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Medical Writer

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We're working with a global client to find a Medical Writer to join their team in Woodcliff Lake, NJ. In this role, you'll work with clinical study teams, oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.

Start Date: ASAP
Location: Onsite at our client's office in Woodcliff Lake (Ideally onsite 5 days per week, but 3 days onsite and 2 days remote is a possibility)
Duration: 1 year
Hours: 40 per week
Job Type: Contract; W2 through Aquent

Responsibilities:
-Help in the preparation of regulatory documents in accordance with the ICH guidelines, international regulations, company standards and processes, and the company writing style guide as applicable.
-Documents include but are not limited to: Protocols and protocol amendments, clinical safety reports, narratives, and Investigator brochures.
-Manage the document review process, routing documents for approval using an electronic document management system (eDMS), performing Quality Control (QC) checks, and compilation of CSR supporting documents and submission documents.
-Format and manage long documents with multiple review cycles and tight deadlines, and to work with the submission manager to compile and prepare documents for submission.

Requirements:
-Familiarity with ICH guidelines, ISI writer templates, document management systems, and the current AMA Style Manual.
-Ability to write documents in collaboration with the various members of study team.
-Bachelor's degree in life sciences, RN, or Master's degree in life sciences.
-Excellent quality control, formatting and editing skills, meticulous attention to detail, and prior experience of using programs like Visio, Power Point, proficiency using an eDMS and standard style guide.
-5+ years’ similar work experience in the pharmaceutical industry.
-Prior experience in oncology is a plus.

Interested? We'd love to hear from you?
-Updated resume.
-Summary of experience related to above.

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