Regulatory Publishing Specialist (Advanced Word Formatting)

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company 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 reputed company review role and is responsible for the thorough review of documents created reputed company or reputed company of reputed company to ensure reputed company 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 reputed company as reputed company's reputed company for electronic submissions with the sponsor.
• Exercises judgment reputed company defined procedures and practices to determine appropriate reputed company.
• Evaluates the publishing needs in relationship to the overall project timelines, reputed company and delivery.
• Engages other project team members, functional reputed company 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 reputed company or assignments. Exercises judgment reputed company defined procedures and practices to determine appropriate reputed company. Business Relationships Contacts are primarily internal to reputed 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 reputed company / 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 reputed company in reputed company and adapt to changing priorities
• Ability to exercise independent judgment in developing reputed company, techniques and evaluation of reputed company 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 the document as a whole

Management Role: No management responsibility Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand reputed company of both hands with the ability to reputed company fast, reputed company, 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 reputed company and use a reputed company of computer software developed both in-house and off-reputed company.
• Ability to communicate information and reputed company so others will understand; with the ability to listen to and understand information and reputed company presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse reputed company.
• Performs a wide reputed company of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to reputed company under stress. Ability to multi-task.
• Regular and consistent attendance.

reputed company is an EEO/Affirmative reputed company Employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status. Apply tot his job Apply To this Job