Senior, Medical Writer - Marlborough, MA | Biospace
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Senior, Medical Writer

Sunovion Pharmaceuticals Inc.

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Location:
Marlborough, MA
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
6002BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Medical Writer,

Job Description

The Senior Medical Writer will lead medical writing initiatives within R&D across various therapeutic areas, collaborating with both local and global cross-functional teams for Phase 1-4 clinical studies, including IND and NDA sections.
Direct and lead the writing, reviewing, editing and approval of clinical documents
Author documents while contributing knowledge of therapeutic areas, clinical drug development, and scientific areas.
Provide medical writing and editing expertise for various documents including those for clinical development and medical affairs (clinical study outlines, clinical protocols, amendments, reports, etc.), and for regulatory submission documents (IND applications, NDA, meeting packages, etc.).
Understand and interpret data from a variety of sources and help create figures/tables to effectively communicate clinical study results.
Review documents related to clinical study reports, such as Statistical Analysis Plans and tables, figures and listings.
Ensure documents are developed according to timelines.
Learn and maintain a knowledge of relevant therapeutic areas in order to apply knowledge to various projects.

Requirements

Bachelor’s degree in science with relevant writing experience OR Bachelor’s degree in English or Comunications with significant relevant scientific experience; PhD, PharmD OR Master’s degree highly preferred.
3-5 years of relevant pharmaceutical and/or medical device industry experience, with at least 3 years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/NDA sections).
Strong interpersonal and teamwork skills.
Excellent oral and written communication skills.
Strong organization skills and a high attention to detail.
Strong working knowledge of Adobe PDF, MS WORD, EXCEL, PowerPoint, and Project
Experience with automated document templates and AMA style guide.
Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures.