Francesca Gould - Regulatory Program Manager,

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Work Background

Hologic, Inc.Regulatory Program Manager

May. 2023Remote

PhilipsSr. Regulatory Program Manager

Aug. 2022 - May. 2023United States

PhilipsRegulatory Program Manager

Aug. 2021 - Aug. 2022Home-based in Cincinnati, OHResponsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy. Responsible for overseeing product registrations/approvals for international markets for our Connected Care business cluster. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and in maintaining regulatory compliance. Advises product design teams on regulatory strategy and requirements for specific new products/solutions. Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking, product registrations, and clinical evaluations. Utilizes wide-ranging experience, using professional concepts and company objectives, to resolve complex issues in creative and effective ways. Expert level knowledge of company products and services and tasked with introducing new concepts. Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.

PhilipsEU MDR Project Manager

Oct. 2018 - Aug. 2021Home-Based in Cincinnati, OhioArchitect and implement the core EU MDR/IVDR Program Management Office (PMO) planning activities to achieve timely EU MDR/IVDR milestone completion and overall compliance with the new regulation by May 2020 and May 2022. Support the EU MDR/IVDR Program Management Organization (PMO) leader, defining process improvements, change management, ways of working & interfaces with businesses and other functions developing timelines, deliverables and ensuring there will not be fundamental strategic and operational disconnects between the cross enterprise framework and business entities (including pre-market, supply chain/operations, post market and IT functions). Improve & execute strong operating mechanisms/performance monitoring reviews to establish reporting which include timely communication with PMO, business leadership and stakeholders. Audit program/project documentation to track progress and escalate information appropriately as well as develop and complete analytics of Key Performance Indicators (KPI). Help identify key priorities and decisions to enable the organization to capture key opportunities to reduce risk and improve performance. Design & implement central project management tools/templates (SharePoint, trackers, etc), support lessons learned driving consistency and alignment across business, workstreams and taskforces with peers. Leverage well developed interpersonal skills to build and maintain positive working relationships with functional groups throughout the organization. Provide guidance and coaching/mentoring to team members and other project leaders as appropriate.

Ethicon, Inc.Life Cycle Management Regulatory Affairs Project Manager II

Oct. 2017 - Oct. 2018Cincinnati Area, KYContract assignment through Pioneer Data Systems, Inc. Support regulatory affairs activities for various medical device Life Cycle Management (LCM) projects. Maintain working knowledge of US, EU and International regulations to sustain compliance with worldwide regulatory requirements. Gather information across the life of a product in order to make appropriate, timely and strategic decisions. Generate regulatory strategies and gain a competitive advantage for obtaining regulatory approvals. Support the preparation, review and submission of dossiers to global health authorities for product or process changes such as marketing authorization renewal, modifications, and product line extensions, where needed. Leverage process efficiency and technology to drive new levels of operational excellence.

MedpaceSr. Regulatory Submissions Coordinator

Jul. 2016 - Oct. 2017Cincinnati, OHTeam lead and acting submissions manager. Efficiently manage and successfully execute all aspects of US and Canada study start-up. Assemble, review and perform quality checks on start-up submission documents and site essential documents. Prepare and approve informed consent forms (ICFs). Develop and maintain timelines for submissions and site start-up. Review pertinent regulations and guidances to develop proactive solutions to submissions issues and challenges. Provide insightful input on process, templates, eTMF contents, etc. Provide leadership and guidance to other Regulatory Submissions Coordinators as well as Clinical Research Associates (CRAs). Provide day-to-day departmental as well as project team support. Competent authority and IRB/IEC/REB/IBC submissions.

MedpaceRegulatory Affairs Associate II

Nov. 2015 - Jul. 2016Cincinnati, OHTeam lead and acting regulatory project manager. Oversee the process of preparing product submissions to domestic and international regulatory bodies, from inception to approval. Submissions to as well as management of relationships with the Food & Drug Administration (FDA) and the Recombinant DNA Advisory Committee (RAC). Plan, review and approve required documents from various departments for inclusion in submissions. Oversee the writing, publishing, and correct placement in eCTD hierarchy. Collaborate with EU regulatory to develop global approval strategies. Develop and manage project deliverables/timelines. Review pertinent regulations and guidances to develop proactive solutions to submissions issues and challenges. Orphan drug, fast-track, pre-IND, new INDs, updates to IND, and original/supplemental NDA filings.

Cincinnati Children's Hospital Medical CenterRegulatory Affairs Specialist

Jan. 2013 - Nov. 2015Cincinnati Area, KYTeam lead. Day-to-day oversight of the Bone Marrow Transplant and Immune Deficiency department’s regulatory affairs and submissions activities. Preparation and submission of investigator-initiated and industry-sponsored research protocols, ICFs and corresponding documents required by various regulatory agencies, such as the FDA, local Institutional Review Board (IRB), RAC, and local Institutional Biosafety Committee (IBC). Prepare, plan and participate in all monitor visits, regulatory audits, and internal quality reviews. Develop/maintain the necessary infrastructure and operational systems to increase and sustain high levels of research productivity. Ensure submission of application for renewal of federal grants. Assist in preparation and review of research proposals and grant submissions, as needed. Present educational programs for investigators, research coordinators and other groups. Abstracts Gould, F. (2013, November): Managing Genomic Findings of Pediatric Clinical Research Studies Challenges, Ethical Considerations and Best Practices. Selected as an oral and poster presenter at the PRIM&R Advancing Ethical Research (AER) Conference in Boston, MA.

INC ResearchClinical Data Associate II

Dec. 2007 - May. 2012Cincinnati Area, KYTeam lead. Oversee and perform all data management tasks, as appropriate. Data review and query management to ensure that quality standards are achieved. Reconciliation of the clinical database against safety data, laboratory data and other third-party data. Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data. Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database as required. Create, review, and/or execute Case Report Form (CRF) and Edit Check Specification User Acceptance Testing by creating/reviewing dummy data to evaluate Electronic Data Capture (EDC) database functionality. Assure compliance with protocols and assist with audits by regulatory or funding agencies. Kendle International was acquired by INC Research in 7/2011.

Kendle InternationalIn-House CRA

Nov. 2005 - Dec. 2007Cincinnati Area, KYThree week temporary/contract assignment through Kelly Services turned into full-time employment as of 04/2006. Team lead. Support clinical project team by updating and maintaining clinical systems that track site compliance and performance within project timelines. Develop and maintain Trial Master Files (TMFs) for multiple studies. Conduct periodic review of study files for accuracy and completeness. Plan and execute project training session(s) for Investigator Meetings (IMs). Coordinate selection of Principal Investigators (PIs) and clinical research sites. Assist sites with IRB submissions and oversee site compliance with federal regulations, ICH GCP, and state/local laws. Centralized monitoring and clinical study data processing. Identification and escalation of out-of-scope activities. Provide guidance on development of study materials such as patient brochures, patient recruitment materials, manual of operations (MOP), and newsletters, as required.