Senior Medical Writing Document Associate / Associate Medical Writing Document Manager

Astellas Pharmaceuticals - Northbrook, IL (30+ days ago)3.9


Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Senior Medical Writing Document Associate / Associate Medical Writing Document Manager opportunity in Northbrook, IL.

Purpose & Scope of Position:
Acts as a Document Working Group Facilitator (DWGF; document lead medical writer) and is responsible for leading document related writing activities, and coordinating and managing the writing tasks within a multidiscipline document working group. Documents are complex (generally Investigator's Brochure, standard briefing documents/request for scientific advice, clinical study report [CSR)]; Level II more complex than Level I). As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the document working group. May perform writing tasks within a document working group and may perform editorial activities, including review of work by writers.

Essential Job Responsibilities:
  • Acts as a DWGF (complex documents but generally less complex than those created/managed by more senior DWGF [Level III]).
  • Level II performs the responsibilities/duties independently; generally complexity is on the level of an Investigator's Brochure or standard briefing documents/requests for scientific advice.
  • Level I performs the responsibilities/duties in a self-directed manner but the activities and progress are reviewed by the GMWRL; generally complexity is on the level of a CSR.
  • Coordinates, manages and facilitates the tasks necessary for document drafting, review and completion, meeting internal and external customer needs, within a document working group.
  • Level II performs these responsibilities/duties independently.
  • Level I performs these responsibilities/duties in a self-directed manner but the activities and progress are reviewed by the GMWRL.
  • Develops and executes an agreed upon and complete document work plan, with all needed writing tasks and subtasks that enables the working group to work efficiently and effectively.
  • Level II performs these responsibilities/duties independently.
  • Level I performs these responsibilities/duties in a self-directed manner but the work plan is reviewed and may be amended by the GMWRL.
  • Acts as a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the document working group. (Contribution will be commensurate with experience).
  • May perform editorial activities, including review of work by writers.
  • May perform writing tasks within a document working group including drafting and revision of drafts addressing all comments in collaboration with responsible content authors and scientific document lead to ensure document quality in regard to correctness of structure, content, language, and/or style.
  • Assists more senior staff by providing requested input regarding writer performance in document working groups (Level II).
Quantitative Dimensions:
  • Contributes to the quality and performance of CROs and staff, impacting costs and program success.
  • Directly or indirectly responsible for oversight of Medical Writing document preparation activities with each individual document budget of $50,000 to $120,000 and for a total of up to $1M/year.
Organizational context:
  • Reports to a line manager within Medical Writing. Does not have any direct reports although may review the work of other writers including CRO. Project track, document responsibilities role.
Qualifications:
Required

  • BA/BS degree
  • 3+ years relevant experience and/or advanced degree (PhD, MS, MA, etc)
  • Able to complete work independently
  • Demonstrated ability to communicate complex technical information in written form
  • Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks
  • Good analytical and organizational abilities
  • Good interpersonal skills to effectively work in cross-functional teamsPreferred
  • 3+ years (Level II) / 1+ year (Level I) experience in writing regulated documents.
  • Line management experience/demonstrated ability to direct the technical work of others.
  • LI-VB
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled