Associate Director Regulatory Project Management
Associate Director Regulatory Project Management
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Job Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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
As the Associate Director Project Management you will be assigned projects of increasing complexity. You will manage the full Project Management lifecycle for assigned projects and act as a functional area expert. Where applicable you will lead and/or support development and implementation of Project Lifecycle Plans. You will develop and manage project plans and manage project timelines communications meetings and other interactions to ensure project deliverables are met ontime and to the quality expected working with no supervision. You will represent the Project Team to various partners and stakeholders. You will typically manage multiple projects simultaneously. You will also contribute to short and longrange RPM strategies plans and infrastructure development. You will also lead RPM process improvement activities and lead complex Regulatory initiatives and/or complex Development initiatives.
Essential Duties and Job Functions:
- Directs moderately complex department/crossfunctional specific programs and/or initiatives.
- Directs 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 Regulatory Operations 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 subteam 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 NDAs MAAs BLAs sNDAs/T2Vs RTQs submissions across projects/programs (platform).
- In relation to Regulatory submissions tracks and prepares project information and activities including minutes timelines action items and functionspecific deliverables. Ensures integration of project timing scope and resources.
- 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 Project Sponsor/Regulatory Lead(s) to develop gain approval and execute on strategy.
- Chairs project meetings and coordinates moderately complex team operations and communications.
- Will initiate or contribute to local and global process improvements across therapeutic areas which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs functions at other global sites.
- Organizes and/or leads preparation of highquality 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.
- Works with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements other local or regional regulatory requirements as applicable and company policies and procedures.
Minimum Education & Experience:
- BA/ BS or MA/MS/MBA with relevant project management or scientific experience in the biopharma industry
- A scientific background may be required.
- Consolidated experience in leading crossfunctional project management activities within the biopharma industry; building managing and articulating comprehensive complex crossfunctional plans.
- Proven effectiveness managing project teams in life sciences including effectiveness in preparing compelling RFX documentation for senior leadership determining the appropriate scope of projects helping project teams develop creative alternative scenarios and acting effectively as a thought partner to others.
- Proven track record of successfully managing multiple projects simultaneously.
- Line management (direct reports) experience is a plus.
- PMP (Project Management Professional) or other PM certification or equivalent is a plus.
Knowledge & Other Requirements:
- Some management/ mentorship experience preferred.
- PMP or PRINCE2 desired.
- Recognized as a functional area expert for specific products programs projects and/or initiatives.
- Ideally have a modest knowledge of regulatory requirements specific to key regions such as the US and EU and have a general awareness of current global and regional trends in Regulatory Affairs.
- Strong negotiation and conflict resolution skills.
- Has complete knowledge of full cycle project management from project startup to closeout and has shown ability to effectively apply this knowledge to achieve targeted project outcomes.
- Has advanced knowledge of project management best practices and tools and has shown ability to apply these to improve project efficiencies and effectiveness.
- Has significant industry knowledge including knowledge of drug development and is able to flex own knowledge to work on molecule and/or nonmolecule projects.
- Has advanced knowledge of functional or therapeutic area as evidenced by independence in designing implementing and managing project team plans deliverables and resource management.
- Demonstrates expertise in developing and managing project scope deliverables risks and resource requirements.
- Knowledge of Agile Methodologies and their application in the R&D biopharma environment.
- High degree of organizational awareness and knowledge of change management with the ability to help teams anticipate plan and adapt to an evolving environment.
- Strong leadership presence with demonstrated ability to lead without authority and influence programs projects and/or initiatives.
- Ability to understand and communicate scientific and/or business elements in a clear and concise manner.
- Strong interpersonal skills and understanding of team dynamics.
- Proven ability to work successfully in a teamoriented highlymatrixed environment.
- Demonstrated ability to independently take on and execute multiple complex tasks.
- Ability to take accountability and empower individuals and teams to make effective decisions which are aligned with the companys vision values and goals.
- Must be quality driven individual with strong attention to detail and accuracy.
- Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment trust accountability expertise transparency and collaboration.
- Advanced knowledge and skill with Microsoft Project Microsoft Excel and other reporting and tracking tools.
- When needed ability to travel.
Gilead Core Values:
- Integrity (Doing Whats Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs companysponsored training education assistance social and recreational programs are administered on a nondiscriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Required Experience:
Director
Employment Type
Contract
