"Alerted.org

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Publishing Specialist – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to provide moderate, expedient, and efficient preparation of client electronic submission deliverables and dossiers that meet current local, regional, and ICH regulatory and technical requirements. As a Regulatory Publishing Specialist, you'll ensure successful regulatory review outcomes for product milestones. Serving in a quality review role, you will be responsible for the thorough review of documents created within or outside of the company to ensure quality standards meet or exceed client expectations

What You’ll Do:

• Coordinates and manages client 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 security issues.

• 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.

• 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.

• Exercises judgment within 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 within a project team to evaluate and deliver publishing tasks

Education and Experience Requirements:

• 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 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 inaccordance with regulatory guidelines and reviewers’ comments

• Ability to concentrate on the detail in a document without losing sight of the document as a whole

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.