Mary Ellen Freed, M.S

*** ****** ****** • Philadelphia, PA 19148

215-***-**** • ac0s2l@r.postjobfree.com

https://www.linkedin.com/in/mary-ellen-freed-8a775617/

CLINICAL RESEARCH PROFESSIONAL / REGULATORY & TECHNICAL WRITER

Dedicated professional repeatedly recognized for exemplary performance working in global data management teams, possesses exceptional communication and active listening skills; easily establishes consensus among work groups and collaborate effectively with staff at all levels, including C level executives. Provides solid resolution skills when faced with challenges in conducting global studies.

Highly regarded Technical Writer with over 10 years of experience developing instructional documents, and training materials for global pharmaceutical corporations; expertise creating policies, standards, procedures, templates, processes. Delivered 100% compliant documents during a 5-year consent decree period, with no 483 findings. Ensures all documents comply with established specifications and regulations and that materials are accessible to scientific readers. Possess comprehensive knowledge of GMP, GCP, GxP and ICH guidelines; serve as SME and provide ongoing support and guidance to cross-functional teams across the globe regarding regulatory requirements and intelligence.

SOP Development • Training & Development • Data Management

User Acceptance Testing • Script Development • Project Management

professional experience

McNeil Consumer Healthcare, Fort Washington, PA • 8/2012 - 3/2017

Lead Compliance Specialist - JJRC (McNeil Oversight)

Reviewed Quality Standards, Standard Operating Procedures (SOP's), Work Instructions and functional documents/operational guidelines for the Home Office Regulatory Compliance. Collaborate with departmental personnel to understand/analyze procedures, gather information, address issues, resolve problems and implement change, and ensure procedures are consistent across associated documents and sites for the Consent Decree effort. Performed gap assessments to global regulations using a trace matrices tool that I developed.

Project Manager for the on-boarding of TrackWise and oversight of internal audits.

Achieved third party verification of procedures during consent decree enabling quality system verification.

Designed and implement standards gap assessment tool to compare regulations for global product placement.

Research Pharmaceutical Services (RPS), Inc., Fort Washington, PA • 11/2009-3/2012

Procedural Developer for RPS-IT

Create, modify, and introduce Clinical Research departmental documents, such as SOPs, forms, and IT manuals for leading provider of phase 1-4 clinical development solutions.

Developed IT Work Instructions for a physician’s payment tracking system for the client Vistakon.

Reconciliation of trial master file and outstanding clinical trial documents from Investigator sites.

Contact to Clinical Investigator sites for the reconciliation of clinical study documents.

Procedural Developer – Actelion (client)

Appointed to create and remediate procedural documents and internal training materials for Clinical Operations, including Healthcare Compliance for Actelion Pharmaceuticals, and served on start-up team that conceived and designed training/development program.

Concise consolidation of all procedural documents.

Implemented the e-Learning and Development for launch of training programs. Ensure content is accurate and on target for the training audience.

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Mary Ellen Freed, MS • Page 2 of 3 • ac0s2l@r.postjobfree.com

Professional Experience (continued)

Merck Research Labs, Upper Gwynedd, PA • 2/2008-11/2008

Associate Clinical Research Specialist

Conducted comprehensive protocol reviews to ensure study endpoints and prepared clinical study reports. Established and maintained relationships with investigators. Review of safety labs for critical data. Performed literature searches for clinical studies. Prepared PSUR’s for global submission to regulatory authorities; drafted safety narratives for adjudication projects and conducted safety reviews of lab data. Participated in clinical study teams.

Recognized by the therapeutic area Medical Director for accurate, clear and concise reporting.

Designated as primary author for all PSURs for our team.

J&JPRD, CNS/IM, R&D Operations, Titusville, NJ • 10/2005-11/2007

SOP Developer

Developed and implemented standard SOPs and other associated forms and templates for multiple R&D departments, identified document properties and user groups for storage in EDMS. Developed content and performed quality checks of e-learning modules. Ensured documents met regulatory requirements and were consistent with departmental practices. Developed training modules and wrote story boards.

Received Encore Platinum and Silver Awards for demonstrating leadership, customer focus, and strategic thinking, while emphasizing staff development.

Fox Chase Cancer Center, Fox Chase, PA • 3/2005-10/2005

Regulatory Supervisor, Clinical Research Unit

Directed daily unit operations, including assigning protocols for review to the IRB, IRB document review, editing and submission, drafting SOPs, maintaining and editing regulatory documents, informed consent updates for the sponsor and liaising with pharmaceutical companies, CRAs and CROs. Primary point of contact for study monitors, regulatory agencies, and cooperative groups. Managed Safety Reporting program and staff for reporting to agencies and sponsors.

Eliminated IRB document review backlog within 1 month allowing Investigators more timely choices.

Wyeth Pharmaceuticals / Accenture, Collegeville, PA • 12/2001-3/2005

Lead Data Manager / Clinical Data Management

Collaborated with clinical team members during study status meetings. Directed projects to ensure timely completion of key milestones. Managed clinical trial database deliverables from study start-up to study completion. Developed the data management plan and validation checks to new databases and cleaning of data for final database lock. Developed data scripts and performed user acceptance testing. Preparation of clinical supplies and drug. CRF development and protocol review. Performed electronic CRF development pilot. Served on the electronic data capture initiative.

Implemented remote training and certification program to a data management team in Bangalore, India.

Developed a live training session, employing a game model that drew popularity throughout the organization.

Liaised with our CRA in Beijing, China to pull the last critical data in one visit from a hospital during the SARs epidemic. 100% of the data was retrieved on time.

Covance, Inc., Princeton, NJ • 6/2000-12/2001

Lead Data Manager- Clinical Research

Managed all aspects of data collection, review, and documentation and reconciled AE reporting. Developed data scripts and performed user acceptance testing. Liaised with clinical team members in weekly team meetings. Ensured all study deliverables for Data Management were met from study start-up to study completion and database lock.

Received Bravo Award for successful study completion; promoted to position of study lead within 6 months.

Recognized valuable team player in building successful sponsor relationships, via a sponsor questionnaire.

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Mary Ellen Freed, MS • Page 3 of 3 • ac0s2l@r.postjobfree.com

Professional Experience (continued)

Janssen Pharmaceutica, Titusville, NJ • 11/1995-6/2000

Documentation Coordinator - Stability Laboratory

R.W. Johnson Pharmaceutical Research Institute, Raritan, NJ • 9/1990-11/1995

Senior Clinical Data Coordinator

Responsible for all aspects of data collection, coding, medical review, and documentation. Performed data entry of all AE’s/SAE’s up to final reporting into the safety database. Developed data scripts and performed user acceptance testing. Wrote safety narratives. Consulted with study sites to resolve queries, complete current site essential documents, and address data issues.

Education & Technical Proficiencies

Master of Science in Quality Assurance & Regulatory Affairs

(GMP, GCP, GxP curriculum)

Temple University School of Pharmacy – Philadelphia, PA

Bachelor of Arts in Journalism & Advertising

Temple University – Philadelphia, PA

Proficient with Oracle, Pharmadoc, TrackWise, EDMS (Documentum), ComplianceWire, Sumtotal (e-training software), and Microsoft Office 365 Suite, including Word, Excel, SharePoint and PowerPoint.

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