Senior Scientific Medical Writer Whippany, NJ

Senior Scientific Medical Writer

 

 

Job ID: Job-2745

location:       Whippany, NJ

Jobtype:        Permanent

Rate:   $110K - $130K

       

Description:   

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Act as the medical writing expert responsible for research, writing and editing of study level and submission level documents. Provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities  include assuring quality and timely preparation of clinical documents across all therapeutic areas as assigned, including clinical study reports, clinical study protocols, investigator's brochures, clinical summaries and overviews.

 

REQUIREMENTS:

 

• Bachelor's degree or equivalent with at least 6 years of experience in the pharmaceutical industry in total, including a minimum of 5 years in Medical Writing and demonstrated working knowledge of scientific principles. OR a Master's degree or equivalent with at least 4 years of experience in the pharmaceutical industry in total, including a minimum of 4 years in Medical Writing and demonstrated working knowledge of scientific principles. OR PhD degree or equivalent with at least 3-4 years of experience in the pharmaceutical industry in total, including a minimum of 3 years in Medical Writing and demonstrated working knowledge of scientific principles

• Must have experience developing clinical documents in support of regulatory submissions globally (ie: multiple regions) in more than one therapeutic area

• In depth understanding of all regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (eg ICH, FDA, EMEA)

• Experience with electronic document management and electronic regulatory submissions, tools and standards

• The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas

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Email resume in Word to JeffAltman@TheBigGameHunter.us. Please include the job code for the position with your resume. NOTE: WE WILL ONLY RESPOND IF YOUR RESUME APPEARS TO FIT A ROLE

 

NO PAID RELOCATION. NO OVERSEAS RESUMES. NO 3RD PARTIES. Applicants for employment in the US must possess work authorization which does not require sponsorship from the employer for a visa.

 

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