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Denise Benedict

Associate Director, IP Management & Regulatory Affairs SME and Business Process Owner @ Pfizer

Regulatory Affairs Strategy & Quality Business Process Liaison

Greater Philadelphia Area

Ranked #1,013 out of 20,260 for Associate Director, IP Management & Regulatory Affairs SME and Business Process Owner in United States

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Denise Benedict's Email Addresses & Phone Numbers

Denise Benedict's Work Experience


Associate Director, IP Management & Regulatory Affairs SME and Business Process Owner

July 2011 to December 2016

North Wales, PA, 19454


Sr. Regulatory CMC PM & Business Analyst

April 2010 to March 2011

Collegeville, PA

Johnson & Johnson

Regulatory Affairs Proofreading Project Manager in Labeling- OTC

March 2009 to August 2009

Fort Washington, PA

Denise Benedict's Education

Gwynedd Mercy Acadamy

High School diploma, College Prepatory

Villanova University

Essentials of Lean Six Sigma, Business of Professional Studies

2017 to 2020

Colorado State University

N/A, Wildlife Biology

1996 to 1999

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Strong sense of self

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About Denise Benedict's Current Company


•Responsible for leading the IP Management workstream for the PFIZER-ICON-PAREXEL Strategic Alliance Partnership (SAP).•Represented ICON as the IP Management & GMP Subject Matter Expert (SME) and the Business Process Owner (BPO) across all Pfizer-ICON protocols.•Acted as the primary point of contact with the Pfizer BPO on the PFIZER Pharm-Sci, Dev-Ops, CMC RA & IRT work streams.•Devised all...

Frequently Asked Questions about Denise Benedict

What company does Denise Benedict work for?

Denise Benedict works for Pfizer

What is Denise Benedict's role at Pfizer?

Denise Benedict is Associate Director, IP Management & Regulatory Affairs SME and Business Process Owner

What is Denise Benedict's personal email address?

Denise Benedict's personal email address is de****[email protected]

What is Denise Benedict's business email address?

Denise Benedict's business email addresses are not available

What is Denise Benedict's Phone Number?

Denise Benedict's phone (**) *** *** 190

What industry does Denise Benedict work in?

Denise Benedict works in the Pharmaceuticals industry.

