Pharmaceutical Manufacturing

GBR&D Operations Associate - Lake Forest, IL, US and International, Scientific/Bio-Analytics Team. Facilitate operations (~$50M/yr.) for scientific team, including capital equipment, contract research and testing agreements, CDAs, and other business support activities for GBR&D team.-Capital planning/purchases for lab equipment through effective communications with finance team for corrective coding of purchase order entry and invoicing approval in ARIBA.-Operation management/development and execution of required R&D business contracts agreements (i.e., SOW, Quotes CDAs and MSAs) via SAP ARIBA system.-Manage product portfolios for (P2P) Procure-to-Pay process via ARIBA (SME) including, but not limited to: processing, tracking and troubleshoot requisitions and invoices for purchase orders (POs), purchase order change notices (POCNs) and requests for capital expenditures process goods receipts (GRs); track issuance of payments; maintain electronic records of all supporting documentation (i.e., agreements, contracts, contract amendments, statements of work and quotes).-Generate monthly metrics reports for Senior Management (Finance, Lab Safety Observation/Audits)-Executional Excellence training for new hires at our Lake Forest and Chennai India sites (via WebEx). Employee engagement, training and recognition initiatives. Coordinate technical seminar series and other scientific events within GBR&D.-Develop, implement and support communication tools to facilitate collaboration globally across GBR&D between U.S. and International sites via SharePoint.-Export/Import shipping for lab testing of animal samples, specimens and materials US and International.-Manage on-boarding activities for LF-based R&D employees. Work closely with managers to ensure efficient integration of scientific staff into GBR&D and CSO organization while serving as primary liaison with facilities group for ongoing space planning and facility related issues.

• Speaker Program Operations P.O.C., data analysis, communications, training and compliance issues related to Speaker Program attendees that have affiliation with Massachusetts, Vermont, Minnesota and VA Hospitals• Enhancements with improved report monitoring for Federal/State government requirements within the PSP system.• Implementing changes related to recent external Astellas Speaker Program Audit.• 2012 and prior Speaker Program Closeouts and working with Field Sales and Vendors to ensure accuracy and completeness of data within the PSP system.• Creation of SharePoint and new documents for reps (i.e. (Institutions and Speakers) Physician Sign-in Sheet, attendee affiliation handouts (MA, VT, MN and VA), placards for meals and rep training PowerPoint Presentation.• Document approvals through M.A.P. (Material Approval Process) system.

Responsible for review of all advertising, promotion, sales training and promotional labeling material by cross functional team (medical, regulatory, legal, compliance, and others) as required by corporate quality policies. • Served as liaison for all individuals within the approval process and provide support for routing projects through Marketing/Medical Affairs/ Scientific Affairs and Regulatory approval process.• Implements and maintains the quality policy according to Q doc. • Identified and report potential gaps which may lead to nonconformance or observation.• Coordinate ePAS approvals for AdPromo, print and Web, including quarterly and annual reviews.• Author packages and assist with preparation of reviews (adding attachments— i.e. Package Inserts/Supporting Documentation, etc).• Provide metric reports as needed for quarterly and annual reviews. • Reviews for the acceptability of Corrective and Preventive Actions (CAPA) resulting from audit observations and follows through to assure that procedures comply with CAPA plans. • Assists in department or divisional audits regarding promotional material. Pulling data lists and collecting material. • MarCom ePAS SME (subject matter expert) point of contact. Assist users with ePAS questions and new employees with obtaining ePAS access via WebEx or Webinars training.• Assist with migration process of moving documents from ePAS to SharePoint.• Liaison with Regulatory Affairs coordinator to ensure reviews are scheduled and appropriate reviewers are assigned. • Worked with Brand and Product Managers regarding inventory for out-of-stock/up-for-review materials (heavy vendor contact).• Assist with monthly distribution warehouse reports (notifying appropriate contacts of items that are up for review or that have fallen out of inventory).• Posts monthly report to the Marketing Portal to communicate the usage of materials.

Worked with law department to manage confidential lawyer files in documentum.• Scanned, documented and managed files in Access database to ensure accuracy and maintain staff confidentiality.• Merged TAP and Takeda data into Apex system to meet project deadline with no service interruption.• Updated internal/external job descriptions in Taleo.