Filing Project Manager, Late Stage Program
Our client is looking for a highly qualified and skilled professional for the role of Filing Project Manager in Cambridge, MA. We are looking for a Filing Project Manage with 6+ years of project management experience in the biotechnology/pharmaceutical industry. This role will be Reporting to the VP of Regulatory Affairs, and will work closely with the Regulatory Lead and the Program Team to enable successful planning and execution of Marketing Authorization Submission.
- R & D focused project/program management for a late stage program
- Maintain real-time Microsoft project and overall program timelines and deliverables through NDA/MAA submission and registration
- Help with maintenance of plans, identify interdependencies
- Alert team members on deadlines and deliverables and follow through
- Facilitate management of risk register in real time
- Maintain project dashboard for sharing progress and risks with senior management
- Serve as center of program team matrix - attend program team and sub-team meetings – help manage and follow through on project deliverables and outstanding action items between nonclinical, CMC, clinical and regulatory sub-teams
- Help with drafting meeting agendas and minutes
- Interface with filing team and alliance partner actively to problem solve and enable decision making/follow through
- 6+ years of project management experience in the biotechnology/pharmaceutical industry
- Intimate knowledge of entire life cycle of drug development
- Submissions experience
- NDA/MAA filing experience a plus
- Strong PM exp in R&D
- Associate Director to Director level skill set
- Must have filing experience
- Very good communication and inter-personal skills
- Ability to interface with all levels across the organization and with alliance partner
- Ability to work in a fast paced environment and driven to succeed
- Ability to problem solve, identify bottlenecks, and escalate issues appropriately in a timely fashion
- Bachelor's Degree
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
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