Sr. Medical Writer for i3 Statprobe - Office- or Home-based Opportunity

UnitedHealth Group is an innovative leader in the health and well-being industry, serving more than 55 million Americans. Through our family of companies, we contribute outstanding clinical insight with consumer-friendly services and advanced technology to help people achieve optimal health.i3 Statprobe focuses exclusively on providing the pharmaceutical and biotechnology industries with comprehensive, integrated data service solutions that include data capture, summary, analysis, and reporting for clinical trials across all phases of research. The company demonstrates leadership and innovation by leveraging world-class process design and six-sigma quality, affording clients the ability to maximize efficiencies and exceed customer expectations. As a UnitedHealth Group company, i3 Statprobe is part of a worldwide health care service organization that uses innovation, integrity and commitment to prepare for the future - and you can prepare for yours with us. It's a rare combination for success that only a career with i3 Statprobe can provide.   i3 Statprobe is currently seeking a home- or office-based Sr. Medical Writer. The Sr. Medical Writer is responsible for planning, writing, and editing documents associated with research projects in compliance with regulatory guidelines and requirements.  The types of documents include clinical study reports (CSRs),  summary sections of regulatory submissions (NDA/CTD), protocols, manuscripts, slide kits, posters, etc. Responsibilities:   Develop CSRs,  using client or i3 Statprobe template Develop sections of CTD Module 2 and other types of documents in support of the regulatory approval process for pharmaceuticals, biologics, and devices Partners with external authors, internal Clinical Research Physicians, statisticians, other team members, and/or other writers to build balanced, scientifically based data disclosures and publication plans Plans, writes, reviews abstracts, posters/oral presentations, slides, and manuscripts Participates in publication planning and operations meetings Perform word processing using CSR template, or proof any word processing performed by the Word Processing Department Ensures and coordinates quality checks for accuracy, collates reviewers comments, and prepares final versions Quality Control review of documents Keeping i3 Statprobe and client reviewers informed of the date documents will be ready for review Complete review checklist to document that all relevant tasks have been performed Assemble CSR with appendices, per ICH guidance, or instructs Word Processing on assembly and checks the result Conducts literature searches Develops and drives detailed project timelines according to team-specified deadlines Continue development of professional skills and personal abilities to keep pace with regulatory guidances and dynamic needs of our clients Qualifications: Education: Bachelor's degree required; MS, MPh, PharmD, PhD, RN, or other advanced life sciences degree preferred.  Experience:Three to Five years experience in regulatory and commercial medical writing is required, as well as a demonstrated comprehensive knowledge of drug development process and regulatory guidelines.Diversity creates a healthier atmosphere: an equal opportunity employer. M/F/D/V.