Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:
Provides experienced strategic, 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.

Essential Functions:

• Provides expertise in client submission deliverables supporting regulatory compliance.
• Prepares components of electronic regulatory submissions that meet the electronic document requirements set by regulatory guidance, publishing documents and submissions that work with sponsor and/or regulatory agency software programs, and meeting consistency and security issues, under general supervision of the Manager, Electronic Publishing.
• Maintains document life cycle for submission documents.
• Leads the development and implementation of project-specific processes for sponsors with unique technology requirements.
• May act as the company's liaison for regulatory submission with the sponsor and assist the company's project teams in executing regulatory submission strategies.
• Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel, as needed.
• Uses professional judgment to evaluate 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 or as the project team lead to evaluate and deliver publishing tasks.

• Strong knowledge of regulatory requirements and guidance for document management and electronic submissions
• Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools
• Advanced knowledge of electronic templates and skilled in formatting and troubleshooting templates.
• Ability to manage several complex projects in parallel and adapt to changing priorities
• Ability 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 deliverables
• Ability to independently learn new technologies
• Advanced organizational skills and effective interpersonal skills
• Advanced analytical ability and problem-solving capabilities
• Strong knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies
• Advanced editorial/proofreading skills
• Detail-oriented, thorough, and methodical
• Ability to create and follow timelines and conduct long-range planning
• Ability to multi task performing numerous single or complex tasks without ignoring overall objectives
• Ability to judge when to initiate changes and make final determinations in the presentation of data in accordance with regulatory guidelines and reviewers' comments
• Ability to concentrate on the detail in a document without losing sight of the document as a whole