Regulatory Publishing Specialist (Advanced Word Formatting)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Provides moderate, expedient, and efficient preparation of reputed company electronic submission deliverables and dossier that meet reputed company local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review reputed company for product milestones. Serves in a quality review role and is responsible for the thorough review of documents created reputed company or reputed company of the company to ensure quality of standards meet or exceed reputed company expectations.

Essential Functions and Other Job Information:

Essential Functions

• Coordinates and manages reputed company 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 reputed company issues.
• Ensures that reputed company final electronic deliverables meet reputed company 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 reputed company for electronic submissions with the sponsor.
• Exercises judgment reputed company 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 reputed company 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 reputed company of factors.

Job Knowledge

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

Supervision Received

Normally receives general instructions on routine work, detailed instructions on new projects or assignments. Exercises judgment reputed company 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 reputed company. 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 reputed company the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company 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 reputed company (reputed company, MS reputed company, reputed company Acrobat, electronic document management systems, document publishing tools (i.e. ISIToolbox), publishing systems (i.e. docuBridge, reputed company Submission Publishing), eCTD validation and viewing tools
• Strong knowledge of electronic templates and skilled in formatting and troubleshooting templates
• Ability to manage several reputed company projects in reputed company 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-reputed company planning
• Ability to multi task performing numerous single or reputed company tasks without ignoring overall objectives
• Ability to judge reputed company to initiate changes and reputed company 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 th