Senior Manager, Medical Writing Operations

North Chicago, IL, US
Oct 19, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Senior Manager of Medical Writing Operations is responsible for the management and oversight of the Medical Writing Operations (MWOs) Medical Writing Coordinating/Report Publishing (MWC/RP) group, including: oversight of the Medical Writing Coordinators, who compile CSR Appendix 16 documents (including casebooks) and source literature references for all Medical Writing document types, ensuring timely completion, accuracy, and submission-readiness; oversight of the Report Publishers, who electronically compile submission-ready clinical regulatory documents using publishing software tools, perform quality checks of published output to verify accuracy of electronic navigation characteristics (i.e. bookmarks, hyperlinks, table of contents); and, the oversight of Coordinators/Report Publishers, dual-role position who perform both the Coordinator and Report Publisher roles interchangeably.

Manage strategic clinical regulatory document planning efforts to fulfill objectives. Responsible for development, implementation, and maintenance of documents and/or business systems utilized for clinical regulatory document support for development teams. Provide managerial oversight of internal staff member(s) that support multiple compounds and/or indications of a major or complex product within a therapeutic area, including oversight of work product and activities. Address and resolve product area issues. Interface with functional groups (e.g. PK, Toxicology, Regulatory, Statistical Support, Data Management, Clinical) and writers (internal and external vendors) to ensure timely completion of projects that are scientifically accurate and of high quality.

Manage 8-10 direct reports including both exempt and non-exempt, open to individuals with submission publishing background and complimentary/related degrees, etc.

Key Responsibilities Include:
  • Manages strategic clinical regulatory document planning efforts to fulfill objectives. Accountable for meeting the main objectives of clinical writing projects in therapeutic area(s) within established timelines, budgets, and with an appropriate quality level.
  • Provides oversight and project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, ensuring accuracy and adherence to timelines and processes.
  • Provides managerial oversight of staff member(s) that support multiple compounds and/or indications of a major or complex product within assigned therapeutic area, including oversight of work products and activities.
  • Works with development team and functional area to execute project objectives and strategies. Establishes, maintains, and expands business relationships with all functional areas collaborating on projects.
  • Communicates effectively across functional areas and within department to accomplish project objectives.
  • Presents project and professional information to appropriate individuals in a concise, clear, and objective manner, and with grammatical accuracy. Represents functional area on routine issues and facilitates multidisciplinary communications.
  • Proficiently learns and applies therapeutic area and product knowledge to scientific projects.
  • Develops expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation and production of clinical documents and ensures staff understands, complies, and applies them to work products.
  • Implements systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality.
  • Oversees writing projects to ensure timely completion. Must resolve conflicts, remove barriers, and generate innovative ways to ensure teams achieve project goals.
  • Independently evaluates data and business needs, identifies opportunities and risks, weighs alternatives, and presents recommendations to product team and/or management.
  • Knowledgeable about the product/disease state and is an expert on clinical documents.
  • Continually trains/be compliant with all current industry requirements as they relate to clinical regulatory submissions.

  • Bachelors degree in English or Communications with relevant science expertise or Bachelor degree in Life Science with relevant writing expertise. Advanced degree and/or professional certification/credentials preferred.
  • 3 years relevant industry experience required; 5 years relevant experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D; 4 years experience in experimental design and clinical/preclinical data interpretation required; and, 2 years in a project management role required.
  • Demonstrated abilities in a staff oversight capacity.
  • Working knowledge of applicable regulations and legislation.
  • Ability to form, maintain, and lead productive cross-functional working teams, including addressing issues that arise. Collaborative teamwork and leadership track record. Excellent business communication skills with aptitude for summarization, as well as detail orientation.
  • Experience developing and delivering presentations to senior management.
  • Ability to understand and interpret medical data and create and develop strategic messaging required.
  • Knowledge of product therapeutic area preferred.
  • Microsoft Office and Internet navigation proficiencies essential. Working knowledge of statistical concepts and techniques required. Working knowledge of other business-related information technology.
  • Identify and employ rigorous logic and methods to independently and effectively solve difficult problems within and outside routine work situations. Recognize potential scheduling and resource conflicts for project and provide recommendations to resolve. Probe multiple sources for answers. Identify hidden issues and problems beyond the obvious. Appropriately identify when to independently address the situation and when to elevate the issue to management and/or development team(s) for resolution.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled