Manager Electronic Publishing

At MRINetwork Management Recruiters International - The Merwin Group, we specialize in the placement of outstanding talent in the biotechnology industry, combining a proven, targeted methodology and individual industry expertise to match the best candidates with the right companies. Our client, a leading biotechnology company with a focus on infectious disease and cancer, has a strong pipeline of drug candidates and partners with some of the biggest names in the industry. The Manager of Electronic Submissions opportunity is responsible for project managing electronic submissions to regulatory agencies, domestic and international. If you are motivated for a challenging and rewarding opportunity, we would like to assist in determining if this opportunity or many of our other searches match with your expectations, background and experience. Essential Duties & Responsibilities  Project manage compilation of large marketing applications, such as eCTDs, BLAs, etc. Compiles and submits submissions to regulatory agencies, both domestic and international Creates and manages document templates for regulatory documents and submissions. Supervises the tracking and ordering of submission and equipment supplies Assists with the creation, editing & revision of SOPs, Working Practices and Instructions. Required Skills, Experience and Keys to Success  Familiarity with drug development process, FDA and ICH guidelines. Familiarity with regulatory submission process and application types for US, Canada, and EU. Advanced knowledge of EDMS and regulatory publishing applications, as well as MS Office applications and Adobe Acrobat Excellent project management and organizational skills. MS Project skills a plus. Demonstrated ability to work independently and in collaborative team environment College Degree or equivalent.  MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Rockville, MD JOB CATEGORY: Medical/Health TYPE: Full Time, Employee JOB REFCODE: 2294 COMPANY: The Merwin Group CONTACT NAME: Natalie Woloshyn PHONE: 215-283-1800 x 107 EMAIL: Apply by Email