Life Sciences Regulatory & Policy Consulting Professional

Cyfle•Columbia, WA

15d•Hybrid

About The Position

We have partnered with a large law firm in the Washington, D.C. area to provide them with a Life Sciences Regulatory & Policy Consulting Professional. Please review the below description and let us know if you are interested. Our practice is well-recognized for supporting several landmark client initiatives in the field including patient community-led: (i) design and launch of a global clinical trial network; (ii) drug development guidance; (iii) patient experience data platforms; and innovative clinical trial strategies. Our engagements span the drug development and commercialization process from innovation in the lab through payer value determinations and market access. Ideal candidates will have experience in complex project management. They will be expected to manage or co-manage multiple projects, prepare analysis and presentation materials, support development of survey instruments and related tools, and manage meetings of various sizes, often with external stakeholders. They will have a working knowledge of the FDA regulatory process. Experience with the FDAs emphasis on patient-focused drug development will be a plus. They will understand the biomedical research and public health domains. They will appreciate the healthcare policymaking interface more broadly and be able and willing to work on clients' issues touching multiple HHS agencies including the NIH, FDA, CMS AND CDC. In all, the ideal person will be able to manage projects ranging from those supporting clinical/regulatory approaches to those supporting commercial/strategic decisions. The successful candidate may also engage on public policy issues pertaining to the topics, including supporting legislative or regulatory advocacy that may require registration under the Lobbying Disclosure Act.

Requirements

5-10 years of experience in the LIFE SCIENCES with a passion for patient-centricity in drug development.
Superior written and oral communications abilities, including the ability to deliver information to both internal and external recipients and to persuade recipients to accept a point of view (strong working knowledge of PowerPoint and presentation design to influence decision-making important)
A working understanding of the FDA regulatory process, including an understanding of relevant regulatory science and related issues
Ability to think critically including the ability to anticipate and address potential challenges or impediments
Ability to understand and synthesize complex regulatory and policy issues
Ability to manage multiple client priorities concurrently
Demonstrated willingness to work hard, do what it takes, and drive toward results
A track record of working effectively in teams while being able to operate independently to execute deliverables
This position is hybrid, but candidates must be based in the Washington D.C. area with access to our office.
No sponsorships or visa holders.
No Corp-to-Corp.

Nice To Haves

Experience with the FDAs emphasis on patient-focused drug development

Responsibilities

manage or co-manage multiple projects
prepare analysis and presentation materials
support development of survey instruments and related tools
manage meetings of various sizes, often with external stakeholders
engage on public policy issues pertaining to the topics, including supporting legislative or regulatory advocacy that may require registration under the Lobbying Disclosure Act