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Medical Writer (1443)
Ref No.: 18-27731
Location: Spring House, Pennsylvania
Position Description
POSITION SUMMARY: Remote opportunity
Independently write and/or manage the most challenging publications (including, abstracts, posters, oral presentations, and manuscripts).
Take responsibility for overall production and delivery of publications and other documents as assigned.
Directly support assigned US Medical Affairs writing projects as well as write abstracts, posters and/or manuscripts for clinical projects (Phase 1-4) with the help of other functional areas.
Represent the Medical Affairs Publications Group on publication and/or therapeutic area teams.
Demonstrate excellent document management skills in moving publications forward, prioritizing work assignments, conflict management, and problem solving.
Demonstrate excellent project management skills in coordinating comment review meetings, meetings with internal and external authors and partners, and other meetings as required to deliver publications within agreed timelines.
Knowledge of relevant publication guidances including but not limited to International Committee of Medical Journal Editors (ICJME), Good Publication Practices (GPP), Consort Guidelines, American Medical Association (AMA) Manual of Style, Council of Biology Editors, etc.
Job Description: Location: Spring House, PA
ESSENTIAL FUNCTIONS:
Writing
Manage assigned writing projects
JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED:
Writing includes but is not limited to:
Manage and/or provide expert, independent writing support for assigned documents and/or publication/therapeutic area team(s). Documents may include but are not limited to abstracts, posters, oral presentations, and manuscripts. May assist with electronic submissions of abstracts, posters, oral presentations, and manuscripts.
Interface with authors on abstracts, posters, oral presenttions, and manuscripts.
Manage and/or write, edit, and revise abstracts, posters, oral presentations and/or manuscripts. As agreed upon by the lead author, develop any or all of the following: publication outline, publication shell, draft publication, as well as various other written sections of publications.
Manage and/or review and interpret data and source documents for information required for publication development. Assist in table and figure mock-up development.
Identify and resolve, with the help of other functional areas, clinical and statistical issues in the interpretation of clinical data.
Participate in the development and maintenance of document templates, style guides, electronic document management and publication system, and SOPs.
May perform other duties as assigned.
Manage assigned writing project includes but is not limited to:
Provide support and representation to assigned therapeutic area publication team.
Manage document development timelines to facilitate timely submission.
Maintain annotated versions of documents and facilitate review cycles.
Facilitate, collate, and adjudicate author and reviewer comments.
Adjudicate and address quality assurance (QA ) review.
Verify completion of mandatory approvals (eg, Legal, Patents, Regulatory Affairs) prior to manuscript submission.
May perform other duties as assigned.