Senior Manager, Medical Writing QC & Contracts

North Chicago, IL, US
Oct 13, 2018
Required Education
Bachelors Degree
Position Type
Full time
Responsible for the management and oversight of the Medical Writing Operations (MWOs) Quality Control (QC) group, including Medical Writing (MW) QC, MW QC contracts, MW Vendor Oversight Plans (VOPs), MW Quality Assurance (QA) audits/inspections, and related activities to ensure timely completion and delivery of high quality submission documents.

Key Responsibilities Include:
  • Must demonstrate good interpersonal and organizational communication skills.
  • Maintains strong knowledge of clinical regulatory documents requiring QC/QA as well as the development of related business processes and procedures for the QC/QA of these documents.
  • Demonstrates strong attention to detail and a high level of quality, consistency, and accuracy in work effort.
  • Participates and/or leads process improvement activities and related initiatives. Mentors and provides guidance/training to less senior MW staff or others as applicable.
  • Manage the overall QC schedule and assigning QC review of clinical regulatory documents. Review QC comments of group to ensure that consistency and quality is maintained.
  • Provide managerial oversight of internal and external employees/resources. Direct Reports/Exempts (N = 2-10). External resources (i.e. contractors, staff augmentation with the use of vendors) as needed. Non-Exempts (N = 0).
  • Responsible for initiating MW QC contracts and following them through execution, including the maintenance of contract actuals. Responsible for initiating MW VOPs and following them through execution. Provide/ensure that all related documentation is forwarded to Clinical Documentation
  • Center for the TMF/PF per the established business processes and procedures.
  • Accountable for monitoring and tracking QC/QA related metrics.
  • Accountable for meeting the main objectives of the assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
  • Drives the QC of clinical regulatory documents and MW VOPs to timely completion. Exhibits a moderate level of technical competencies and requires a moderate level of counsel and guidance.
  • Expedient escalation of issues to management is essential and may have a direct impact on the ability to meet project timelines. Daily interaction with Medical
  • Writers and/or MW managers as well as interface/communication with applicable crossfunctional areas and external resources.
  • Communicates and provides deliverables to Medical Writers, MW managers, and others as applicable.
  • This position is the third level (of 3 levels) within a job family which is responsible for MW QC.

  • Bachelor's degree (BA/BS) required. Bachelor's degree of Communication or English (with relevant science experience) is preferred. Advance degree is desirable.
  • American Medical Writing Association (AMWA) certificate or other similar credential is preferred, with a specialty in Pharmaceutical.
  • 3-7 years relevant pharmaceutical industry experience in MW, clinical research, quality, or related area such as regulatory or product support. 3 years relevant industry QC experience desirable.
  • 1-2 years management experience in QC/QA desirable.
  • Experience in quality review of clinical regulatory documents.
  • Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
  • Proficient experience in use of MS Office (e.g., Excel, OneNote, Outlook, PowerPoint, Project, Word), and, Adobe Acrobat.
  • Experience/familiarity with SharePoint, ISIWriter/Publisher, and eDocs desirable.
  • Project management experience required.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled