Jessica Claire
Montgomery Street, San Francisco, CA 94105
Home: (555) 432-1000 - Cell: - - -
Professional Summary

Knowledgeable Biotechnology and Pharmaceutical professional with 9 years of industry experience working in various functions including; commercial operations, marketing, regulatory, business development, medical affairs and clinical trials. I am well organized, diligent, and adept at coordination and management of various projects, products, and functions. Highly collaborative and hard working with clear and concise attention to details.

  • Change Management
  • Compliance assurance
  • Project Management
  • Problem resolution
  • Process improvement
  • Product Information
  • Standard operating procedures
  • Product portfolio oversight
  • Submission preparation
  • Business operations
  • MS Office
  • Federal Drug Administration
  • Risk mitigation and strategy
  • Operational planning
Work History
04/2017 to 02/2020
Director of Regulatory Affairs Cello Health Florham Park, NJ,
  • Collaborated with principal investigators and sponsors to facilitate review and documentation of clinical trial activities.
  • Ensured alignment of regulatory strategy and plan on a continuous basis with the GRA Management Team and key cross-functional stakeholders.
  • Completed review of informed consents and subsequent amendments.
  • Drove operational improvements which resulted in savings and improved profit margins by 30% annually.
  • Resolved conflicts and negotiated mutually beneficial agreements between sponsors, collaborators, principal investigators and regulatory agencies.
  • Worked with governance committees to review, edit, and evaluate promotional activities including: print, digital, and social media tools and tactics.
  • Managed resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets were available to deliver the project deliverables.
  • Analyzed trial studies, data reports, compiled information, and submitted concise and informative summaries to sponsors, regulatory agencies and investigate sites.
  • Reviewed promotional materials, protocols and contracts; to ensure state, federal, global, and industry guidelines were adhered to.
  • Directed and coordinated with US and Global regulatory authorities and representatives to manage filings, applications and reports.
  • Determined appropriateness of phase 1-phase IV clinical trials and retrospective analysis to protect patients, sponsors, investigators and collaborators to determine and minimize appropriate risks.
  • Monitored social media and online sources for industry trends and guidelines for development of advertising and promotional materials.
  • Monitored and created control reporting to track performance of systems, process integrity, vendors, internal workflows and SLAs.
  • Implemented KPI tracking dashboard and online document management system; resulting in increased efficiencies and shortened review timelines.
  • Coordinated submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial submissions, new marketing authorizations applications, etc. + monitored the development of new regulatory requirements or guidance documents and advised product teams of the impact on the business or development programs.
05/2014 to 04/2017
Sr. Marketing Communications Specialist Cardiovascular Systems Inc Pearland, TX,
  • Partnered cross-functionally to facilitate marketing opportunities supporting brand objectives.
  • Managed Promotional Review Committee process and meetings for companies top product franchise helping to achieve sales goals and revenue objectives.
  • Ensured compliance and change control process with GMP, SDLC, FDA and additional regulatory body requirements.
  • Drove requirements gathering, RFP process and led implementation for Veeva Vault, QualityDocs, RIM, eTMF, CTMS, Clinical Conductor and PromoMats.
  • Resolved conflicts and negotiated mutually beneficial agreements with cross functional teams including: regulatory, legal, medical, compliance, marketing. sales and public affairs.
  • Managed manufacturing process including development of SOPs, audits and quality docs for TECFIDERA sampling program and drug distribution.
  • Managed 2253 submission process including both hard copies and electronic submissions..
  • Developed training modules and conducted live training on GMP, Sales Force, CRM, and Veeva tools.
  • Developed marketing communications and promotional review committee handbook which included: industry standards, process related documents, tools and tips, and key contacts resulting in increased efficiencies within the commercial function.
  • Launched various blockbuster and novel specialty products and facilitated marketing material submissions, prioritization, timelines, review, and dissemination.
  • Managed RFP process and implementation of print managed services and fulfillment vendor.
  • Partnered with technical teams and cross functional partners to implement VEEVA vault and Sales Force including transferring legacy systems data and conducted systems training.
  • Managed team of promotional review committee consultants.
  • Developed product sampling SOP, compliance documents, regulatory filings, and managed vendor operations.
04/2011 to 06/2013
Product Marketing Manager Patra El Paso, TX,
  • Managed product development lifecycle and timelines from conception to dissemination.
  • Developed marketing content such as blogs, promotional materials and advertisements for social media.
  • Created digital treatment algorithm for patients, providers, and payers to calculate their chance of achieving a cure with INCIVEK; based upon US prescribing information and applicable clinical trials data inclusive of retrospective analysis.
  • Commercial marketing lead for implementation of digital asset management tool and online review of promotional product materials.
  • Partnered with cross functional colleagues for RFP, selection, and implementation of print managed services vendor resulting in 38% annual promotional print savings.
  • Partnered with labeling and manufacturing for development of INCIVEK packaging design, production and distribution.
  • Managed and implemented fulfillment vendor for both commercial and medical materials. Developed materials for and conducted applicable trainings.
  • USPI and global label update lead including the prioritization of promotional and medical materials to ensure regulatory deadlines were met.
  • Developed product blister packaging working with labeling and manufacturing.
  • Built and strengthened strategic relationships with vendors, advertising agencies and cross functional colleagues.
  • Conducted quarterly business reviews of agency partners leading to increased efficiencies and cost savings.
Expected in 2011
Bachelor of Science: Marketing Management
Western Governors University - Salt Lake City, UT,
Expected in
Master of Science: Neuroscience
Massachusetts Institute of Technology - Cambridge, MA
  • Foster Rosenblatt Marketing Pharmaceuticals
  • Project Management Professional (PMP)
  • Visio
  • Salesforce
  • Veeva Vault

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School Attended

  • Western Governors University
  • Massachusetts Institute of Technology

Job Titles Held:

  • Director of Regulatory Affairs
  • Sr. Marketing Communications Specialist
  • Product Marketing Manager


  • Bachelor of Science
  • Master of Science

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