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Communication, Compliance, and Planning (CCP) Resume Example

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COMMUNICATION, COMPLIANCE, AND PLANNING (CCP)
Skill Highlights
FDA regulations (including GxP) and ICH guidelines pertaining to all stages of drug development (from preclinical to clinical phases I-IV). Experience with IND, CTA, BLA, NDA, eCTD regulatory submissions and project management. Proficiency with MS Word, Excel, PowerPoint, Outlook, Project, and Adobe Acrobat, SharePoint, electronic document management systems, databases.
Professional Experience
SanofiJanuary 2015 to CurrentCambridge, MA
  • Health Economics and Outcomes Research (HEOR), Global Market Access Centre of Excellence HEOR Graduate Co-op Conduct systematic literature reviews using various sources (e.g.
  • Pubmed, Embase, Medline) and generate evidence to substantiate value potential for two key oncology assets (SAR650984, Jevtana).
  • Review competitive landscape, communicate with external stakeholders and assist in the development of economic models in support of pricing and reimbursement strategy.
  • Apply research best practices in epidemiology and provide timely and strategic HEOR recommendations to clinical development programs aimed at ensuring differentiation for Payer value demonstration.
  • Evaluate relevant HTA decisions to determine value drivers and apply key learnings to Sanofi pipeline and marketed products.
Takeda PharmaceuticalsApril 2014 to December 2014Cambridge, MA
Global Regulatory AffairsSeptember 2014 to December 2014Communication, Compliance, and Planning (CCP)
April 2014 to September 2014Global Regulatory Intelligence and Strategy Associate
  • Monitored the U.S.
  • and international regulatory environment for new draft and final guidance documents, proposed and final regulations and new or revised agency policies.
  • Identified regulatory and legislative trends and changes with potential to impact the development and marketing of Takeda products and pipeline globally.
  • Prepared and published Takeda's regulatory e-newsletter distributed weekly across global sites.
  • Identified gaps and challenges in the function of the newly defined Global Regulatory Intelligence (GRI) department and recommended solutions. Submissions and Information Management (SIM), Global Regulatory Affairs.
Regulatory Affairs Associate
  • Led and trained a team of nine Regulatory Affairs Associates on a data migration project and created work instructions and templates that improved resource productivity by 25% and reduced project lead times by 50%.
  • Updated electronic databases in support of product registration tracking and regulatory information management for Takeda's marketed products.
  • Developed processes to ensure regulatory compliance with domestic and global regulatory filing requirements.
  • Specific tasks included data entry of new/updated content from approval documents to Excel spreadsheets/platforms and quality check of completed work.
  • Supported Global Regulatory Operations (GRO) and Global Regulatory Leads (GRLs) in Europe, Asia and Latin America to identify and communicate a list of submission and marketing authorization requirements by country.
Kavasakalis PharmacyOctober 2008 to July 2013Retail Pharmacy Manager
Athens, Greece
  • Created and implemented Standard Operating Procedures (SOPs) and workplace practices that maximized pharmacy's annual profits and saved above $40,000 annually on consulting costs.
  • Trained two pharmacists and three pharmacy technicians on dispensing prescriptions and scheduled their work to ensure pharmacy's peak performance.
  • Ensured continual compliance with all state and federal laws and regulations.
  • Monitored patient medication records by creating and maintaining unique patient profiles based on dispensed prescriptions and communications with other healthcare providers.
  • Communicated policy and procedure changes, system enhancements and clinical updates to all pharmacy staff by scheduling internal bi-weekly meetings.
Onassis Cardiac Surgery CenterApril 2008 to July 2008Pharmaceutical Intern
Athens, Greece
  • Prepared pediatric dosage forms under the direct supervision of the Chief Pharmacist.
  • Participated in patient education programs as a healthcare professional speaker.
Bornovas PharmacyJuly 2007 to April 2008Pharmaceutical Intern
Athens, Greece
  • Ensured adequate control and documentation of all controlled substance records by submitting monthly reports to federal regulatory authorities.
  • Documented interventions, adverse drug reactions and formulary changes into appropriate databases.
Education and Training
Northeastern UniversityJune 2015Master of Science: Regulatory Affairs for Drugs, Biologics, and Medical DevicesBoston, MAGPA: GPA: 3.87Regulatory Affairs for Drugs, Biologics, and Medical Devices GPA: 3.87
New Drug Development: A Regulatory Affairs Overview, Project Management in Early Drug Discovery, Advertising and Promotion of Drugs and Medical DevicesGPA: International Scholarship for the Study of International Regulatory Affairs, Academic Excellence Scholarship, Experiential Learning Award NomineeInternational Scholarship for the Study of International Regulatory Affairs, Academic Excellence Scholarship, Experiential Learning Award Nominee
Queen's University BelfastDecember 2013Postgraduate Diploma: Community PharmacyBelfast, UKGPA: Distinction for Academic ExcellenceCommunity Pharmacy Distinction for Academic Excellence
National and Kapodistrian University of AthensSeptember 2008Bachelor of Science: PharmacyAthens, GreecePharmacy
Professional Affiliations
Regulatory Affairs Professional Society (RAPS) Drug Information Association (DIA) The Food and Drug Law Institute (FDLI)
Publications
Sergi Efstathia, Impact of global warming on malaria and dengue in Africa: prevention and control through regulation. Abstract accepted for poster presentation at the DIA 2015 51st Annual Meeting, Washington, DC, June 14-18, 2015. Competitive selection process with selected student presenters awarded an all-expense paid trip to the DIA conference. Hatziantoniou Sophia, Sergi Efstathia, Korezelidou Sophia, Nanoemulsions and solid lipid nanoparticles incorporating retinyl palmitate, European Journal of Drug Metabolism and Pharmacokinetics, 2009, Volume 34, Special Issue, pp 93-94, ISSN 0378-7966, 14th Pan-Hellenic Pharmaceutical Congress, Athens, Greece, May 9-11, 2009. CERTIFICATION National Institutes of Health Office of Extramural Research April 2014 Protecting Human Research Participants (License 1437274)
Skills
Adobe Acrobat, Advertising, agency, bi, competitive, consulting, content, data entry, data migration, databases, document management, documentation, drivers, Economics, filing, forms, IND, Latin, marketing, Market, meetings, Access, Excel spreadsheets, Excel, Outlook, PowerPoint, MS Word, newsletter, peak, policies, pricing, processes, project lead, Project Management, Promotion, professional speaker, quality, Research, scheduling, strategy, strategic, supervision, unique
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Resume Overview

Companies Worked For:

  • Sanofi
  • Takeda Pharmaceuticals
  • Global Regulatory Affairs
  • Kavasakalis Pharmacy
  • Onassis Cardiac Surgery Center
  • Bornovas Pharmacy

School Attended

  • Northeastern University
  • Queen's University Belfast
  • National and Kapodistrian University of Athens

Job Titles Held:

  • Communication, Compliance, and Planning (CCP)
  • Global Regulatory Intelligence and Strategy Associate
  • Regulatory Affairs Associate
  • Retail Pharmacy Manager
  • Pharmaceutical Intern

Degrees

  • Master of Science : Regulatory Affairs for Drugs, Biologics, and Medical Devices
    New Drug Development: A Regulatory Affairs Overview, Project Management in Early Drug Discovery, Advertising and Promotion of Drugs and Medical Devices
    Postgraduate Diploma : Community Pharmacy
    Bachelor of Science : Pharmacy