1+ months

Medical Writer

Altria
Richmond, VA 23261
17903BRPosition Title:Medical WriterRequisition Number:17903BRCity:RichmondJob Description:We are currently seeking a Medical Writer in our Regulatory Affairs organization in Richmond, VA. The Medical Writer will communicate complex scientific information in clear and compliant written communications to ensure successful preparation of high quality documents for FDA product applications and submissions. Specific accountabilities include: Coordinating with various subject matter experts (SME) to gather, organize and present scientific information on new products for regulatory applications and submissions primarily to the Food and Drug Administration (FDA).Assessing data on products and processes for regulatory applications and submissions, primarily to the FDA.Developing clear and effective communications of scientific information received from SMEs and literature searches and reviews for FDA regulatory applications and submissions.Conducting comprehensive literature searches and reviewing and analyzing relevant literature to summarize appropriately for FDA regulatory applications and submissions.Editing communications to incorporate management, SME and other reviewer comments.Conducting scientific/technical review of material prepared by other scientists to include abstracts, protocols and study reports.Specific Skills:Qualifications include: Masters in engineering or a science field including but not limited to toxicology, psychology, chemistry and clinical research. PhD preferred.8+ years of relevant experience.5+ years medical or scientific writing experience; Experience preparing Investigational New Drug (IND), New Drug Application (NDA) or Premarket Approval (PMA) submissions preferred. Excellent interpersonal skills, analytical and critical thinking.Strong project management and organizational skills and proven ability to meet timelines.Strong communication skills, proficient command of the English language in both oral and written format, and action orientation to address issues.Proficient with Microsoft Office applications, Adobe Acrobat, Reference Manager and other related technology tools Altria is a Fortune 200 company, proud to call Richmond, Virginia our home. Our companies which have been the undisputed market leaders in the U.S. tobacco industry for decades include some of the most enduring names in American business: Philip Morris USA, the maker of Marlboro cigarettes, and U.S. Smokeless Tobacco Company, the maker of Copenhagen and Skoal. We also own John Middleton, manufacturer of Black & Mild cigars, Nat Sherman, a super-premium cigarette and cigar business and Nu Mark, an innovation company which makes e-vapor products like Mark Ten. We complement our total tobacco platform with Ste. Michelle Wine Estates, a collection of distinctive wine estates and maker of Chateau Ste. Michelle, and our significant equity investment in Anheuser-Busch InBev the world's largest brewer. Altria aspires to be the U.S. leader in authorized, non-combustible, reduced risk products. (Learn more at Altria.com) Our approach to regulatory advocacy relies on deep scientific expertise, understanding of consumers and effective engagement and collaboration with regulatory agencies. Fueled by our strong core tobacco business, we've been concentrating on new product platforms. These include oral nicotine containing products, E-Vapor, and heated tobacco products.We believe these platforms have potential to drive adult smoker conversion. We can only compete in the marketplace with products authorized by the FDA and we can only communicate reduced risk claims with FDA authorization. We plan to file a number of regulatory applications in the coming years. As existing products continue to improve, new products become available, and the FDA authorizes manufacturers to communicate accurate risk information, we believe adult smoker conversion will accelerate. This will be a win for adult tobacco consumers, for public health and for our long-term commercial success.In addition to the opportunity to apply and develop your skills toward key business objectives, we offer an excellent compensation package including a competitive base salary, comprehensive health/vision/dental insurance, participation in our deferred profit sharing and incentive compensation programs as well as a relocation.State:VirginiaNOTE*:Each Altria company is an equal opportunity employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, sexual orientation, disability, gender identity, protected veteran status, or other protected class. Sub-Function:Regulatory AffairsCompany Name:Altria Client Services

Categories

Posted: 2018-05-18 Expires: 2018-11-14

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Medical Writer

Altria
Richmond, VA 23261

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast