Regulatory Compliance Director

Nikki Messer

** *** ***** *****: 732-***-****

Ocean, NJ 07712 Email: *****.*****@*****.***

Dynamic and engaging professional with years of well-rounded experience. From solution implementation and integration/SOP writing/audits and Technical Support/warehouse team management -to Finance and asset management; experience in various functional areas has developed a strong understanding from a multi-faceted perspective. such oversight is invaluable within constantly evolving regulatory and technical environments.

Areas of Expertise

Identifying and providing solutions for process and/or procedural problems during corporate merger/compliance auditing/SAP/EDI integration as necessary.

ERP/SAP/EDI/EPCIS/State Licensing platform implementation, maintenance and continued IT support for team members in conjuncture with solution providers/

Provide supply chain support for distributors and collaborate with distributors and direct sales accounts to maximize customer satisfaction and reduce outstanding debts and collections. (CTC/ZB/Primed specific).

SOP development and writing/auditing along with training for employees from all functional areas.

Establish guidelines to minimize inventory losses, increase supply chain security, and increase warehouse efficiency.

Maintaining expertise on constantly evolving products and technologies.

Close coordination with corporate Operations, Sales and Marketing teams.

Assist with product training lead by the Director of Sales Training.

Notify sales force of any contract expirations or issues with sales compliance that may void repair terms or warranties.

SAP/repair procedure support for technicians and customer updates on repair shipments.

Maintaining expertise on constantly evolving products and technologies.

Professional Proficiencies

Seasoned professional with 14+ years of well-rounded Medical Device/Pharmaceutical experience.

Cross functional experience from Customer Service, Sales Support, Technical Support, Accounting/Finance and Operations Supervision experience.

DSCSA/cGMP/ISO expertise with SOP writing, analysis, and modification for continued QA and regulatory compliance.

QAA redline finalization, TVP{ (Transport Validation Protocol) approval on all inbound internation shipments from departure, CBP, and air/ground transportation.

BluLink/LSPedia/SAGE MAS 90-200/SAP/Verisys/Salesforce administrator in variety of integrative and implementation projects and daily maintenance of user and trading partners.

DEA/FDA & state specific reporting (ARCOS/CSOS/WDD&3PL,NDC Database)/Microsoft Excel for Financial and Compliance analysis/Microsoft PowerPoint for Operational Management reviews, EDI/EPCIS 1.1,1.2/GS1 implementation point person for DSCSA compliance regarding VRS/ASN 856/EPCIS-serialization, and all purchasing and sales EDI/EPCIS setup and maintenance.

Flexibility during corporate merger for compliance with new requirements, while providing strong support during procedural compliance/company culture/ and systems integration.

Professional Experience

NMM Consulting, LLC.- Independent Consultant

Remote/On-site, NJ/Multi State November 2023-Present

Initial writing, auditing, and ongoing Operations/DSCSA/State/21CFR compliance procedures for updated upcoming regulations.

All Master Data input, process implementation and integration into BlueLink/SAP for new Wholesaler/Contract Manufacturer, and onboarding of Master Data for serialization and EPCIS Provider integration, utilization and maintenance.

Physical warehouse design and layout for maximum efficiency. (CII-Non Controlled)

Wrote and trained employees on inventory control/count analysis/adjustments and valuation of asset discrepancies and depreciation.

Lead liaison for logistics, IT, EDI/EPCIS for drug product tracing requirements per DSCSA, and saleable return verifications (Both pre- and post VRS) implementation and analysis.

Armas Pharmaceuticals- Director of Regulatory Compliance-

Freehold, NJ April 2022- November 2023

Cross functional Operations/Regulatory Compliance lead. Ongoing DSCSA compliance procedures for updated upcoming regulations.

Lead New Product setup via DailyMeds, FDA NDC Website, and EPCIS provider databases.

New and existing inventory creation and maintenance in Cardinal Platform and forecasting facilitation, and physical warehouse counts.

Write/Audit SOPs, and train all employees to ensure Federal and state compliance.

Responsible for inventory complaints/control/count analysis/adjustments and valuation of asset discrepancies and depreciation. Ensure FIFO if not specifically requested dating.

Lead liaison for State Licensing/international (CBP) and interstate freight logistics, IT, EDI/EPCIS for drug product tracing requirements per DSCSA, and saleable return verifications (VRS) implementation and analysis.

Lead EPCIS compliance verification for all international inbound products coming from India, Switzerland, and Italy.

PM Project lead on all new internal initiatives from solution provider implementations to process upgrades.

Amazon Pharmacy/PillPack – Vendor Compliance Specialist/DSCSA SME

Remote, NJ June 2022-March 2023

Designed new Vendor Onboarding process, applications, integration into SalesForce, and provided 50% of the approvals outside of Sales/Purchasing teams requirement.

