Confidential, Parsippany, NJ
REGULATORY AFFAIRS SPECIALIST
- Received award for cost saving, and recognition for organization of PRC, and contribution to success of publishing efforts at inception of electronic submission process
- Two primary focus areas: Promotional Review Committee and Document Management for submissions to US FDA & Health Canada (HC)
- Submitted 15 - day Adverse Drug Event (ADE) Reports to HC and FDA and maintained ADE submission Excel tracking logs and hard copy files. Audited records as requested.
- Reviewed promotional labeling for compliance with FDA guidance.
- Managed submissions and associated activities such as planning, document preparation for publishing, quality check reviews, transmittal to Health Authorities, tracking, records management (archiving, retrieving documentation) and product lifecycle for all products.
- Responsible for management, tracking, document preparation (bookmarking, hyperlinking, ready for submission PDF formatting in Adobe Pro, check sum) compilation, coordination, review, publishing and submission of various types of submissions to US and Canadian regulatory authorities including ADN (HC), and US FDA: NDA/BLA Annual Reports, Amendments. Supplements, Periodic Safety Update Reports (PSUR), PAS, DMF amendment, CBE, IND and Statement of Investigator
- Preparation of documents for paper, hybrid, electronic CTD/eCTD submissions using MS Word, Adobe Pro, SharePoint & Check Sum Verifier
- FDA 356h, 2252, 2253, 1571, 1572 and HC Post-NOC Changes,
- Liaised with Regulatory Associates, Medical Writers and Publishers, as necessary, to coordinate submission timelines, document delivery, technical specifications, final submission review and regulatory agency delivery confirmation.
- Assisted Regulatory Affairs team members, Medical Writers and other authors/SMEs with document authoring requirements, formatting, resolving document issues and ensuring submission ready documentation.
- Collaborated on the development, review and update of Regulatory Department's procedures associated with submission and document/records management.
- Records Management responsibilities included receiving, filing, maintaining, tracking and managing the lifecycle of essential documentation/information transmitted, providing archivist with archive copy.
- Logged and Tracked regulatory submission activity in STARS (TrackWise EQMS) query and reporting, VeevaVault eDMS CMS, Excel
- Assisted in the implementation and maintenance of document/records management tools for secure and efficient access to essential documentation. Such tools include, but are not limited to eDMS platforms, Veeva Vault, printers, supplies, archiving locations, validation and viewer software. Additionally, maintains Confidential searchable repository for legacy documentation.
- Promotional Review Committee (PRC)-coordinated and scheduled marketing and vendor inputs of review materials, facilitated PRC meetings (WebEx, LYNC and live), and annotated documents. Post PRC QC review and approval of final pieces and 2253 submission to US FDA OPDP. Tracking and monitoring submissions for compliance. Archiving file copy.
- Completed ad-hoc assignments from manager or team members, including, but not limited to, retrieving documentation, training new or existing team members on new processes or job related tools and participated on project teams that are relevant to Regulatory functional expertise.
Confidential, Allentown, PA
REGISTERED NURSE BEHAVIORAL HEALTH
- Psychiatric nursing care of patients on the adult and adolescent inpatient BH units.
- Health promotion and intervention for inpatient adults/adolescents with mental illness and related disorders
ConfidentialPHYSICIAN SOFTWARE EDUCATOR
- Technical Trainer responsible for primary training of physicians, clinical and office users on various Electronic Health Record EMR EHR systems. Blended, WebEx, classroom, lecture, support for implementation and emergent issues
- Instructional design and eLearning authoring and LMS, workflow analysis, customized for multiple therapeutic areas.
- Lead Educator management of training projects collaborated with analysts in data validation, testing application functionality, systems installation, resolution of connectivity and interface issues
ConfidentialDIRECTOR OF STAFF DEVELOPMENT
- Promoted from Staff RN to Director of Staff Development responsible for annual and new hire education and training
- Enhanced training program by researching and developing new content to augment dementia care program
- Contributed knowledge of Quality Improvement as facility representative to corporate QI focus group
Confidential, Pottstown, PAHOSPICE & PALLIATIVE CARE NURSE
- Case management of hospice and palliative care patients by nursing process
- Directed and coordinated care with the interdisciplinary team collaboration with facility and/or hospice staff to develop and execute plan of care.
- Increased efficiency, throughput and productivity by redesigning workflow and cross training staff
- Reduced operating expenses by measures such as reduced overtime, better record handling, workflow redesign
- Managed the daily operations of medical Confidential supported 6 providers; supervised/coordinated 10 staff activities including: coding billing, scheduling, insurance issues and authorizations, vendor management, triage
Confidential . East Orange, NJ
- Managed processes, employee relations issues, and data related to claims submitted to the federal Office of Workers’ Compensation Programs (OWCP) from VANJHCS, ensured compliance with regulatory requirements and timely filing.
- Scope: employee population 3000, 2 hospitals and 7 outpatient clinics, 600 injuries and 250-300 active cases/yr.
- Reduced turnaround time by: vigorously pursuing accommodations and light duty assignments; thorough record review and investigation; rapid claims handling. Identified and resolved employee safety incidents
- Improved employee relations by facilitating expeditious and appropriate resolution of matters related to lost time, accommodations, continuation of pay and other WC related issues with supervisors and employee.