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Sr Regulatory Project Manager

Company: Yoh
Location: Cambridge
Posted on: March 30, 2024

Job Description:

Sr Regulatory Project Manager Alnylam Pharma ID # 31897077 Cambridge, MA- Hybrid 8 month W2 contract (with potential to extend or transition to perm) Pay rate: $85-87/hour - Depending on Education and Experience Summary: Hybrid - 2 days onsite each week Reports to the Director of Global Filing Excellence and Project Management -

  • Given Alnylams uniquely robust late stage pipeline, a need has been identified to establish a focused capability to develop and implement best practices for preparing major global regulatory filings.
  • This role will work closely with the Global Regulatory Lead and Regulatory Operations, as well as cross-functional filing teams and management to facilitate timely submission of high-quality data packages to US and international health authorities. Responsibilities:
    • R & D focused project management for late stage global regulatory filings Develop and optimize detailed regulatory project plans and timelines in close collaboration with Global Regulatory Lead, Regulatory Operations Lead and filing sub-team leads
    • Maintain real-time filing timelines and track deliverables through NDA/MAA submission and registration
    • Interface with filing subteams to ensure that timelines and deliverables for NDA/MAA filings are mutually understood and agreed
    • Facilitate and co-lead critical filing 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
    • Maintain project dashboard for sharing progress and risks with senior management; identify and escalate risks related to resources and timing as appropriate Identify and highlight project interdependencies
    • Develop document reviewer matrix and coordinate reviews and roundtables as needed per the filing timelines
    • Plan and facilitate cross functional workshops focused on execution of submission strategy
    • Coordinate lessons learned sessions and ensure implementation of feedback for process improvement
    • Contribute to development of best practices and standardized process for filing of NDA/MAAsSkills or Requirements:
      • Demonstrated project management skills with demonstrated ability to prioritize multiple projects.
      • Experience developing project plans, content plans and other filing tools.
      • Strong technical system proficiencies particularly Smartsheet, MS Project, Visio and Excel, Veeva, SharePoint (Think-Cell, Milestones Professional, OnePager, or similar a plus)
      • Excellent organizational and meeting management/facilitation skills Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels
      • Excellent written and verbal communication skills, including negotiation skills.
      • 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
      • Working understanding of regulations and experience in interpretation of Health Authority guidelines.
      • Experience with regulatory filings, original NDA/BLA/MAA and response to questions a plus
      • Clear alignment with Alnylam Core Values including: Commitment to People Innovation and Discovery Sense of Urgency Open Culture Passion for ExcellenceEducation/Experience:
        • Bachelor's degree in scientific or medical field preferred
        • Minimum 6 years experience in biotechnology or pharmaceutical industry What's In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.
          • Medical, Dental & Vision Benefits
          • 401K Retirement Saving Plan
          • Life & Disability Insurance
          • Direct Deposit & weekly ePayroll
          • Employee Discount Programs
          • Referral Bonus ProgramsNote: Any pay ranges displayed are estimations. - Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. - All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit -to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, Cambridge , Sr Regulatory Project Manager, Executive , Cambridge, Massachusetts

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