Medical Writer (Regulatory) Job

Company Name:
Salary period: Annual
Medical Writer needed for a contract opportunity with Yoh's client located in Woodcliff Lake, NJ.
What You'll Be Doing:
- Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
- Responsibilities include prepare regulatory documents on behalf in accordance with the ICH guidelines, international regulations, standards and processes, and the Writing Style Guide as applicable.
- Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents.
- Participate in project team meetings to provide input regarding deliverables, timelines, and processes.
- Responsible for managing the document review process.
- Route documents for approval.
- The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.
- The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.
What You Need to Bring to the Table:
- Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred.
- Five (5) plus years of writing experience in the pharmaceutical industry
- Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 2-3 days minimum onsite.
- Excellent writing skills, meticulous attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data.
Opportunity is Calling, Apply Now!
Recruiter: Krista Leach
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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