Posted Mar 10
Real Staffing

Medical Writer- Regulatory-Clinical- WORK FROM HOME

Real Staffing
United States of America Full Time


New Jersey based Biopharmaceutical Corporation is seeking a Medical Writer to join them on a 1 year contract.

Duration: 1 year

Title: Medical Writer

Industry: Pharmaceutical

Location: Work from home/remote-client is based in New Jersey

Pre-requisites without any flexibility are listed below. Please do not apply if you do not meet the clients requirements mentioned. * Minimum of 12 years of "HANDS-ON" regulatory writing and submission experience is REQUIRED but 15 - 20 years is preferred.

* Experience must be within the pharmaceutical industry

Responsibilities will include, but are not limited to, the following: * Support development of clinical submission documents

Clinical Study Reports- CSRs

CTD summary documents (module 2.7)

Clinical Overviews (2.5); prepare and manage, create and/or review

* May need to lead submissions or new programs
* Respond to Health Authority questions as needed (eg, prepare response documents)
* Prepare IBs- Investigator Brochure's- and other documents to support clinical programs
* May be assigned to one or more documents and may have a lead or supportive role
* EDUCATION: 4 year degree required

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