Technical Writer job in Cambridge, USA

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First Name*

Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Analytical Chemistry, Biochemistry, Biological Sciences

Location: 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.

#LI-ZH1

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