About Denise Benedict

📖 Summary

Associate Director, IP Management & Regulatory Affairs SME and Business Process Owner @ Pfizer •Responsible for leading the IP Management workstream for the PFIZER-ICON-PAREXEL Strategic Alliance Partnership (SAP).•Represented ICON as the IP Management & GMP Subject Matter Expert (SME) and the Business Process Owner (BPO) across all Pfizer-ICON protocols.•Acted as the primary point of contact with the Pfizer BPO on the PFIZER Pharm-Sci, Dev-Ops, CMC RA & IRT work streams.•Devised all Clinical Trial Process Quality documents (CTPQS) and Clinical Quality Metrics for the ICON IP Management department in conjunction with the PFIZER Pharm-Sci & Dev-Ops teams. •Functioned as the IP Management SME/BPO for ~150 protocols, 5 CTPQS, and 13 METRICS. •Created, reviewed and approved process development work (operational-liaison of the CTPQS) as well as created more detailed "how to" guides/tools & templates as needed for ICON training.•Provided input into training material & initial training delivery of all IP management related systems and processes. •Functioned cross-functionally on all required decision making for the IP Management CTPQS and helped to identify areas where other departmental functions needed to provide process input. •Reviewed and provided input into training material & initial training delivery of all IP management related systems and processes.•Developed process responsibility (RASI) charts and task descriptions in the alliance-partner operating manual for IP Management & CMC Regulatory Affairs CTPQS documents.•Advised senior management of key developments on my work stream and their implications to ICON.•Managed the designated project in accordance with the agreed project planning (charter) and control documentation, including initiation and maintenance of the project plan.•Produced project status reports and executive summaries at agreed upon intervals to optimize my work stream to be the most efficient & effective it could be. From July 2011 to December 2016 (5 years 6 months) North Wales, PA, 19454Sr. Regulatory CMC PM & Business Analyst @ Pfizer •Supported the WYETH-PFIZER migration project for Regulatory CMC activities on the Product Information and Registration Tracking (PIRT) project while working with a team of client personnel to perform the analysis and design of the CMC Regulatory commitment tracking process.•Created the project’s proof of concept while identifying key gap analysis in order to further define the project’s scope.•Worked with a team of client personnel to analyze, define and prepare the CMC sections of product dossiers. •Ensured that the CMC sections of Pfizer dossiers were compliant with regulatory agency requirements.•Provided oversight and regulatory expertise while managing an off-shore & on-shore team of regulatory analysts.•Wrote, reviewed and maintained Pfizer SOPs for accuracy and Regulatory/GMP compliance.•Met project management goals by creating & delivering business, user and functional requirements, specifications and data flow design documents.•Experienced owning a defined work stream in the project and a demonstrated ability to manage issues and risks, and timely escalation. •Provided regulatory guidance and input for global product development processes (IND through A/NDA/BLA filing)•Gained experience with all stages of the electronic software development lifecycle (eSDLC) and Pfizer’s electronic lifecycle management. (ELC)•Developed executive summaries and design matrix for lifecycle deliverables.•Followed Pfizer’s validated electronic data archiving processes for GxP business processes. From April 2010 to March 2011 (1 year) Collegeville, PARegulatory Affairs Proofreading Project Manager in Labeling- OTC @ Johnson & Johnson •Lead regulatory promotional labeling activities for the Tylenol® Refresh project.•Reviewed multiple product submissions for compliance with the code of federal regulations as well as McNeil promotional style to ensure quality of the product dossier before publishing for submission.•Proofread monographs and product label copy as well as promotional labeling materials at artwork and thermal stages (including cartons, labels, trays, coupons, and shippers) to ensure 200% accuracy.•Created McNeil product spreadsheets for the company to better assist cross-functional areas with expiry dating, generic name, product components, manufacturing site locations, and drug listings. •Coordinated the 2009 McNeil drug listings for all assigned products. This included reaching out to our company partners’ including Marketing, Research and Development, Legal and Medical for the drug listing to be accurate and complete before submission to the FDA.•Coordinated with the Director of Regulatory Affairs to create the first electronic drug listing in structured product labeling (.xml format) to submit to the FDA in accordance with FDA specified timelines.•Utilized internal operating systems such as the McNeil electronic document management system (EDMS) and Viewpoint to send proofread materials through the McNeil review process in order to correct mistakes and inconsistencies within the product label copy.•Lead all Quality & Regulatory Affairs direction to ensure successful OTC brand and generic launch of newly approved products in the US and advise the EU and Asia Pacific regulatory PM'S of all approved DDMAC changes. From March 2009 to August 2009 (6 months) Fort Washington, PAClinical Pharmacy Representative– Oncology, Internal Medicine @ Pfizer •Responsible for maintaining 100% drug accountability and closing all clinical protocols for specific drug projects.•Verified drug accountability by notifying Medical Monitors and/or Regional Clinical Associate Management Team regarding missing documents. Communicated additional information received regarding unacceptable files.•Tracked all drug & non-drug expirations and notified all warehouses and Regional Clinical Associates of expiration.•Wrote and presented information regarding Clinical Trial Materials (CTMs) at investigator’s meetings as requested by CR&D.•Wrote and reviewed company and department SOPs, SPIs, and STAs as required.•Provided drug information for both clinical and marketed products to CR&D as required.•Ensured adequate drug supply throughout the course of the study along with the help and collaboration of CR&D.•Initiated packaging and labeling requests on all responsible clinical trials•Attended CR&D and Dev OP meetings in order to establish bulk and finished- goods manufacturing & packaging•Maintained & ensured that all protocol pharmacy files were in order for in-house audits, weekly. From July 2001 to January 2003 (1 year 7 months) Collegeville, PADirector Regulatory Affairs Strategy & Quality Business Process Liaison- Across all TA's @ Pfizer •Acts as single point of contact in the identification of suspected Quality Events (QE) and ensures corrective/preventive action (CAPA) plans are developed in response to Safety and Regulatory QE’s, audits, and inspections and that commitments are met in a timely manner.•Leads governance committees and designs and oversees tracking of business process metrics and remediation strategies reported to quality committees such as the Worldwide Safety & Regulatory (WSR) Quality Oversight Committee.•Develops, updates and maintains documents (SOPs, training programs) relating to WSR business processes. •Drives the end-to-end design, continuous improvement and oversight of existing processes/systems/controls to ensure that quality is built-in to enable consistent performance.