Associate Director of Medical Writing

Expanding global pharmaceutical company is seeking an Associate Director of Regulatory Medical Writing in Chicago, IL. Salary level is from $140-$200k/year depending on experience and number of direct reports. Work from home is available 2 days a week, 401k match is up to 6%, bonus is 15-20% with the chance to double depending on company and personal performance, vacation starts at 4 weeks and more! Responsibilities: - Development and management of direct reports and outsourcing plans for medical writing in assigned product areas - Co-develop the strategy for document preparation, SOPs, and guideline documents including time frames that meet or exceed company standards and the document review processes - Prepare content templates for clinical documents that are consistent with FDA and ICH guidelines and with electronic submission guidelines - Leading Phase I-IV clinical and regulatory documents and submissions, including IBs, CSRs, integrated summaries of efficacy and safety, registration dossiers, package inserts, briefing books, and responses to health authorities - Manage, train, mentor and work closely with other writers (direct reports or contractors) - Preparation of presentations for major external meetings Requirements: -MS, MD, PhD preferred, Min of BS -At least 7 years of regulatory writing experience required -Ability to analyze industry trends for study reports and international dossier preparation, including electronic document submissions (eCTD), and synthesize standardized solutions -Extensive experience writing all types of clinical & regulatory documents and with registration dossiers for worldwide use -Knowledgeable in preclinical development including discovery, toxicology etc. -Experience working with CROs Don't miss out on the opportunity to further your career - contact me today to find out more! Many management positions are open to expand to other geographies in the future as well as various levels! Send resumes to Dandan Zhu at Real Pharma at 212-707-8499 and please call to make sure I received your application.

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com