Sr. Medical Affairs (Document) Specialist

STRENGTHS:

●I make adjustments to the roles performed to better suit the needs of my Teams. Communicating openly and assessing tasks as needed rated by priority daily.

●I have shown my ability to be flexible. Quickly and efficiently alternating between numerous daily tasks simultaneously. Continuously changing direction of my tasks, depending on the daily priority and needs to be accomplished.

●Time and consistency have proven the strength of my working with each new challenge that has been presented.

●I take the initiative to streamline the process of being time efficient in my work. I am proactive in seeking ways to improve my performance and that of our team when a need is shown in a specific area.

●I am trusted with confidential information and have proven this trust is well placed. I keep confidences without fail.

EXPERIENCE:

Position: Sr. Medical Affairs Specialist w/ Global Medical Affairs (GMA) - Medical Research Support (MRS)

Support: Investigator Initiated Studies (IIS), Affiliate Sponsored Post Marketing Observational Study (PMOS) & PH IV, Compassionate Use Cohort & Single Patient IND (sIND) studies, I-SPY2, Pre-clinical studies

Therapeutic Areas supported: Oncology, Immunology, Renal, Respiratory, Anesthesia, Cardiovascular and Neuroscience

●Manage IIS and Affiliate sponsored study applications submitted via AbbVie web system (Insights) in preparation for Scientific Review Committee (SRC) review.

QC for:

oAlignment with the Therapeutic Area (TA) Scientific Priorities Strategy.

oCompleteness of Application: Request revisions or Additional Information as necessary.

oQualification of Investigator

●Communicate document requirements to domestic sites, Affiliates and ex-US scientific personnel to collect required documentation for processing upon new study approval once SRC review decision has been formally communicated.

●Affiliate Sponsored PMOS / Ph IV studies:

oReceive, review and route SOP required documents for final Medical Affairs review/approval of: Protocol, Protocol Checklist, PMOS Pass form, Informed Consent Form (ICF), ICF Checklist Form 11, Monitoring Plan, Safety Plan, Site Selection Plan.

oRoute final Clinical Study Report (CSR) through approval process and to Medical Writing/Word Processing for upload and obtain final electronic signature.

●US Studies: Investigator Initiated Studies (IIS), Compassionate Use, CTEP (Cancer Therapy Evaluation Program) and Pre-Clinical studies

oReceive, review and process study documents from SRC approval to expedite study start and Investigational Product drug shipment (if applicable) through study completion/close out.

oRequest Confidentiality Disclosure Agreement (CDA), Material Transfer Agreement (MTA) or Contract via OSCAR (internal contracting system) –follow through process with Outsourcing till Final Execution.

oProcess Invoice payments met w/ supporting documentation per contract milestones met.

●Maintain the Trial Master Files (TMF): Hard Copy/ Paper & Electronic TMF (Insights) and Investigational Product Files:

Ensure;

o Documents maintained in the file are appropriate based on study type and the document content is accurate, complete and in compliance with SOPs and regulatory requirements.

oScientific, Regulatory and FDA related IND documentation is in TMF and uploaded to Insights.

oArchival of: completed, declined and cancelled studies to RICs per the SOP standards.

oAudit readiness for: quarterly Office of Ethics & Compliance (OEC), quarterly Monitoring and Medical Research Support (MRS) Self-Audits, yearly FDA mandated Earnst & Young Corporate Integrity Agreement (CIA) Audit

Participate in, prepare and provide document packets to applicable Auditor as requested.

●IMPACT (internal database): Submit required documentation to Clinical Program Group (CPG) for:

oRequest of a debarment check- enabling assignment of a unique identifier RIC # for new Investigators.

oAssignment of a Protocol # for new study entry into IMPACT.

oIND information for sites to receive Serious Adverse Event (SAE) safety notification letters via IMPACT

oEntry of Site information and Drug Shipping/ Recipient information, if applicable

Follow up with Global Drug Supply Management (GDSM) to confirm entry into Clinicopia for studies involving Investigational Product in preparation of routing packet for Quality Control & Compliance (QCC) approval for Investigational Product drug release.

●Update studies in internal databases daily as data changes are received.

●Ensure compliance within FDA Corporate Integrity Agreement (CIA) directives.

GLOBAL DRUG SUPPLY MANAGEMENT (GDSM) / Investigational Product (IP) Drug:

●Quality Control & Compliance (QCC) / Investigational Product Drug Approval:

oPrepare internal drug release Form 19 for US studies and route document packet for Review & Approval by Quality Control & Compliance (QCC) for drug release.

oReceive and review Affiliate Form 19 for errors prior to routing for Quality Control & Compliance (QCC) Approval for Investigational Product release.

●Process initial and resupply Investigational Product requests for both US and ex-US studies

●Maintain tracker of Investigational Product shipments to sites and expiry for IIS

●Create Investigational Product Drug Expiry Notifications to sites. Send Notification (and labels for relabel if applicable) Collect site attestations as documentation of relabel or destruction.

oCreate and Execute Clinical Supply Expiry/Retest Action Plans for Investigational Product drug expiry / extensions per affected site.

●Collaborate with Quality Control & Compliance (QCC) and Global Drug Supply Management (GDSM), Supply team (Clinicopia) and Affiliate Manager for creation and implementation of Investigational Product (IP) release process for IIS & Affiliate sponsored studies

●Subject Matter Expert (SME): Created Work Instructions for Investigational Product drug approval - Investigational Product (IP) release- process for:

oRest of World [ROW] Investigator Initiated Studies [IIS] (ex-US)

oNorth America Investigator Initiated Studies [IIS]

oCompassionate Use [CU]

System use:

●OSCAR: Request Confidentiality Disclosure Agreements (CDA), Material Transfer Agreements (MTA) Contracts and Amendments, as applicable.

