Director Medical Writing

Bracco Imaging SpA is one of the world leading companies in the imaging agent business, with products sold in over 80 countries and about 1,250 employees, around 300 of whom work in R&D, Medical and Regulatory Affairs. Bracco Imaging is headquartered in Milan, Italy.Bracco Imaging is a subsidiary of Bracco SpA, holding company of the Bracco Group, which also markets Ethical and OTC pharmaceutical products and Healthcare Services in Italy, as well as Advanced Medical Technology systems on a world wide basis, through the Bracco AMT companies, ACIST Medical Systems and Volume Interactions.For more information please go to http://www.bracco.comDuties and Responsibilities:•Directs the medical writing department/staff in the writing/rewriting, editing and preparation of manuscripts on clinical studies and scientific reports including special summaries from raw data for submission to the FDA or for in-company use, monographs, comprehensive reviews, scientific exhibits.•Manages the Central Product Information processes in reference to safety information including, but not limited to: the development/review of SPC’s, CDS’, PI’s, PSUR’s, EU ASR’s and the coherence between product labeling and CDS’s and adjunct safety information.•Manages vendor selection process for Phase I-IV WW clinical studies for any regulatory clinical document.•Develops and manages the RA budget with support and input from RA Senior Management.•Directs preparation and implementation of global policies, standard operating procedures, processes and standards.•Manages resource allocation and assures appropriate resources are available to meet objectives.•Develops and maintains lines of communication across Global MW, Drug Safety and Regulatory Affairs.Core Competencies:•Demonstrated medical writing skills and a high level of interpersonal skills to interact effectively in team and matrix work settings. Sensitivity to cultural differences.•Extensive knowledge of worldwide registration document requirements including ICH guidelines, EMEA requirements and FDA guidelines and requirements.•Demonstrated written/oral communication skills combined with supervisory and management skills. Able to manage and motivate a highly skilled professional staff.Education and/or Experience Required:•B.A/B.S. degree, advanced degree preferred.•7-10 years experience in regulatory writing or equivalent within the pharmaceutical industry, including supervising and managing a medical writing group.•Experience with medical imaging agents preferred.•Experience in filing applications for marketing authorizations in Europe and other ex-U.S. regions. Experience in Japan and China helpful.•Experience working with an electronic- based document management system. Other:•International travel, generally to European Countries required.We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.Education: Bachelor's Degree,Experience: 10+ yearsAdditional Information:Travel Percentage: 10%