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Medical Writer

Albany County, NY


Medical Writer

Ref #: 17707

Employment type: Permanent - Full-Time

Location: Remote/Home-based

Posted: 13-May-2020


Principle Responsibilities:

- Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documentation.

- Contributes to project plan concerning organization and table layout for a specific document.

- Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.

- Review study concepts and edit protocols for consistency, progression, structure, and grammar.

- Review statistical analysis plans and incorporate into clinical study reports.

- Drive the document preparation process, receive and review primary statistical output, draft and distribute document for review, and compile comments and edits as necessary.

- Participate in team and client meetings as requested.

Education and Experience Requirements/Qualifications:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred

• At least 5 years of pharmaceutical industry experience in the clinical/regulatory field

• Global regulatory submission experience.

• Excellent writing skills.

• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.

• Knowledge of current requirements and guidelines applicable to submission documents

• Excellent interpersonal and oral communication skills.

• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook

• Ability to prioritize multiple projects

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.