Montgomery Street, San Francisco, CA94105(555) 432-1000, resumesample@example.com
Professional Summary
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Dedicated pharmacy professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Skills
20+ years of delivering presentations and training
Excellent researching and writing ability
Proven ability to quickly become therapeutic area expert
Proven ability to build and maintain professional working relationships
Excellent written and verbal communication skills
Attention to detail, with multitasking abilities
Work History
10/XXX1 to CurrentRegulatory SpecialistApex Systems | Fuquay Varina, NC,
Interpret regulatory rules or rule changes and communicate with others through policies and procedures.
Prepare and submit regulatory file applications and supporting documentation.
Perform and document quality control checks to maintain compliance with department initiatives.
Prepare and document inventory for core dossier preparation in collaboration with Regulatory Affairs Manager.
Recommended improvements to processes, leading to improved collaboration between monitoring unit and regulatory unit for protocol and case record form development.
11/2008 to 08/XXX1Staff PharmacistCvs Health | Pittsfield, MA,
Performed drug utilization reviews pertaining to prescriptions in therapeutic areas that include: Rheumatoid Arthritis, Immunology, Endocrine, Oncology, Multiple Sclerosis, Hepatitis C, HIV
Assessed medication therapy outcomes for autoimmune diseases
Performed managed care and coverage review outreach to physician offices
Consulted patients on safe and appropriate drug utilization
Provided specific, unbiased, and timely responses to healthcare provider requests for drug information
Recognized, documented, and reported adverse events and product quality complaints according to policies and procedures
Reviewed latest clinical guidelines and new drug therapies
Delivered training and presentations on new drug launches
Reviewed and updated current Standard Operating Procedures [SOPs]
Reviewed and updated Dispensing and Practice Guidelines
Performed assessments of turnaround time reports to facilitate completion of aging orders in queues
Served as subject matter expert on new processing system, for specialty drugs based on agile technology
Performed validation of IT releases in new operating system
Delivered biweekly presentations to Rheumatoid Arthritis and Immunology team on system updates and new drug launches
Trained newly hired pharmacists on multiple processing platforms, disease states and drug therapies
Conducted cross-training sessions for pharmacists
Identified system flaws and misinterpretations of therapy regimens to ensure safe and effective patient care
Precepted pharmacy students on lifecycle of prescription and therapy related SOPs
08/2002 to 05/2007Graduate Research AssistantChildren's National Medical Center | Greenbelt, MD,
Provided comprehensive research assistance and support when designing and executing experiments.
Prepared materials for reports, presentations and submission to peer-reviewed journal publications.
Gathered, reviewed, and summarized literature from scientific journals such as SciFinder and PubMed and produced graphs and other scientific calculations using MS Excel.
Planned, modified, and executed research techniques, procedures and tests.
Contributed to professionally-written scientific paper for publication.
Maintained and calibrated equipment for precision and accuracy.
Educated undergraduate students on safe use of lab equipment and reagents and chemicals.
Helped team meet regulatory requirements by coordinating documentation and filings.
05/2000 to 07/2002Clinical and Regulatory Affairs ExecutiveElder Pharmaceuticals | City, STATE,
Prepared documents for review/approval and filing of global regulatory submission
Evaluated published medical and scientific literature and developed comprehensive standard response documents
Wrote and reviewed technical Quality/CMC regulatory documents for global regulatory submissions, ensuring compliance and alignment with global regulatory requirements and strategy
Managed, tracked and archived regulatory documents in an information management system
Presented key Quality/CMC updates to regulations, guidelines and processes, to project team
Provided scientifically accurate, clear and concise medical literature and trained marketing teams
Prepared final documents/dossiers on Phase III and post marketing trials and gave presentations to regulatory board
Education
Expected in 05/2007Ph.D. | Medicinal And Pharmaceutical ChemistryUniversity of Mississippi, University, MSGPA:
Expected in 05/2000Master of Science | Pharmaceutical SciencesMumbai University, Mumbai, India, GPA:
Expected in 05/1998Bachelor of Science | PharmacyMumbai University, Mumbai, India, GPA:
Certifications
Medication Therapy Management (MTM) Certified – American Pharmacists Association [APhA]
Rho Chi Member – Pharmacy Honor Society
Certificate of completion of GCP-ICH guidelines training program
Honors fellowship award, University of Mississippi
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