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Documentation Specialist
Ref No.: 18-01366
Location: spring House, Pennsylvania
Position Type:Direct Placement
Start Date: 02/07/2018
Position Summary:
• Provide document and publication support for entire Medical Affairs Publications group across all products. Maintain records for various types of documents (electronic and/or hardcopy) in accordance with Health Insurance Portability and Accountability Act (HIPAA) and internal regulatory guidelines.
• Provide general administrative support to the Senior Director, Medical Affairs Writing Group and staff. Maintain calendars, prepare expense reports, arrange large-forum document review meetings and prepare agendas. Arrange detailed travel plans and itineraries; generate meeting agendas, group meeting minutes for distribution, and assist with preparation of PowerPoint presentations.
Responsibilities:
  • Provide meeting scheduling support with internal and external professional contacts including meeting coordination with external authors. Coordinate and arrange meetings for the Medical Affairs Writing Group at large including group meetings and functions.
  • Serve as Publication Coordinator by circulating and coordinating the internal review of publications, and document internal review from: (a) Regulatory representative as per GDL-06016, and (b) CDTL, GMAL, Legal/Patent representative as per SOP-10100.
  • Provide general administrative support to the Senior Director, Medical Affairs Writing Group and staff. Maintain calendars, prepare expense reports, arrange large-forum document review meetings and prepare agendas. Post/upload the publication tracking sheets to the SharePoint site from the GI and Rheumatology Publication Team meetings. Maintain a journal library for the group. Provide a receptioning function to the Medical Affairs Writing Group at large. Assist the team with meeting preparations, WebEx set up, training, and meeting preparations, IT support requests, and tasks as assigned.
  • Procurement of document approvals and signatories; preparing professional internal correspondences, assist with procurement of copyright approvals; securing and filing author disclosure forms; support record document retention in accordance with legal and regulatory guidelines; scan and provide the original signature sheet for regulatory documents to the appropriate individual as directed. Serve as Records Coordinator for Medical Affairs at the Spring House location. Maintain all training logs and absences/paid leave records for the group.
Qualifications:
  • Associates Degree - in Sciences, Strongly Preferred
  • Demonstrated proficiency in Microsoft Office programs (Word, PowerPoint, Outlook and Excel).
  • Must have good oral and written communication skills, and strong organizational skills.
  • Must be able to manage multiple priorities, and maintain confidentiality.
  • Must be proficient in document reviews.
  • Ability to work well in a team environment, showing strong initiative and desire to learn. Must exercise sound judgment and attention to detail. Must have the ability to relate on a professional level with fellow colleagues.
  • Inside the company: Daily interaction for purposes of meeting scheduling and publication review/coordination duties.
  • Outside the company: Occasional interaction needed in order to schedule meetings and as needed to provide administrative support to the Senior Director and staff.