SKILLS:

Pharmaceuticals; Pharmacovigilance; Regulatory Affairs; Clinical; Quality Assurance; FDA; GMP; GCP; Data Management; Lotus Notes; Isotrain; eDOCs; E2B; Validation; Process Improvement; Outlook; Windows; Microsoft Office; Word; MS Sharepoint; SOP; Excel; Administration; Visio; PowerPoint; Change Management; Mergers; Supervisory; Knowledge of Confidential /ICH/Volume 9A/ Global regulations and guidelines; Proficient with ARISg / AEGIS / Oracle AERs database; ARGUS; Pilgrim Software/Smart Solve; Soltraq TrackWise; Adobe; Citrix; IRIS; SAP; Windchill PLM system (US tech files); Agile PLMPROD (EU tech file database) Adaptiv (Manufacturing Changes, Change Assessments, Change Orders); PLM; Creo; EOS (Workflow Management & Digital Asset Library); DocuSphere; CDR

PROFESSIONAL EXPERIENCE:

Confidential, West Chester, PA

REGULATORY SPECIALIST

Responsibilities:

• Work with Standards fulfillment: LoAS (List of Applied Standards), GSPRC (Global Safety and Performance Requirements Checklist).
• Create LoAS: Harmonised Standards Applied and non - Harmonised and other e.g.ASTM. Responsibility: Ensure all applied standards listed.
• Create Technical Documentation Report (TDR) (formerly Technical File Summary Report, TFSR) through the Agile system.
• Declaration of Conformity with full Quality System.
• Working with procedures that are applicable to current European Legislation, MDD (Medical Device Directive) 93/42/EEC and the MDR Regulation 2017/745.
• Working with technical documentation requirements that are defined in Annex II of MDR.
• Review and implement the inclusion of EU Regulation 2017/745MDR requirements for IFUs (Instructions for Use): Patient Target Group, Intended User, Clinical Benefits, Performance Characteristics of the Device, Side Effects changed to Potential Adverse Events, and Implant Removal.
• Create product-specific IFU in place of a family IFU using template.
• Complete LCR (Labeling Consistency Review) for customer facing document. Compare and combine information from Surgical Technique Guides and Insert/IFU.
• Complete a Labeling Consistency Assessment.
• Review and approve External Risk Management Scope List. List of Analyzed Parts for DCRM (Design and Clinical Risk Management).
• Review SEV (Standard Evaluation / Standard Evaluation Rationale.
• Review UEF (Usability Engineering File).
• Review DCRM.
• Collaborates with Medical Affairs, Engineering, Clinical, Biostatistics, and others to ensure evidence needs and gaps are understood, reviewed and implemented in documentation.
• Perform Active License Searches for Health Canada.
• Utilize Confidential website and retrieve Confidential Clearance Letters for products.
• Scan and upload 510(k)s and CERs (Clinical Evaluation Reports) in BOX and Shared Drive.
• Review and Approve changes that affect a medical device or regulated product. List of processes: Changes in Agile, ADAPTIV, changes to labeling that provides instructions for use (surgical technique guides, patient care guides, etc., review supplier changes in SAP, Manufacturing changes requiring regulatory review and approval, and Production and/or Process Transfer.
• Assesses the regulatory impact of changes in the United States and the European Union (EU).
• Communicates the regulatory impact assessment to change stakeholders.
• Documents the regulatory impact and actions required to support changes in all countries including those assessed by RALI (impact changes in Canada and all ROW countries).
• Ensures necessary controls and/or regulatory actions for regulatory compliance are completed prior to approving a change.
• Review non-conformance observation and create Excel spreadsheet for an Assessment Report capturing the observation details and objective evidence.
• Review and capture IFU (Instructions For Use) documentation discrepancies with 510(k) indications, the Confidential Clearance Letter, and the IFU). Redlined IFUs.
• Created Note-to-File for a regulatory strategy assessment on Synthes Reprocessed External Fixation Devices that are intended for single use only but may be reprocessed up to two times by Synthes (for a total of three uses) as cleared in K033158 and K161417. The purpose of the regulatory strategy was to document the addition of Confidential

Confidential, West Chester, PA

REGULATORY SPECIALIST

Responsibilities:

