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.
Skills
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 AffairsCello 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 ManagerPatra – 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.
Education
Expected in 2011
Bachelor of Science: Marketing Management Western Governors University - Salt Lake City, UT, GPA:
Expected in
Master of Science: Neuroscience Massachusetts Institute of Technology - Cambridge, MA GPA:
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