Clinical Research Registered Nurse

MARY ELLEN DRONITSKY, RN, MBA, JD

Phone: 610-***-**** E-Mail: *********@*******.***

PROFESSIONAL EXPERIENCE

Aegerion Pharmaceuticals, Cambridge, MA, Senior Director, Global Labeling and Regulatory Affairs- Advertising and Promotion, 2017-Present

Head of Regulatory Advertising Promotion responsible overseeing process for reviewing promotional and sales training materials and collaborating with multidisciplinary team to find solutions to ensure materials are consistent with approved product labeling

Member of Compliance Committee to implement and oversee Corporate Integrity Agreement, REMS Consent Decree

Chairperson for Global Labeling Committee to review and recommend changes for product labeling including interfacing with pharmacovigilance to update labeling in response to safety and adverse event reports

Genzyme, Cambridge, MA, Director, Regulatory Advertising and Promotion, 2014-2017

•Leadership role responsible for directing and mentoring direct reports and Pharm D fellows for review of promotional materials including patient materials, professional health care provider materials, sales training, press materials, corporate materials as well as materials for developmental products

•Consulted with core Regulatory Team regarding US labeling updates and ensured changes were reflected in promotional materials

•Provided regulatory advertising and promotion advice and strategic leadership to Multiple Sclerosis Brand Team in launch of new product and provide regulatory advertising guidance for rare disease products and biosimilar products

•Participated on corporate steering committee for Regulatory Advertising and Promotional Excellence charged with developing regulatory standards and policies across Sanofi companies

•Participated in pioneering team on the roll out a new electronic review system

•Submission of materials to OPDP including 2253s, request for advisory comments, sub part e and h

Northeastern University, Boston, MA, Adjunct Teaching Professor, 2015-Present

Teach online course in FDA Regulatory Advertising and Promotion of Drugs and Medical Devices for MS Regulatory Affairs Program in the College of Professional Studies

Temple University, Philadelphia, PA, Adjunct Assistant Professor, 2009- Present

Teach live and online courses in Food and Drug Law and FDA Regulation of Prescription Drug Promotion for the Graduate RA/QA MS in the School of Pharmacy

Designed and developed new course and content for FDA Regulation of Advertising and Promotion

GlaxoSmithKline, Philadelphia, PA, Director Regulatory Promotion and Policy, 2011-2014

•Provide strategic and operational leadership to Oncology Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion for the US market in accordance with business goals and objectives, FDA regulation, ICH guidelines, PhRMA guidelines and company policy

•For assigned products, provide sound regulatory advice that minimizes the risk of regulatory and legal action, competitively positions assigned products and is consistent with applicable FDA regulations and GSK policies for advertising and promotion of prescription drug products and biologics

•Effectively communicate with reviewers within US FDA Office of Prescription Product Promotion (OPDP, formerly DDMAC) that expedite resolution of issues relating to assigned products

•Participated on US labeling review teams for assigned marketed products

•Participate in company, government and trade association working groups that focus on advertising and promotion standards and guidelines

Bristol-Myers Squibb, Princeton, NJ, Director, US PHARMA Law and Promotion Compliance, 2010-2011

•Led Regulatory Promotion Compliance Group for PLAVIX

•Managed interactions and regulatory submissions with FDA/DDMAC

•Collaborative with Medical and Commercial Organization to insure development of promotional programs that are compliant with state and federal law, regulatory guidelines and Company policy, while supporting achievement of business objectives

•Provided expert regulatory review of branded and unbranded consumer pieces including television advertisements and websites; health care professional materials including speaker programs, e-detailing and FDAMA 114 items

•Provide expert risk advice on federal and state law and FDA regulations governing the promotion and marketing of prescription pharmaceutical products

Towers Watson, Philadelphia, PA; (Temporary) Senior Counsel, Commercial Contacts; 2009-2010

Encorium Group, Inc., Wayne, PA; In-House Counsel and Director, Contracts; 2006 – 2009

•Monitored changes in proposed FDA regulations and draft guidances to advise management interpretation, strategy and possible impact and implications.

•Reviewed press releases and promotional materials for regulatory compliance

•Drafted and negotiated US and international commercial contracts with sponsors, customers, vendors and hospitals and complex agreements related to clinical and regulatory services with domestically and international sponsors for new drugs and devices including publication and termination provisions

•Analytically assessed business and regulatory risk and advised senior management

•Collaborated with a multi-disciplinary team to develop contracts for clinical trial services which included data management services, regulatory affairs, IVRS, central labs and other data capture devices

•Developed procedures and contract templates for pharmaceutical company clients, vendors, and therapeutic expert consultants involving clinical trials and related services

Wyeth, Collegeville, PA; Associate Director, Regulatory; 2002 - 2006

•Member of US and Global Advertising and Labeling Review Team for Marketed Products that reviewed and revised promotional pieces for DDMAC submission and product labeling that were acceptable to both FDA and Wyeth’s marketing and legal departments

•Lead liaison with FDA (CDER, CBER, DDMAC) for group of products.

•Responsible for developing and signatory party for submissions to FDA on a group of products including NDAs, BLAs, labeling supplements, efficacy supplements, CMC reformulations and annual reports in accordance with 21 CFR that resulted in multiple approvals.

•Member of Task Force that developed templates and procedures for electronic submissions based on Common Technical Document.

Versicor, Inc, King of Prussia, PA; Counsel, Sr. Manager, Contracts and Clinical Trials; 2001 - 2002

•Negotiated and drafted contracts and letters of agreement and indemnity with physicians,

Universities, hospitals, CROs (Clinical Research Organizations), laboratories and contract manufacturers.

•Negotiated settlements and resolved disputes over budgets and scope of work issues while preserving professional relationships between parties.

•Managed and administered grants and contracts for research projects.

•Provided advice on HIPPA privacy regulations and ICH guidelines and GCPs.

•Drafted patient consent forms in accordance with FDA regulations per 21 CFR and guidelines.

Private Legal Practice; Attorney; 1994-2000

•Areas of Practice: FDA Regulatory and Compliance and Contracts, Product Liability, Medical Malpractice, Employment and Labor Law, Litigation, Discovery, Pleadings, Court Motions, Expert Witnesses, Trials and Settlement Negotiations

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Merck Research Laboratories, Blue Bell, PA; Clinical Research; 1987-1993

•Drafted IND reports, safety updates and sections of New Drug Applications.

•Designed and implemented a plan to audit clinical studies for adherence to FDA regulations and Good Clinical Practices.

•Developed a management audit reporting system for serious adverse experiences for a group of clinical studies as well as a corrective action plan.

•Contributed substantially to the drafting of a New Drug Application submitted to the FDA on schedule.

•Designed and implemented clinical studies to support advertising claims of marketed products. Initiated and monitored Phase I-IV clinical research projects for pharmaceutical agents in multiple therapeutic areas including OTC switches, pain and cardiovascular.

•Drafted study protocols, investigational drug brochures, and clinical study summaries.

•Coordinated with Legal, Marketing, Business Development, Pre-Clinical, Clinical and Regulatory Affairs Departments to facilitate product development. Managed research projects to completion on time and within budget.

ACADEMIC AND BAR ADMISSION CREDENTIALS

Admitted to Pennsylvania Bar and Federal District Court for Eastern Pennsylvania 1994

J.D., Temple University Law School, Philadelphia, Pennsylvania 1994

MBA, St. Joseph’s University, Philadelphia, Pennsylvania

M.S., Nursing, Adelphi University, Garden City, New York

B.S., Nursing, William Paterson University, Wayne, New Jersey Licensed Registered Nurse - Pennsylvania

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