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Manager‚ Medical Writer

Job Description
Responsible for researching‚ writing and editing clinical reports‚ summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation. Will also contribute to the development of formats and guidelines for clinical documentation. May also support CRAs and MDs in clinical protocol development. Remains informed of the latest professional‚ technological‚ and regulatory developments in medical writing‚ as well as therapeutic areas. Job duties/responsibilities include:

  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques
  • Manages all clinical writing activities outlined in the Project Clinical Development Plans.
  • Reviews documents‚ offers guidance‚ and takes lead in mentoring writers in the preparation of regulatory and publication documents.
  • Organizes‚ conducts‚ and leads document production meetings and other meetings as necessary.
  • Projects Medical Writing budget‚ resource‚ and timeline requirements for CDP.
  • Responsible for developing and managing‚ Departmental Guidelines management system‚ Writing style guide and departmental templates such as‚ protocols‚ investigator’s brochures‚ final clinical study reports‚ IND sections.
  • Proposes applications.
  • Provides and manages internal and external writing activities.

Education

  • A Bachelors/Masters degree in a scientific discipline with a strong journalism background is required. Equivalent experience may be accepted.

Skills

  • A minimum of 8 years in a pharmaceutical‚ biotech‚ or CRO medical writing position is required.
  • A minimum of 6 years writing management experience is also required.
  • A minimum of 5 years previous supervisory experience is required.
  • An ability to create effective presentations from raw data is essential.
  • An ability to interpret statistical and clinical data is essential.
  • Must have an ability to work well with others in high–pressure situations.
  • Must have demonstrated problem solving abilities.
  • Strong organizational skills are required.
  • Strong written and verbal communication skills are required.
  • An understanding of clinical research‚ biostatistics‚ and regulatory affairs is required.
  • Must have experience writing clinical protocols‚ clinical study reports‚ and IND sections.
  • Good computer skills are required. Working knowledge of MS word‚ Excel‚ Power point‚ Lotus notes is a plus.