Senior Medical Writer Job

A SENIOR MEDICAL WRITER needed for a contract opportunity with Yoh's client located in Woodcliff Lake, NJ.

The Big Picture - Top Skills You Should Possess:

- Medical Writing
- Prepare regulatory documents
- Write Protocols

What You'll Be Doing:

- The Medical Writer will 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 of the company in accordance with the ICH guidelines, international regulations, standards and processes, and the company's Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator Brochures, and submission documents.
- The Medical Writer will also 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.
- Work 40 hrs ONSITE, will eventually work 2-3 days remotely.

WHAT YOU NEED TO BRING TO THE TABLE:

- Master's degree in life sciences, RN, Master's degree in life sciences.
- Minimum of five (5+) years' medical writing experience in the pharmaceutical industry.
- Excellent writing skills, meticulous attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data.

Bonus Points! Otherwise Known As Preferred Qualifications:

- PharmD or PhD preferred

GET HIRED, APPLY NOW!

RECRUITER: Tonya Allen

Yoh, a DayJ2W: HC

J2W: PROF

MONJOBJ2WNECLIN

Ref:

SFSF: LS