PROFESSIONAL PROFILE:

• Certification in Regulatory Medical Writing
• Licensed Clinical Pharmacist with over 10 years of experience in a retail setting, and 5 years of experience in medical writing
• Competent in searching PubMed and Google Scholar for medical literature
• Knowledgeable in pharmacotherapeutics of drugs and biologics, extemporaneous compounding, and disease states allowing for an effective therapeutic alliance with patients and their care
• Experienced in pharmacy law administration and community development, offering an exceptional foundation for unique professional and interpersonal skills
• Highly regarded as a creative problem solver who is composed under pressure with a proven record of success in program management, crisis management, conflict resolution, and personnel supervision
• Outstanding interpersonal communication skills with the ability to establish positive relationships with customers, pharmaceutical representatives, medical professionals, healthcare organizations, insurance providers, and pharmacy staff
• Proficient in Microsoft Word and Excel applications

PERSONAL SKILLS:

• Detail Oriented
• Problem Solver
• Committed
• Adaptable

PROFESSIONAL EXPERIENCE:

Confidential

Independent Contractor

Responsibilities:

• Conduct literature searches and review medical literature for the identification of supporting data for Company Core Data Sheets (CCDS)/Company Core Safety Information (CCSI)
• Prepare narrative summaries of literature and spontaneous postmarketing case reports for supporting listed adverse reaction data
• Review regulatory drug submissions to obtain supporting information for product labels
• Prepare tables showing comparisons of labeling information between local country product monographs and various compendia

Confidential

Independent Contractor

Responsibilities:

• Contractor supporting the Prescription Drug Labeling Improvement and Enhancement Initiative, with direct access to secure FDA research tools, internal documents and training materials
• Executed comprehensive medical database (Pharmapendium, PubMed, etc.) and scientific literature searches to update and verify drug label content, with a focus on adverse reactions and drug interactions
• Applied medical and clinical knowledge during review and summary of relevant scientific literature and tertiary compendia
• Collaborated with diverse teams of on - and off-site physicians, drug safety experts and offshore consultants to modify older prescription drug labels and write new content in the Physician Labeling Rule (PLR) format
• Prepared ad hoc reports responding to specific queries from medical experts
• Evaluated individual case reports and authored summary narratives to support drug interactions and adverse reaction data
• Managed individual timelines and prioritized tasks to conform to the team’s goals

Independent Medical Writer

Confidential

Responsibilities:

• Conduct literature searches and review medical literature for the identification of supporting data for Company Core Data Sheets (CCDS)/Company Core Safety Information (CCSI)
• Prepare narrative summaries of literature and spontaneous post-marketing case reports for supporting listed adverse reaction data
• Review regulatory drug submissions to obtain supporting information for product labels
• Prepare tables showing comparisons of labeling information between local country product monographs and various compendia

Global Safety Surveillance & Epidemiology Intern

Confidential, Collegeville, Pennsylvania

Responsibilities:

• Assembled Periodic Safety Update Reports (PSURs) and Annual Product Evaluation Reports (APERs) with relevant data from stakeholders
• Conducted searches of the internal adverse event reporting database and compiled the information for internal pharmacovigilance activities
• Performed literature searches for reports of adverse reactions and background disease state information

Dispensing Pharmacist

Confidential, Trenton, New Jersey

Responsibilities:

• Educate, mentor, and supervise an ancillary staff dispensing an average of 1,000 to 1,250 prescriptions weekly while maintaining inventory, work flow, and internal processes
• Compound and dispense prescriptions while relaying accurate dosing information
• Ability to manage a high volume of patient accounts while maintaining accurate patient records
• Provide patient counseling for prescription and non-prescription medications
• Consult with physicians and patients concerning disease state management, medication indications, dosage, side effects, drug/food interactions, and potential medication delivery problems and medical devices/equipment
• Interact with HMOs and other insurance providers concerning billing and reimbursement issues
• Stay current with ever changing developments in the pharmaceutical industry through continuing education, certifications, and personal research

Co-Chair and Founding Member

Confidential, Jackson, New Jersey

Responsibilities:

• Co-founder of a volunteer not-for-profit foundation, established to raise funds and award leadership scholarships to young adult students in Jackson, New Jersey
• Public liaison for establishing community involvement and sponsorship for fund-raising events
• Responsible for monitoring budgets, event organization, public relations, and marketing
• Coordinate social media activities

Project Manager

Confidential, Philadelphia, Pennsylvania

Responsibilities:

• Managed the Philadelphia Land Development Project, a project to help non-profits expand their businesses
• Coordinated legal activities with clients to gather, draft, and organize project information
• Counseled clients and organizations on the development and progression of projects/accounts
• Communicated on behalf of clients with: financial groups, real estate agents, home owners, grant writers, Philadelphia City Representatives, charter-school directors, government agencies, private foundations, and attorneys
• Drafted and submitted applications for financial grant awards
• Compiled contracts, letters of recommendation, narratives and letters of inquiry for client files

Court Services Officer Intern

Confidential, Jersey City, New Jersey

Responsibilities:

• Intimately involved with all aspects of case management and case flow from intake to disposition
• Coordinated the daily calendar of tenancy litigants in the courtroom and monitored mediation sessions
• Recorded information from automated system reports to gauge and improve the team’s efficiency in daily work completion, case disposition, and case financial assignment
• Processed case documents in accordance with New Jersey Statutes including Warrants of Removal and Dispositions