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Technical Writer
- Permanent
 - Analytical Chemistry, Biochemistry, Biological Sciences
 - United States
 
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a REMOTE position as a Technical Writer with a pharmaceutical company.
Job Responsibilities:
- Work closely with analytical development synthetic molecule staff to write and review relevant eCTD sections and analytical method validation documents (protocols, reports) for multiple projects
 - Evaluate analytical scientific data and define appropriate presentation for eCTD sections
 - Transcribe technical data from internal reports to eCTD sections
 - Manage writing, reviewing, editing/formatting, and data integrity activities for assigned projects
 - Review, edit, and ensure quality of documents or sections of documents prepared by other writers
 - Ensure that writing/reviewing activities are coordinated between analytical development and the project team
 
Skills and Requirements:
- Bachelor's degree required; Advanced degree in Chemistry, Biology or equivalent preferred
 - 7+ years of pharmaceutical industry experience required
 - Chemistry, Manufacturing and Controls (CMC) and regulatory document authoring experience required
 - Experience in analytical development required
 - Ability to understand and interpret analytical development data
 - Ability to interact effectively with team leaders/members and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
 - Knowledge of current regulatory requirements and guidelines applicable to analytical development (method validation, specifications, analytical control strategies for example)
 - Strong knowledge of MS Word, Excel, MS Project, PowerPoint, and Outlook
 - Working knowledge of template use for document creation
 
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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