Director of Medical Writing

Our client, a global, well-known pharmaceutical company, is seeking a Director of Medical Writing for their location in Morris County, NJ.  Compensation is up to $165,000, depending upon experience, along with a 30% bonus and an outstanding benefits package! 

To be considered for this role, you must have experience in managing and mentoring medical writers, and worked in the role as a lead or project level writer. You also need extensive knowledge and understating of all regulatory guidance, standards and requirements pertaining to global regulatory medical writing, such as ICH, FDA, EMEA.  Experience with tools and standards, electronic regulatory submissions, and electronic document management is also required.  Excellent communication skills, both written and verbal, are required to articulate concepts and ideas. You need to be diplomatic, and persuasive, and also be able to establish relationships with all key functional leaders and experts in the Global Development Organization.

Here’s what the job duties include (but are not limited to):

• Act as the Medical Writing TA expert and assume overall responsibility for directing the development (with input from appropriate expert functions) and implementation of the medical communication strategy for all regulatory submission documents for drug projects within the assigned TA(s).
• Support the Global Regulatory Strategist (GRS), Global Clinical Leader (GCL) in developing and maintaining all product strategy documents; then use these strategy documents to effectively drive the design of all associated clinical documents in support of the Global Clinical Development Plan (CDP), validate individual study protocol design and clinical study report (CSR) key messages, and provide key messages for all submission dossiers used to gain marketing approval.
• Work with the GCLs, GBLs and Clinical Standards groups, to develop project level data presentation and messaging standards in line with overall messaging strategy.
• Work with assigned Senior Medical Writers and Submission team experts (Global Medical Expert [GME], GCL, GRS, Global Drug Safety rep [GDS]) in developing and implementing the submission authoring strategy for all clinical sections.
• Work with GMW Regional Heads in developing and implementing authoring resource plans for all documents within the TA Stay current on all Regulatory Agency Medical Review guidelines and drug approval requirements for products within the assigned TAs.
• Mentor senior writers (internal and outsourced) in developing TA area Expertise.

 Here’s what you need to be considered for this role:

• Bachelor’s degree in a scientific discipline plus a minimum of 10 years experience in the pharmaceutical industry OR an advanced degree in science or business plus a minimum of 8 years experience in the pharmaceutical industry.
• Extensive experience (6+ years) in regulatory medical writing in the pharmaceutical industry involving all clinical document types including: Investigator Brochures, Clinical Study Protocols, Clinical Study Reports, Patient Narratives, and all clinical sections of Drug Submissions.
• Experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions) and in more than one therapeutic area is also required.