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Associate Director: Regulatory & Medical Affairs (50% Remote)

  • Location: Lawrenceville
  • Job Type:Contract

Posted 18 days ago

  • Expiry Date: 29 May 2022

Job Description:

MUST HAVES:

  • Solid scientific background, Ph.D., M.D., PharmD, MS, or BS.

  • 5+ years of experience in Regulatory Affairs- Precision Medicine or Digital Health.

  • Proven track record in supporting at minimum of 3 prior Precision Medicine or Digital Health projects.

Responsibilities:

  • Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital

  • health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.

  • Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.

  • Ensure global regulatory plans support a precision medicine approach e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.

  • Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists and collaborates in strategic meetings with health authorities.

  • Represents key interactions with Health Authorities

  • Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug, diagnostic, and digital health products.

  • Ensure high quality collaboration with Precision Medicine/Digital Health teams to development of companion diagnostic, digital health tools and other device to optimize access to patients.

  • Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.

  • Provides guidance on planning, writing, review of key dossier documents for submissions globally.

  • Ensure Global Regulatory Science and Policy representation as needed in governance or strategic teams or committees.

  • To ensure compliance of programs with regulatory requirements for diagnostics and devices.

  • Provides ongoing feedback and accountable for coaching, and career development to staff in order to maximize their potential.

Required:

  • Solid scientific background, Ph.D., M.D., PharmD, MS, or BS

  • Significant experience in regulation of diagnostic/digital health devices (e.g. > 5 years)

  • Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of device clinical trial application submissions and approvals in US and EU/UK

  • Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for diagnostic/digital health tool development and approval with particular focus on US and EU/UK

  • Experience of drug development and drug regulatory procedures.

  • Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the drug and device development and commercialization process.

  • Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.

  • Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.

  • Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management.

  • Direct experience in developing strategy and leading teams through interactions with health authorities.

  • Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.

  • Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.

  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.

  • Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.

  • Experience as a member of global regulatory subteam, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).

  • Experience utilizing leadership techniques to drive a team through the stages of team development.

  • Proven ability to coach and mentor other leaders as a coach, while being an individual contributor to projects.

  • Successful track record of leading through influence and working across complex, global organizational matrices.

Other Qualifications:

  • Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.

  • Communicates opinions, facts and thoughts with clarity, transparency and honesty.

  • Sets clear and high expectations and holds self and others accountable for decisions and results achieved.

  • Seeks multiple perspectives and listens openly to others’ points of views.

  • Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.

  • Demonstrates ownership of results within (and beyond) area of responsibility.

  • Looks for opportunities for continuous improvement.

  • About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

    ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.