Senior Medical Writer Job

Yoh has a long-term contract opportunity for a SENIOR MEDICAL WRITER to join our client in the Hackensack, NJ area.

Job Responsibilities

- The medical writer will work directly with clinical study teams, the Neuroscience medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
- Prepare regulatory documents in accordance to 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, addenda, errata. Investigator brochures, new drug advisory submission documents.
- Participate in clinical study and project team meetings to provide input regarding deliverables, timelines, and processes needed.
- Administer the receipt, collation, and incorporation of review documents. Route documents for approval.
- The medical writer should be familiar with ICH guidelines and the AMA Manual of Style, 10th edition because the medical writer will be asked to format and manage long documents with multiple review cycles and tight deadlines.

Job Qualifications:

- Master's degree in life sciences, PharmD or MD and seven (7) years' writing experience in the pharmaceutical industry.
- Excellent writer, good organizational and communication skills. Strong attention to detail.
- Proficiency using Edms.
- Strong analytical ability to interpret clinical data.
- Excellent writing skills, compulsive attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data.
- Must be able to work onsite 3 days a week to be considered.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: TONYA ALLEN

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOB J2WNECLIN

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SFSF: LS