●IP Manager (Intellectual Property): Routing of Publications/Abstracts/ Posters for Scientific and Legal approval prior to external publishing.

●INSIGHTS: Med Affairs Specialist Administrator of Insights for Renal, Oncology, Anesthesia, Respiratory, Cardiovascular and Neuroscience

●IMPACT: Submit US & ex-US studies for entry. Update study data in the system for US IIS studies

●ART

●GEARS

●Sentinel

●Quantum

●COMPASS

●Pharma Docs

●eDocs

●IVRS: Clinical Trial Drug Supply management system - previous experience with Clarix

●Proficient in Excel, Word, Powerpoint, Visio, Data Management, Insights2 (web external Investigator application submission portal for document and data management of clinical and pre-clinical studies)

Additional role w/ AbbVie Global Medical Affairs – outside of scope of Sr. Medical Affairs Specialist role:

Logistic Assistance for AbbVie Logistic / Space Location Team: February 2015- June 2017

●Sole GMA person chosen to be trusted for this role.

●Assisted AbbVie Logistic / Space Planning Team for placement of 300+ Global Medical Affairs (GMA) existing employees and new hires.

●Updated internal Space Location database for 300+ GMA employees for accuracy of their location i.e. Building, Space ID at Abbott Park.

●Assisted with assignment and move of all GMA employees move to new AbbVie1 (ABV1) Meetawa location.

●Created tracker for all new hires to ensure cubicles assigned were not duplicated / double booked.

●Created a Work Instruction for Onboarding of new Employees:

●Shared company wide as the tool for Administrative Support staff to use as the process of onboarding new employees. First line item was to provide me the new employees hiring details of Role/Grade/ Start Date to allow me time to sync with Space Team for proper cube assignment.

●Confidentiality was imperative with this extremely confidential information of all employees, including Upper Management.

Contributing Member of AbbVie Committees:

SOP revisions:

●IIS SOP

oProvide input for revision of IIS SOP

oRevise SOP Essential Documents list for submission with revised SOP.

Develop and implement Work Instructions / Glossary to compliment Essential Documents listed in IIS SOP.

Develop a User Guide to assist in defining actions / explanation of Essential Documents required per the newly revised SOP.

●Investigational Product (IP) Process Improvement Team:

oClinical Supply Expiry/Retest Action Plans (EAP):

Contribute to revision of Clinical EAP template

Develop new “IIS Specific” EAP template

o Investigational Product Process:

Collaborate with Global Drug Supply Management (GDSM) DSMs: Provide IIS information of Investigational Product drug process for creation of process visio to roll out new process globally.

●Drug Destruction:

oDrug Destruction on-site (SOP): Provide input for revision of SOP regarding Drug Destruction on-site or via 3rd party vendor.

oDrug Destruction on-site (Contracts): Provide input for consideration of changing contract language for on-site Drug Destruction.

Subject Matter Expert (SME) Contributions:

●Training: Affiliate Sponsored Study -Investigational Product Processing

Provide training on Investigational Product (IP) processing to Affiliates who will be managing / conducting Phase IV studies. Collaborative training with Quality Control & Compliance (QCC) member.

Collaborated with Quality Control & Compliance (QCC) member to create slide deck Work Instruction guide for Investigational Product (IP) Process used for training.

●MHRA Audit: Completed all requested tasks expeditiously, to be in inspection ready compliance for the MHRA Audit of IMPACT and other files.

●OEC Audit, MRS Self-Audit, Quarterly Monitoring Audits.

●Creation of Investigational Product (IP) process for US and ex-US sites for ABT-888 IIS and Compassionate Use, ABT-869 IIS, ABT-751 sIND and Patient Named Basis (PNB).

●Contributing participant in the creation of the Investigator Portal Project – (ACE)

●Contributing participant of creation of Insights 1 and Insights 2:

●Investigator Brochure – provide study information/QC for yearly IB update.

●Subject matter expert on creation of the Compassionate Use SOP and related Work Instructions.

●Subject matter expert on creation of Work Instructions for Investigational Product (IP) approval / release process for:

Rest of World Investigator Initiated Studies [IIS]

North America Investigator Initiated Studies [IIS]

Compassionate Use [CU]

●Contributor to creation of the ACE portal

●Immunology Clinical Team participant of Abbott’s first eSubmissions to the FDA for Humira 2004, including proofing of content, checking hyperlinks, uploading documents with proper naming conventions for routing for approval.

Naval Station Great Lakes: Assistant to Director of Operations -Goodwill of S.E. Wisconsin:

Administrative Support as required: correspondence, meeting minutes, creating agendas, etc.

Track daily utilization per Galley and in overall monthly summary report.

Create /maintain spreadsheets using Excel and Access Track On- Base headcount

Schedule meetings Plan luncheons and dinners for the Admiral’s visits with Foreign Dignitaries and guests.

Coordinated uniform issue for 950+ civilian employees.

Coordinated with HR task force to hire 1000 civilian employees for opening and staffing 3 new barracks/galleys within a 2month time deadline.

oOrganized weekly Job Fairs at a local hotel.

oReviewed applications /Interviewed applicants

oCo-presenter of weekly Orientation for new hires.

oCoordinated and conducted bus tours of the base for new hires.

EXPERIENCE STARTING WITH MOST RECENT POSITION

DATE

FINAL POSITION

AbbVie / Abbott Laboratories

March 04 – June 17

Sr. Medical Affairs Specialist / Document Management Team +Space Planning

Goodwill of S.E. Wisconsin.

February 01 – November 03

Assistant to the Director of Operations-Goodwill of S.E. Wisconsin. Naval Station Great Lakes

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