Director of Medical Writing - Medical Writer Regulatory

Large pharmaceutical company is seeking a Director of Medical Writing to join the medical writing group and lead the in-house writers as well as the contract writers. This is an excellent opportunity to be an important member of this close-knit group that will offer the chance to participate heavily in life cycle management. Flexible work from home situations are available except during crunch times.

Salary is phenomenal, anywhere from $140k-$200k depending on experience and strength of potential. We are seeking motivated, friendly, sociable and experienced regulatory writers to promote growth and learning within the team.

Responsibilities:

-Prepare and contribute to writing documents for regulatory submissions such as NDAs, INDs, CSRs, IBs, ISS, ISE,COs, RMP, briefing books, summaries of efficacy and safety, dossiers, etc
-Managing contractors and mentoring in-house writers
-Work closely across functional teams to accomplish goals within the set deadlines
-Reviews DPP and SAP as needed
-Prepare budgets, establishes target dates for completion of assignments, establishes SOPs and quality standards for documents

Requirements:

-8+ years of solid medical writing experience in submission documents
-Submission or lead writer experience on complex documents REQUIRED
-Minimum of BS, advanced degree such as MS, PhD or Pharm D or BSN is preferred
-Excellent communication skills

This company offers excellent bonuses, quarterly rewards, strong benefits package, and relocation packages are provided as well. Do not miss this great chance to make a difference and be a treasured member of the team!

Apply today and send resumes to Dandan Zhu at 212-707-8499.To find out more about Real please visit www.realstaffing.com