Reg Publishing Spec

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Provides 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.

Essential Functions:

1. Coordinates and manages client electronic submission deliverables supporting regulatory compliance.
2. 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.
3. 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.
4. 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.
5. Exercises judgment within defined procedures and practices to determine appropriate action.
6. Evaluates the publishing needs in relationship to the overall project timelines, quality and delivery.
7. 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.
8. Acts independently within a project team to evaluate and deliver publishing tasks.

Job Complexity:

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

Job Knowledge:

Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

Supervision Received:

Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment within defined procedures and practices to determine appropriate action.

Business Relationships:

Contacts are primarily internal to the company with infrequent external customer/vendor contact on routine matters. Builds productive internal/external working relationships.

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 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 guidances 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 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.
• Strong organizational skills and effective interpersonal skills.
• 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.
• Ability to create and follow timelines and conduct long-range planning.
• Ability to multitask 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.

Management Role:

No management responsibility.

Working Conditions and Environment:

Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:

Ability to work in an upright and/or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.