Medical Writer Job

MEDICAL WRITER needed for a CONTRACT opportunity with Yoh's client located in WOODCLIFF LAKE, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Regulatory writing skills
- Experience with ICH guidelines and the current AMA Style Manual
- Oncology medical writing experience

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.
- Responsible for the preparation of regulatory documents in accordance with the ICH guidelines, international regulations, standards and processes, and Writing Style Guide as applicable.
- Prepare 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.
- 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.
- 5+ years' writing experience in the pharmaceutical industry.
- Excellent regulatory writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data.
- Familiar with ICH guidelines and the current AMA Style Manual.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Chelsea Tevis

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WMIDATL

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SFSF: LS