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Medical Writer III (3379)


Summary:
The position develops clinical documents that are of high quality and prepared within timelines.
Responsibilities:
1) Develops clinical documents ensuring scientific excellence. The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, leading team meetings, and ensuring delivery within timelines. Clinical documents may include investigator brochures, clinical study reports, integrated reports, summary reports, manuscripts, abstracts, posters, and presentations.
2) Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and client procedures (as applicable). Includes collaborating with medical editors to ensure documents are publication ready.
3) Contribute to therapeutic area strategic product development by reviewing concept sheets and protocols and managing protocols through the development process. May also review case report forms and statistical analysis plans.
4) Participate in study team meetings.
5) Develop knowledge of all therapeutic areas.
Qualifications:
o Expertise in scientific and/or medical writing o Expertise in the analytical evaluation of scientific data o Exceptional organizational skills and meticulous attention to detail o Apply global regulatory authorities regulations and/or guidance o Manage multiple projects with competing priorities o Work in a team environment o Show competence in leadership and project management skills Knowledge of computer software (especially Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus).
Education and/or
Experience:
The Medical Writer III must have an academic science or clinical degree direct experience in scientific/medical writing in a pharmaceutical company as follows: a PhD or MS in a scientific discipline with direct experience (at least 1 year) in medical/scientific writing.

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