• Project team CMF (Craniomaxillofacial)/Trauma with conversion of pending Document Control Risk Management (US only) to Global.
• Review and approval for Global Risk Management.
• Review and Create Red-lines for the US-EU Surgical Technical Guides (STG).
• Support CAPA.
• Harmonize between the EU and US in the STG and Indications for Use (IFU).
• Update branding and formatting according to Confidential Synthes Branding requirements.
• Support Project Phoenix when appropriate.
• Update Indications for Use (IFU) to include the updated STG website reference in the Warnings and Precautions sections. Support minor branding for the updates.
• Compared US red-lines in STG to Label Control Record (LCR) as well as the Document Control Risk Management (DCRM) in Windchill.
• Interface with Document Quality Engineers (DQEs), Labeling Team, and Product Development Engineers (PDEs).
• Approve and sign off STGs in ZincMaps.
• Represents Regulatory Affairs on Class I and Class II Tech File Remediation Projects.
• Perform S&C (Sales and Complaints) analysis for the timeframe of 3 years (minimum) for articles within scope of DCRM (Design and Clinical Risk Management).
• Evaluate performance and safety from S&C.
• Serves as a consultant in preparation of the DCRM.
• Identify highest risks associated with the parts in scope from DCRM.
• Ensure that Contraindications, Device Specific Adverse Events, Warnings and Precautions are aligned between the DCRM, CER (Clinical Evaluation Report) and labeling documentation (IFU-Instructions for Use, STG -Surgical Technical Guide and Patient Care Guide).
• Ensure that the DCRM addresses MRI / Lifetime / Debris & Removability requirements.
• Provide the input on the clinical section of the DCRM.
• Approves DCRM once the document is finalized.
• Review RMR (Risk Management Report) for highest risks from the DCRM are included and aligned in terms of the assigned severity of harm.
• Review appropriate / applicable documents that are referenced in RMR.
• Approves RMR.
• Review blueprint drawings for material, ASTM(s) (American Society for Testing Materials), ISO(s) (International Organization for Standardisation).
• Review EPL(s) External Parts Lists in SharePoint and approve in Windchill.
• Provides input on CER as part of the cross-functional team.
• Ensures the following points are addressed in the CER: MRI, Lifetime, Debris & Removability requirements, Bio-compatibility / Biologic Safety Evaluation, and Sterility.
• Review TF SEV (Standard Evaluation) to for Class I (or IIa instruments) using EN ISO 16061:2009.
• Consulted during creation of the Mechanical Testing Summary and Memos to ensure that an understanding of the entire scope of the mechanical testing and clearly identify that testing was performed on the worst-case parts where applicable.
• Compiles the Harmonized Standards in the LoAS (List of Applied Standard) in Agile and ensure they align with the ERC (Essential Requirements Checklist).
• Collaborates with the SEV team to list all applied general standards identified in the TechFile documentation (eg standards listed in DFP (Decision Finding Protocol) and other V/V (Verification / Validation) documents.
• Ensures that No Harmonized Standards are erroneously listed in the General Standards table.

Confidential, Racine, WI

Responsibilities:

• Creates and maintains formula recipes, or Finished Good (FG) recipes in the Product Life Cycle Management (PLM) System in support of New Product Development (NPD) and brand maintenance.
• Responsible for the coordination of object approvals across many company disciplines including RDE, Global Safety and Regulatory Affairs (GSARA), Product Supply and Marketing.
• Ability to work independently and demonstrate thought leadership with data integrity, audits, and assessments.
• Demonstrates initiative, detail-oriented and highly organized with data remediation and analysis.
• PLM and/or SAP experience especially in creating and maintaining formula recipes.

