Principal Regulatory Publishing Spec

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Ensures the on-time delivery of a quality product to the sponsor. Assists in the management of projects in the provision of regulatory publishing and submissions services. 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. Serves as liaison to internal

Essential Functions

• Prepares components of complex 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.
• Assists in the management of projects in the provision of regulatory publishing and submissions services.
• Acts as primary study contact or lead with internal and external clients.
• Provides leadership by participating in training, skill development, and mentoring of other regulatory publishing personnel, as needed.
• Assists in assessing sponsor needs and work with project team members in producing compliant deliverables.
• Serves in a quality review role thoroughly reviewing documents created within or outside of the company in order to ensure quality of a standard that meets or exceeds both client’s expectations and federal requirements

Qualifications:

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 8+ 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:

• • Ability to supervise, evaluate, and mentor departmental personnel
• • Ability to delegate tasks and facilitate completion of assignments
• • Demonstrated innovation in developing new ideas related to process improvements
• • Excellent knowledge of document management and electronic submissions
• • Excellent knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools, XML
• • Excellent knowledge of electronic templates and skilled in formatting and troubleshooting templates
• • Excellent organizational, analytical and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
• • Ability to independently assess sponsor needs and work with project team members in producing compliant deliverables
• • Ability to independently learn new technologies
• • Excellent editorial/proofreading skills
• • Ability to lead a diverse staff
• • Ability to train and mentor others