Job Description

　　Regulatory Publishing Specialist

　　The Regulatory Publishing Specialist provides experienced moderate, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in a quality review role and is responsible for the thorough review of documents created within or outside of the company to ensure quality of standards meet or exceed client expectations

　　Major responsibilties:

　　Coordinates and manages client electronic submission deliverables supporting regulatory compliance. Assists in preparing electronic document outputs that meet requirements for regulatory publishing to include documents that work with sponsor and/or regulatory agency software programs meeting consistency and security issues. Ensures that all final electronic deliverables meet current regulatory electronic document requirements and guidance under general supervision of the Manager, Regulatory Publishing and assistance as appropriate from a Senior Regulatory Publishing Specialist. Assists with developing and implementing project-specific processes for sponsors with unique technology requirements and may act as the company's liaison for electronic submissions with the sponsor. Exercises judgment within defined procedures and practices to determine appropriate action. Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery.

　　Engages other project team members, functional units or publishing management as necessary to deliver final product and resolve/mitigate identified issues or barriers to delivery. Acts independently within a project team to evaluate and deliver publishing tasks.

　　Education and Experience:

　　Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

　　In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

　　Knowledge, Skills and Abilities:

　　Working knowledge of regulatory requirements and guidance's for document management and electronic submissions Strong knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates Ability to manage several complex projects in parallel and adapt to changing prioritiesAbility to exercise independent judgment in developing methods, techniques and evaluation of criteria using defined procedures and practices Ability to independently assess sponsor needs and work with project team members in producing compliant deliverablesAbility to independently learn new technologies Strong analytical ability and problem-solving capabilities Good working knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies Strong editorial/proofreading skills Detail-oriented, thorough, and methodical