Senior Regulatory Publishing Specialist - Cambridgeshire, United Kingdom - Thermo Fisher Scientific

Thermo Fisher Scientific

Verified Company

Cambridgeshire, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our colleagues in corporate strive for excellence in every task, at every moment.

We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

We are currently expanding our global Regulatory Publishing team and look to hire:

Senior Regulatory Publishing Specialist:

The Senior Regulatory Publishing Specialist provides experienced strategic, 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

Major responsibilties:

Provides expertise in client submission deliverables supporting regulatory compliance.
Prepares components of 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.
Maintains document life cycle for submission documents.
Leads the development and implementation of projectspecific processes for sponsors with unique technology requirements
May act as the company's liaison for regulatory submission with the sponsor and assist the company's project teams in executing regulatory submission strategies
Provides leadership by participating in training, skill development, and mentoring of other electronic submission personnel, as needed.
Uses professional judgment to evaluate 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 or as the project team lead to evaluate and deliver publishing tasks.

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 5+ 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:

Strong knowledge of regulatory requirements and guidances for document management and electronic submissions
Advanced knowledge of Microsoft (MS) Word, MS Excel, Adobe Acrobat, electronic document management systems, document publishing tools, publishing systems, eCTD validation and viewing tools
Advanced 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
Advanced organizational skills and effective interpersonal skills
Advanced analytical ability and problemsolving capabilities
Strong knowledge of medical terminology, statistical concepts, and guidelines and requirements of the FDA and other international regulatory agencies
Advanced editorial/proofreading skills
Detailoriented, thorough, and methodical
Ability to create and follow timelines and conduct longrange 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