Sr Manager, Project Management

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Position Overview:

You will act as the Project Manager for assigned projects. You will develop and manage project plans and manage project timelines, communications, meetings, and other interactions to ensure project deliverables are met on-time, and to the quality expected, working under minimal and at times no supervision. You will represent the Project Team to various partners and stakeholders. As assigned, you will also develop and lead continuous improvement and optimization initiatives. You will typically manage multiple projects simultaneously. As assigned, you will also lead RPM process improvement activities and/or lead complex Regulatory initiatives.

Responsibilities:

• Leads and manages moderately complex department/cross-functional specific programs and/or initiatives.
• Leads and manages moderately complex project/initiative communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status.
• Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.
• Provides Regulatory Project Management support for programs/projects/initiatives; attends sub-team meetings; organizes ad hoc working groups as needed.
• Provides leadership to the team and functional areas to anticipate and identify complex project issues which pose a challenge to achieving strategic goals; proposes and implements plans to resolve such issues and execute corrective actions.
• Identifies and manages critical path activities and resources.
• Manages 3 – 6 Regulatory Projects, included but not limited to INDs, NDAs, MAAs, BLAs, sNDAs/T2Vs, 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.
• May manage the work of less experienced colleagues, contractors, vendors and/or third parties.
• Works in partnership with Project Sponsor/Regulatory Lead(s) and stakeholders to ensure timely, efficient and effective meetings and progress on activities between meetings.
• Works in partnership with Sponsor/Regulatory Lead(s) to develop, gain approval and execute on strategy.
• Co-chairs project meetings and coordinates moderately complex team operations and communications.
• Organizes and/or leads preparation of high-quality documents for review by internal committees and external stakeholders. May author documents and/or procedures for leadership teams.
• Recognized as a functional area expert for specific project and/or programs.
• Has increased development of strategic and enterprise mindset.
• May represent Gilead at external professional meetings or discussions with industry trade groups.
• May develop and implement continuous improvement and optimization initiatives across the department.
• Ensures project work complies with established practices, policies, and processes and any regulatory or other requirements.
• Manages a low level complexity Project Teams.

Basic Qualifications:

• Doctorate and 2+ years of relevant experience OR
• Master’s and 6+ years of relevant experience OR
• Bachelor’s and 8+ years of relevant experience OR

Preferred Qualifications: