Sr. Dossier Management Associate

Are you looking for a career in a collaborative innovative environment filled with passionate talented people, who are dedicated to changing the practice of medicine? Our Client is a leading biopharmaceutical company with its research, development and commercialization activities focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, their understanding of disease mechanisms, and their industrialized drug discovery platform, the company is seeking to develop breakthrough products.  Our Client was recently acquired by one of the largest global leaders in the industry! The two companies, now merged as one, are committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.They will continue their commitment to developing breakthrough medicines that will benefit patients around the world. They are excited to serve as a global center for oncology as they work to drive scientific excellence and create a world-class pipeline and products. The value of their focus on disease pathways is illustrated by the pipeline of potential drugs they have in clinical development, which includes molecules targeted to several key pathways: the ubiquitin-proteasome pathway, leukocyte activation and migration, and kinase-mediated signaling. Over the last decade, this combination has made our client the partner of choice for many major pharmaceutical companies seeking to enhance their R&D productivity. A career with our client comes with benefits that few companies can match.  They believe that everyone should have a great career and a great life, both on the job and after hours. Their compensation and benefits package are structured to help employees make meaningful contributions at work, and enjoy their free time to the fullest! Sr. Dossier Management AssociateThe Dossier Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Dossier Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, overseeing publication activities, and utilizing a wide array of document management, authoring, and publishing tools. The Dossier Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability. Working closely with the Regulatory Leads, the Dossier Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management. Responsibilities: Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management Identify issues that may delay product or project and recommend appropriate action Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity Prepare and maintain templates that meet Regulatory electronic submission standards Assist in establishing electronic submission capability at Millennium, focusing on implementing the eCTD and representing Regulatory business function on technology teams Manage compliance-related submissions and activities Knowledge and Skills: Minimum of 4 years of experience within the pharmaceutical industry and strong project management and/or submission management experience is required Skill in using desktop applications and proficiency in computer systems and procedures is required Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired 4 years Regulatory Affairs or pharmaceutical experience is required Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired  MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Boston, MA 02101 JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: EB-1284110298 COMPANY: Dennis Partners