•Participates on/leads cross functional teams to execute process improvements identified through the audit (or inspection) process.•Acts as single point of contact for audit and inspection support; works collaboratively with Safety and Regulatory Quality business units and therapeutic areas to support audit and inspection activities; develops audit remediation plans and tracking all actions to completion.•Provides process and project management support to WSR BUs in developing and maintaining core regulatory strategy deliverables such as the Label as Driver.•Develops, updates and maintains Quality Management Plans for WSR business processes.•Identifies and drives opportunities for consistency, standardization and continuous improvement of regulatory strategy business processes.•Supports internal and external inspections in collaboration with WSR SMEs and development of remediation plans and CAPAs. From March 2017 to 2018 (1 year) NYC & Collegeville, PAIRT Project Manager @ Almac Group •Performed project management responsibilities during the maintenance phase of assigned clinical trials such as; provided oversight of project quality, project budget, project status and communication with my clients, management of system change requests and oversight of task completion by project teams.•Served as the main client contact during the maintenance phase of the trial and delivered excellent customer service.•Met project management goals by writing and creating manual procedures and business reports such as randomizing patients when the client personal was not able to access the Almac interactive voice and/or web system (IXRS). •Provided support and oversight of assigned project teams. •Presented at Investigator Meetings and study start-up.•Chaired clinical and vendor team meetings to determine program outcome and direction.•Oversaw the tasks of assigned Project Specialist to ensure they were completed with quality and on time including; the translation of the IXRS, the translation and distribution of site materials, keeping study procedures/documents up to date, reviewing and approving their daily tasks and reviewing data modification. From September 2009 to March 2010 (7 months) Yardly, PACorporate Labeling Manager-Vaccines, Pyschiatry, Immunology, Oncology @ Sanofi •Chaired multi-discipline labeling working groups (LWG) in which I presented labeling proposals in order to achieve consensus. After a consensus was obtained, I presented the LWG proposal to the Corporate Labeling Review Committee for internal approval of proposed labeling.•Presented world-wide corporate Regulatory Affairs strategies to senior management bi-weekly.•Reviewed local labeling (worldwide) for compliance with S-A corporate labeling (core data sheet). This resulted in worldwide labeling that was consistent with S-A corporate labeling. •Developed product labeling based upon international study results and coordination of labeling review and approval throughout the company.•Prepared corporate, US and EU labeling documents (prescribing information, SmPC) for developmental (Investigational) and Life Cycle Management (LCM) products to obtain company and/or agency approval.•Updated labeling for LCM products resulting in completion of internal and external approved product labeling, including Corporate, US and EU labeling (IND & NDA).•Utilized Documentum (EDMS) computer system to maintain Corporate Regulatory Affairs documents. From October 2008 to March 2009 (6 months) Bridgewater, NJClinical Supplies Program Manager- Cardiovascular, CNS, Diabetes, Vaccines @ Merck •Independently monitored and coordinated activities associated with clinical supplies for designated studies within multiple therapeutic areas.•Authored the Clinical Supplies section of the study protocol. •Acted as a liaison with Clinical Research and Development and Project Management to identify and refine the clinical supplies requirements of each program and subsequently communicate these requirements to facilitate planning, prioritization, and execution of manufacturing and packaging. Represented Global Clinical Supply Operations (GCSO) on cross-functional teams as appropriate.•Utilized Microsoft Project to build Global Clinical Supply Operation project timelines to ensure key GCSO drug supply milestones were met by both GCSO and Clinical and CRO partners.•Provided demand estimates for clinical supplies into the ERP JDE system (electronic drug supply/ production system)•Reviewed and approved CSOPS Manufacturing and Packaging Requests generated by GCSO and Clinical.•Responsible for monitoring of Re-Evaluation Dates (REDs) as required and drug recalls •Responsible for monitoring re-supply trigger levels for Interactive Voice Response System (IVRS) studies and tracking study enrollment and discontinuation rates to adjust demand / supply needs.•Utilized EDMS and MIDAS computer systems to initiate, review, and update Clinical Operations documents such as; packaging specifications, protocol revisions, CSOPS, & RED’s. From July 2007 to October 2008 (1 year 4 months) West Point, PASenior Labeling Coordinator – Anti-Infectives, Cardiovascular, Psychiatry, Internal Med, Vaccines @ GSK •Represented GlaxoSmithKline as a Senior Labeling Coordinator in the US Regulatory Affairs department. •Served as authoritative source on laws and regulations pertaining to labeling development of GSK products. •Revised labeling documents as needed and proofread for accuracy, including the US prescribing information and medication guides (PILs), annual reports, amendments to pending applications and/or supplemental applications, safety reports, clinical summary documents, reference documents, and any ad hoc regulatory documents needed for submission to the Agency.•Chaired Labeling Review Committee meetings within GSK and between GSK and the FDA.•Provided creative approaches for developing product labeling while complying with FDA regulations and company policy, as requested.•Implemented new FDA Regulations for Physicians Labeling Reformat and Structured Product Labeling (XML) formatted documents.•Drafted revisions to the prescribing information for established Life Cycle Management products (both Microsoft and Epic Editor).•Negotiated resolution of complex issues.•Suggested labeling input at BRAND team meetings for the Division of Drug Marketing Advertising and Communications DDMAC review and copy approval for GSK marketed drugs. •Lead discussions on product labeling with multidisciplinary teams to gain consensus.•Updated regulatory database for GSK product labeling.•Supported development of launch materials/new claims by collaborating with Marketing, Medical and Legal. Prepared FDA submissions of draft introductory promotional materials.•Upon NDA approval, wrote the press release for the new product for and promotional use.•Brought three GSK investigational drugs to NDA approval with the FDA. •Achieved two GSK rewards for Service and Impact within the GSK organization.•Utilized Documentum (EDMS), AGILE, IMMS and Epic Editor Systems. From October 2004 to June 2007 (2 years 9 months) One Franklin Plaza, Philadelphia, PA

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In a nutshell

Denise Benedict's Personality Type

Extraversion (E), Intuition (N), Thinking (T), Judging (J)

Average Tenure

1 year(s), 7 month(s)

Denise Benedict's Willingness to Change Jobs



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