Wrote initial Vendor Compliance and DSCSA compliance standard operating procedures for updated upcoming regulations.

Implemented SOP compliance across multiple IMS/ERP/warehouse software.

Wrote SJI (Specific Job Instructions) for 4 separate IMS/ERP systems.

Wrote/Audited SOP and train all employees involved in purchasing, storing, packing, shipping producta to ensure Federal and state compliance per new DSCSA requirements as well as grandfathered T3 EDI and paper transactions for all inventory, sales, and return transactions to ensure federal/state/PBM compliance.

Responsible to store and audit all T3 document receipts for 11 warehouses prior to EPCIS and scanning functions.

Responsible for identifying, justifying, and alerting leadership of bad actors and grey market activities from existing and new vendors.

PriMed Pharmaceuticals- Director of Regulatory Compliance

Eatontown, NJ February2017-June 2022

Cross functional Operations/Regulatory Compliance lead. Ongoing DSCSA compliance procedures for updated upcoming regulations.

All Master Data and scanning for serialization and EPCIS implementation and maintenance.

Inventory maintenance in ERP system and forecasting facilitation based on sales analysis, market supply changes, and physical warehouse counts.

Write/Audit SOPs, and train all employees to ensure Federal and state compliance.

Responsible for inventory control/count analysis/adjustments and valuation of asset discrepancies and depreciation.

Lead liaison for logistics, IT, EDI/EPCIS for drug product tracing requirements per DSCSA, and saleable return verifications (VRS) implementation and analysis.

Lead T3 compliance verification for all financial and sales related transactions.

Successful submission and completion of FDA Pilot Project for VRS on behalf of market sector. Only secondary wholesaler, outside of the Big-3 or specialty distributors, involved in FDA Pilot.

PM Project lead on all new internal initiatives from solution provider implementations to process upgrades

Nationwide Laboratories, LLC/BiCoastal Pharma, LLC- Quality Assurance Director

Iselin and Shrewsbury, NJ (Contracted) 2019-2020

Ensuring that the various operations associated with all Quality and Control systems are appropriately planned, approved, conducted and monitored.

Ensuring that controls are implemented and completed satisfactorily during Own Label manufacturing operations.

Ongoing compliance monitoring to ensure compliance with cGMP and DSCSA (serialization/VRS/EPCIS/Master Data).

Approving and rejecting incoming materials, in-process materials and drug products. Reviewing production/batch records and investigating any unexplained discrepancies.

Responsible for all ADE reporting and analysis, per FDA requirements for Own Label Manufacturers.

Zimmer Biomet- Operations Supervisor/Technical Support/Accountant

Eatontown, NJ 2016-2017

Cross functional Operations/Product repair liaison and customer/vendor account management.

SAP maintenance supervisor for technical support and repair/product related issues in accordance with corporate regulatory compliance. All products FDA/ISO regulated and monitored by QA and post market team. Data for analysis generated through SAP system and reported directly to Operations Manager.

Train and assist Technical Support team and Sales Representatives for device operation, repair related issues and warranty terms.

A/R, A/P, COGs, inventory valuation and capital asset depreciation. Monthly accruals and G/L adjustments. MedSurg dealer liaison for logistics, EDI, rebate and fee negotiation. GAAP compliance in all financial and sales related transactions.

Compression Therapy Concepts- Logistics and Supply Chain support/Technical Support/Accountant

Eatontown, NJ 2011-2016

Medical device technical support for on-site biomed departments and materials management. Analysis of repair trends. All administrative repair related work orders and maintenance.

Customer and MedSurg dealer support with logistics, product discrepancies and product complaints. Sales Rep support and training on product usage and repairs.

All A/R procedures from invoicing, deposits, cash entry, collections, contract pricing and compliance. G/L entries and monthly accruals for basic inventory and cost accounting purposes.

Education/Accomplishments & Training

Pharmaceutical and Medical Device Compliance Law Certificate 2018-2019

Seton Hall Law-South Orange, NJ

Bachelors of Science, Biological Sciences/Psychology 2010

Rutgers, The State University of New Jersey- New Brunswick, NJ

Designated Representative for PriMed Pharmaceuticals successful NABP Drug Distributor (FKA VAWD) Accreditation

The GS1 Standards: Drug Supply Chain Security Act (DSCSA) Online Certificate Course

SAP for QA and Regulatory reporting training

FDA and ISO Certification and Compliance

Corporate Finance Compliance/GAAP

HCP/Vendor/Customer Vetting and Compliance SME

Zimmer Biomet Merit Award Recipient July 2017

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