Confidential, Waukegan, IL

Regulatory Affairs Specialist

Responsibilities:

• Tracks registration activities and status to deliver on-demand reports that meet internal business needs and regulatory authority requirements.
• Communicate with affiliates in order to track submissions and the submission status.
• Utilizes SharePoint platform (Team Sites and portals).
• Manages and processes data Excel Spreadsheets.
• Maintains Registration program records for US registered products in IRIS
• Maintains US country records for each registration program in IRIS
• Change control documents. Analyze red-lined documents, implement changes, and re-route to execute level for approvals.
• Create SIs (Status Information Reports).
• Perform Withdrawal - No Renewal on product registrations. Create a Withdrawal Submission Record. Set Country Registration on Closed-Inactive.
• Perform Voluntary Withdrawal. In general V1 (Voluntary withdrawal of Marketing Authorization Application by company) means the product has never been registered and will be withdrawn; V2 (Voluntary withdrawal of approved Marketing Authorization Application by company) means the product is registered but will be withdrawn.
• Close Country Registration and Submissions if a product was not registered.
• Create a Submission Planning Record for a product in several countries.
• Perform Request for Information (RFI), former Deficiency Letter Handling.
• Perform electronic Initial Submissions.
• Perform electronic Submission - Variation.
• Key regional support for Latin America in regards to MTR, Initial, Variations, Renewals, and Commitments.
• Support to Middle East/Africa, APAC/India, CIS/Russia/Europe, Mylan Support in regards to MTR, Initial, Variations, Renewals, and Commitments.

Confidential, Waltham, MA

SENIOR POST MARKETING SURVEILLANCE

Responsibilities:

• Ensures complaints are processed in a uniform and timely manner, whether they are equipment, drug or device origin.
• Responsible for receiving, reviewing, entering, evaluating data into the Complaint Management Database (Pilgrim) regarding customer/patient product inquiries and complaints.
• Interfaces with Customer Service and customer/patients to gather additional information required for complaint investigations, including the retrieval of product samples.
• Applies knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE reporting decision process within regulatory timeframes.
• Can process MDR/ADE decision trees and is able to complete MDR submissions.
• Provides coding support and reviews. Updates complaints in the Pilgrim.
• Assigns complaint class based on the Master Symptom Code Severity List.
• Prepares customer communications (response letters, acknowledgement letters) as appropriate.
• Partners with sales, marketing and manufacturing departments to resolve product problems and provides feedback to customers as needed.
• Responsible for maintain complaint files within a secured environment.
• Ensures complaint responses and any reply to the complainant is documented in the complaint file when applicable.
• Performs queries to provide complaint data.
• Interfaces with Corporate Quality Engineering and the RTG manufacturing sites as required for product investigations and trend reporting.
• Assists with department CAPA duties as assigned.
• MDR/ADE submission reportable malfunctions/serious injuries and post medical record review and system level MDR/ADE submissions.
• MDR/ADE pre-submission reviewer.
• Assist management with work flow specialist’s assignments.
• Complaints file closure. Ensures the timely closure of all complaint files in a consistent and timely manner. Ensures that all pertinent information is contained within the file prior to closure. Monitors and reports on complaint closure as required.

Confidential, Waukegan, IL

CLINICAL MEDICAL SERVICES SPECIALIST

Responsibilities:

• Performs uniform and timely documentation and processing of complaints.
• Documentation of all complaints upon receipt / customer contact
• Identification of adverse events and potentially reportable events (pRE)
• Documentation of complaint resolution when resolution can be identified and
• Any response to the complainant
• Criteria for classification of customer contact, field service contacts representing customer complaints versus routine service or demand service or non-complaints, if applicable.
• Assessment of field service contacts to identify pREs and assure elevation of field service contacts to complaints.
• Criteria for initiating complaint investigations, including criteria needed to trigger a CAPA input that is associated with a complaint or complaint trend.
• Documented justification for when no investigation is necessary, including the name of the person(s) responsible for making that determination.
• A complaint that has been reported to a regulatory agency as a Confidential Regulatory Report (FAR) or Medical Device Report (MDR) must have a complaint investigation or reference to a nonconformity report.
• Assessment of risk.
• Ensure proper classification of quality issues within the Product Complaint Analysis (PCA) or Soltraq TrackWise system in order to expedite the processing and closing of complaints while maintaining compliance.
• A repository for complaint records including accessibility to the manufacturing site.
• Tracking and trending of complaints, adverse events, field service records and procedures for responding to trends including the possibility of recalling product.
• Complaint data for management review.

