Clinical Medical Writer Supervisor- Pharmaceutical - Austin

Our client, a CRO located in Austin, Texas, is seeking an experienced Clinical Medical Writer with supervisory experience. They are experiencing exciting growth and are a leader in the industry, as the flagship company of a global CRO organization. They are committed to providing outstanding service to their clients as well as an exceptional environment for their employees.  If you are interested in joining a dynamic, winning team, this is your opportunity.Technical Specifications and Responsibilities include ·  Generate concise and comprehensive clinical protocols through integrating information obtained from proposals, protocol outlines, sponsor correspondence, published literature, and prescription drug monographs. ·  Integrate information obtained from protocols and sponsor correspondence to generate Case Report Form (CRF) templates. ·  Act as a mentor to the Assistant Medical Writer(s) and assist with compiling complete clinical study reports as needed. ·  Circulate documents prepared for quality control review and incorporate appropriate suggested changes from reviewers and sponsors. ·  Maintain organized system for tracking status of projects and meets deadlines. ·  Assist Document Coordination and Quality Assurance Departments with review of documents as needed. ·  Work with a team in developing and implementing new systems to handle the flow of documents. ·  Gather the information and feed back necessary to complete CRF templates, reports, protocols, amendments, administrative letters and memos by communicating with other departments (Project Management, Pharmacokinetics and Statistics, Marketing, Quality Control, Document Coordination, Coordinating Staff, etc.). ·  Identify inconsistencies and problems with study design by interpreting data and applying an understanding of company processes and data flow and provide assistance to clinic staff in order to refine study design.·  Verify that all materials/information needed to compile the report protocol are provided. If necessary, promptly notify appropriate personnel about need for additional information, material, or clarification. Requirements: ·  Advanced degree in science or a related field. ·  3+ years clinical trial work environment ·  3+ years experience writing protocols, regulatory documents, consent forms, and case report forms. ·  Working knowledge of GCP, FDA and ICH guidelines relating to conduct of clinical trials. ·  Able to work very independently and meet deadlines.  Our Client Provides Superior Benefits and Working Environment ·                    Health Benefits: Medical, Prescription Coverage, Vision and Dental·                    Paid Time Off·                    Paid Holidays·                    Child Care Assistance Program – on-site licensed day care·                    Cafeteria Plan/Section 125·                    Tuition Reimbursement·                    Credit Union·                    Notary Service·                    Retirement Savings – 401(k), Monthly profit sharing incentive plan·                    Life Insurance·                    A strong commitment offering its employees an exceptional work          environment with opportunities to grow professionally and financially. Compensation range is negotiable based on experience and starts at between $70,000 to $90,000 annually, plus bonuses.  For more information on this Direct Hire position, please contact Grant Simpson, Senior Recruiter, at 512-451-6213 or by email at grantsimpson@todays.com .