Associate/Director, Regulatory Project Lead, Regulatory Affairs

18 Apr, 2021

Jobs

Associate/Director, Regulatory Project Lead, Regulatory Affairs

Moderna
Cambridge, MA

The Role:

As the Associate Director/Director, Regulatory Project Lead, you will work in close collaboration with Regulatory Strategy and Operational teams, as well as cross-functional teams across the organization (i.e., Clinical, Nonclinical, and Quality) to identify submission risks and opportunities, define regulatory deliverables, and build and manage timelines to support regulatory filings through licensure and beyond.

Here’s What You’ll Do:

  • Define, manage, and track specific deliverables needed for regulatory submissions working with cross-functional teams, including INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests, etc.

  • Develop detailed project timeline views that identify key milestones to meet business objectives (e.g. from clinical trial initiation to regulatory submission and approval)

  • Track and monitor timelines for key activities (e.g. database lock, document deliverables, authoring responses to health authority questions and meeting regulatory commitments).

  • Ensure roles and responsibilities for project team members are clearly documented via RACI’s and/or swim lanes in process flow diagrams.

  • Lead and manage cross functional meetings to drive decision making and project execution.

  • Ensure creation of agendas, meeting minutes, and tracking/resolution of action items.

  • Proactively provide status updates to designated stakeholders via dashboards and milestone reports, and ensure leadership is aware of critical considerations.

  • Ensure that overall regulatory project timelines are aligned cross-functionally and support the coordination of timely regulatory submissions.

  • Identify and recommend solutions for timeline concerns or obstacles, including risks and issues; engaging appropriate leads for mitigation and resolution, ensuring that all issues arrive at a conclusion or recommendation.

  • May assist in management of special projects as needed, e.g. oversight of system/process improvement projects.

Here’s What You’ll Bring to the Table:

  • BS degree in a scientific field with 10 years of experience or MS degree in a scientific field with 6-8 years of experience in a biotechnology or pharmaceutical setting

  • Must have experience in late stage drug development and/or submission experience

  • Preferred experience with vaccine development, ideally from discovery through licensure

  • Proven track record of successful project management experience supporting early- and late-stage and submission programs

  • Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility

  • Strong knowledge of project management tools and software and ability to learn new tools

  • Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally

  • Strong personal and leadership skills to influence without authority, motivate others and manage conflict

  • Strong written and oral communication skills as well as demonstrated organizational aptitude

  • Strong working knowledge of MS Project, Smartsheet and timeline visualization software (i.e. One Pager, ThinkCell)

  • Preferred: Project/program management training

Here’s What We’ll Bring to the Table:

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.  Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.  Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Learn more here

Job posted: 2021-04-18