Proclinical is currently recruiting for a REMOTE position as a Technical Writer with a pharmaceutical company.
- 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.