Chemical Engineering Regulatory Affairs

MARY L. DUMAS 732-***-**** **********@*****.*** Belle Mead, NJ

Experienced Pharmaceutical Professional

Collaborative, problem solver with an ability to lead a team of professionals, seeking a Director role in Healthcare or Pharmaceutical industries.

TAKEDA BELLE MEAD, NJ

ASSOCIATE DIRECTOR, PV BUSINESS PARTNER RELATIONS

2022

● Led Streamline PVA Review Project

Coordinated with 9 reviewers while consistently updating the cross functional distribution chart Achieved a 78% reduction in Required Reviewers for PV Agreement negotiations Trained key stakeholders and Contract Research Organization on new process and updated relevant SOPs

● Communicates daily with multiple stakeholders to help improve PVA process efficiencies and ensure compliance

● Created Clinical Supply Pharmacovigilance Agreement template to address use of Takeda compounds in Clinical Studies by Partner Sponsors

● Evaluated Vendor Oversight Invoice payment process for cost savings and efficiencies. Business Owner(s) invoice approval process and automatic invoice payment to generate discounts were reviewed.

● Initiated Cross Training Series for Alliance Management team. Recorded training sessions, created a training repository with essential documents and a 6- month training schedule for future speakers. NOVARTIS EAST HANOVER, NJ

MANAGER, DRUG REGULATORY AFFAIRS

2017 - 2021

● Provided regulatory advice to commercial teams, payment, internal training teams on promotional & disease awareness materials

● Ensured on-time submission of 2253 documents to the FDA by working closely with Regulatory Operations

● Developed promotional and non-promotional materials for external use for 2 solid tumor franchise products

● Reviewed internal communications intended for training, education, and learning and development ● Provided critical regulatory review of external communications placed on various digital social media platforms including Facebook, Instagram and YouTube

● Collaborated with legal, commercial brand teams, medical information and digital to ensure our promotional materials complied with the Office of Prescription Drug Promotion (OPDP) guidelines. Promotional materials CMK

● Consultant providing services to Novartis. Responsible for managing all contract requests from US HE&OR, the Digital Innovation team and Field Medical on behalf of US Clinical Development and Medical Affairs ● Led contract negotiations with External Service Providers and Academic Research Organizations to ensure timely, quality, risk averse and cost-effective projects

● Proactively conducted quarterly touch base meetings with internal stakeholders

● Led cross-functional collaboration to create contracts for Digital Innovation projects to obtain necessary approvals and ensure compliance with internal SOPs and Federal Regulations (e.g.Sunshine Act, Publications)

● Worked closely with the functional lead, legal, and finance to resolve any contract issues and obtain necessary approvals

● Familiar with GSAs, MSAs, SSAs, CTAs, Authorship, Consulting and Sponsorship Agreements ● Successfully executed a contract with a challenging Partner after years of unsuccessful attempts. Business relationship has been reactivated and completely engaged. 2

● Negotiated contract fees in the amount of several hundred thousand to over $1MM MARY L. DUMAS 732-***-**** **********@*****.*** Belle Mead, NJ OTSUKA PHARMACEUTICAL PRINCETON, NJ

DIRECTOR, GLOBAL PV ALLIANCE

2014 – 2016

● Managed 14 person global team during the Pharmacovigilance Revision Project. Constant review of Global regulatory requirements regarding drug safety.

● Orchestrated project resources, key stakeholders, maintained progress and time frames for completion of the Pharmacovigilance Agreements (PVA) Revision Project to align current safety contracts with the new PVA template globally

120 PVAs and Distribution & Supply agreements were evaluated and analyzed 30 active agreements were placed on the new PVA template (vs. 15 PVAs from 2015)

● Collaborated effectively with PV functional team leads, clinical teams, alliance partners, CROs and regional legal departments to resolve complex issues and achieve compliance with regard to regulatory reporting worldwide

● Co-chaired the PV Regulatory Reporting team meetings

● Created systems and processes to manage drafting, negotiating and archiving of agreements to ensure quality compliance and increase efficiencies

97% quality control achieved

50% reduction in review time

● Established monthly dashboards to provide updates to executive leadership team on all PVAs and Safety Management Plans

● Presented at 2015 BfArM inspection in Germany

BRISTOL MYERS SQUIBB PRINCETON, NJ

CONTRACTS MANAGER

2011 – 2014

● Responsible for all clinical trial agreements supporting the Oncology, Hematology, Cardiovascular, Neuroscience and Immunology teams

● Implemented and designed a new SharePoint site to capture quality related events for BMS promotional materials with the US Pharmaceutical Compliance team

● Finalized CAPA report regarding an investigation and effectively communicated a high level TRAX process to the team

● Launched a new contract request system using InfoPath to improve transparency and monitor contract and invoice processing to decrease cycle time

● Negotiated, executed and monitored payments on Consultant Agreements and Statements of Work for Advisory Boards, Data Monitoring Committees, Study Steering Committees,Adjudication Committees, Investigator Initiated Trials (IIT) and Patient Advocacy Groups for Health Care Providers and Non-Health Care Providers

● Collaborated with Resource/Grant Managers, Protocol Managers, Medical Directors, Operation Leads, Regulatory and Patent attorneys

● Managed the Sunshine Act Reporting team to ensure accurate reporting and compliance

● Instrumental in “Voice of the Patient” project with Patient Advocacy group

● Knowledgeable in FDA and International Drug Safety regulations, Foreign Corrupt Trade Practices Act, Anti Kickback Statute and Sunshine Act

3

MARY L. DUMAS 732-***-**** **********@*****.*** Belle Mead, NJ FOREST RESEARCH INSTITUTE JERSEY CITY, NJ

CONTRACTS MANAGER, GLOBAL DRUG SAFETY

2009 – 2010

● Responsible for all safety related agreements within Global Drug Safety and collaborating with internal and external stakeholders and alliance partners

● Drafted and Negotiated Safety Data Exchange Agreements (i.e., PVAs) with various international business partners to facilitate data exchange procedures and timetables for clinical trials and post marketed drugs ● Supported the Neuroscience, Diabetes and Dermatology teams by drafting amendments to PVAs, Licensing Agreements, Safety Plans and Safety Medical Monitoring Plans

● Developed a template for WW Regulatory Reporting of individual case safety reports (ICSRs) and aggregate reports from clinical trials to the FDA and other health authorities

● Cross divisional collaborations with medical, regulatory, drug safety operations, clinical, legal and CROs JOHNSON & JOHNSON HEALTHCARE SYSTEMS PISCATAWAY, NJ CONTRACTS MANAGER

2008 - 2009

● Drafted various agreements to support the commercial teams and legal for the Cardiovascular, Consumer Products businesses and other operating companies. AFFILIATIONS

Women of Color in Pharma

Toastmasters Organization 2013 - Present

Sponsored Lunch & Learn on Importance of Mentorship with Career Networking Group Power UP Teen Summit organizer 2018

EDUCATION

eCornell Certificate

The Psychology of Leadership, December 2022

Lucy Rose & Associates

FDA, Office of Prescription Drug Promotions Certificate (Drug Regulatory Affairs), December 2019 Temple University Beasley School of Law, Philadelphia, PA Obtained Juris Doctorate degree with a concentration in Property law and Intellectual Property Temple University Beasley School of Law, Philadelphia, PA Compliance Certificate, 2016

Howard University, Washington, DC

Obtained a Bachelor of Science in Chemical Engineering

Contact this candidate