May coordinates basic team operations and communications.
• Works with senior Project Management to generate periodic project team and sub-team updates and assists with preparation of formal presentations as required.
• May implement routine process improvement and optimization initiatives as required.
• May manage sub-projects as assigned.
• Focuses on operational tasks, learns how to manage submissions independently, and starts to develop a strategic mindset.
• Ensures project work complies with established practices, policies and processes and any regulatory or other requirements.

REQUIREMENTS :

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

Knowledge & Other Requirements

The salary range provided for this contract role represents our good faith estimate for this posi tion. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.