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location: Cambridge, Massachusetts
job type: Contract
salary: $48.92 - 57.56 per hour
work hours: 9 to 5
The main purpose of this position is to provide medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials
- Prepares clinical documents with supervision
- Participates on clinical teams (e.g., SMT) with supervision; participates in document-related meetings led by senior writers; reviews clinical data reports as needed
- This position interacts with other medical writers and document quality reviewers and has limited interaction with cross-functional teams (e.g., SMT), in order to create/author/manage documentation required to support clinical trials and regulatory submissions. May participate in cross-functional meetings with supervision.
- Receives direction on document preparation, data review, timeline management, and meeting skills.
- Demonstrates increasing familiarity with internal and external guidelines related to content and format of clinical documents.
- Recognizes problems with completing tasks and develops solutions with direction.
- Depends on management to prioritize tasks.
- Provides information to management to facilitate decision making.
- Decisions affect primarily study activities
- Bachelor's required Master's or PhD preferred
- Life or Health Science discipline
- 3+ yrs regulatory, scientific, or publication writing experience with Bachelor's 2+ yrs regulatory, scientific, or publication writing experience with Master's 0-1 yr regulatory, scientific, or publication writing experience with PhD
- Good organizational and meeting skills.
- Solid understanding of scientific and/or clinical research.
- Ability to interpret data.
- Familiarity with standard clinical document types.
skills: Submissions, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.