Confidential, Deerfield, IL

PV COORDINATOR

Responsibilities:

• Collect, assess, and process all domestic and foreign adverse events for Clinical and Post-marketed products in accordance with company SOPs and ensure compliance with Confidential and global regulations/guidelines.
• Prioritize all incoming serious and non-serious adverse events, adhering to department SOPs.
• Responsible for managing/processing all incoming adverse events.
• Proficient with ARISg Global database.
• Manage adverse event reports from initial case receipt through case completion.
• Utilizes SharePoint platform (Team Sites and portals).
• Manages and processes data Excel Spreadsheets.

Confidential, Deerfield, IL

SENIOR DATA ASSOCIATE

Responsibilities:

• Collect, assess, and process all domestic and foreign adverse events for Clinical and Post-marketed products in accordance with company SOPs and ensure compliance with Confidential and global regulations/guidelines.
• Prioritize all incoming serious and non-serious adverse events, adhering to department SOPs.
• Responsible for managing/processing all incoming adverse events as well as product complaints.
• Proficient with Oracle AERs database and ARISg Global database which is SAP Certified, powered by SAP NetWeaver.
• Maintain current knowledge of company products through active participation in the processing of medical information, product complaints, adverse event processing/reporting, and Global Pharmacovigilance meetings.
• Assist in the preparation of NDA Safety Updates, IND Safety Reports, Product Labeling/Package Inserts and other reports as necessary.
• Ensures Product Complaints related to product quality issues are handled in a timely manner.
• Act as liaison between the Quality Department, Medical Affairs, Confidential in New Jersey (the manufacturing plant), our Partners, and the Clinical Department for adverse event reporting and product complaints.
• Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information and indications.
• Communication with written Customer Response Letters in regards to product complaints to complainants or business partners.
• Responsible for training of Data Coordinators (new and/or contractors) on the Oracle AERS database and the ARISg Global database as well as data entry processes.
• Manage adverse event reports from initial case receipt through case completion.
• Prepare expedited adverse events reports and periodic safety update reports for Regulatory submission.
• Assist in overseeing the consistency of data collection and entry processes during the day-to-day operations.
• Review and analyze all data entry to ensure accuracy, efficiency and make recommendations for changes and/or improvements.
• Review and analyze narratives and/or MedWatch Confidential Form 3500A, generate queries, and ensure all serious adverse event reports for clinical studies are handled in a timely manner.
• Interface with medical reviewers on adverse events and other safety related issues.
• Assist with the reconciliation of safety reports (e.g. Periodics, PSURs, etc.).
• Ensure all literature searches are performed accurately and entered into Reference Manager.
• Responsible for performing a quality check on all serious and non-serious cases.
• Maintain accurate files and documentation based on Good Documentation Standards.
• Maintains communication with Confidential Inc. ’s global affiliates to ensure prompt notifications of safety issues.
• Ensures compliance with EU and/or Confidential regulations according to ICH guidelines, national regulation guidelines and SOPs, with an emphasis on those governing safety reporting.
• Participate in project team meetings and Safety related meetings.
• Assist in developing and maintaining policies and SOPs in accordance with regulatory guidelines.
• Contribute to Global Pharmacovigilance projects as appropriate.
• Responsible for sending accurate notification reports to business partners, domestic and internationally.
• Collaborated on a merger/acquisition team with colleagues from different department levels to integrate documents and processes.
• Change management with IT processes and processes within the department.

Confidential, Deerfield, IL

SAFETY DATA COORDINATOR

Responsibilities:

• Perform data entry of adverse events for clinical and post-marketing products; includes, but is not limited to login, tracking, data entry, editing, and source verification, generation of new and standardized documents.
• Assist with preparation of safety reports (i.e. Periodics, PSURs, etc); interface with safety writing and report groups.
• Perform standard safety database queries.
• Good working knowledge of and expertise in using safety database.
• Interface with safety and medical reviewers on adverse events and other safety-related issues.
• Assist with call-center activities related to adverse event reporting.
• Interface with other Baxter groups as needed (i.e. Quality, Regulatory, Informatics, Business units, etc.).
• Make recommendations to improve the efficiency and effectiveness of the data coordinator group performance.
• Additional responsibilities and projects as assigned.
• Proficient with the Oracle AERs database.