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9 days old

REMOTE Regulatory Operations Manager

Kelly Services
Gaithersburg, MD 20898 Work Remotely
**Kelly Services** is currently seeking a REMOTE **Regulatory Operation Manager** to work a contract assignment 6 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities includes:**



The Regulatory Operations Manager (ROM) is responsible for end-to-end document and submission publishing, which includes planning, compiling, publishing, delivering and archiving of regulatory submissions. ROM coordinates printing and distribution of both paper and electronic submissions to all markets within agreed timelines and quality standards.



Responsible for handling Clinical and Patient Safety information according to the GRO Service Level Agreement and provides document management guidance to users working with Clinical and Patient Safety documents. The ROM is an expert in understanding Health Authority requirements as well as the regulatory requirements with regard to technical and formatting aspects of global regulatory submission publishing. Publishes relevant Clinical and Patient Safety deliverables to agreed submission-ready standards.





The ROM contributes to the enhancement of publishing processes.



Accountabilities:



**Publishing Delivery**




+ Provides expertise in management of Clinical/Patient Safety documentation and Clinical/Patient Safety submission components across each product lifecycle

+ Provides global expertise on requirements for electronic document management, submission compilation and publishing

+ Ensures that metadata is correctly applied so that documentation is retrievable and searchable within the company electronic document management system (EDMS)

+ Ensures regulatory documentation and submissions are compliant with health authority and/or company submission standards. Provides submission-ready standards guidance to members of global Clinical projects and study teams

+ Provides Clinical documentation publishing knowledge to Global Clinical project, submission and execution teams

+ Provides expertise in regard to procedural issues and contribute to setting and achieving realistic submission timelines in accordance to current standards, processes and GRO Service Level Agreement

+ Interacts with Regulatory Project Managers and Lead Dossier Managers/Dossier Managers to ensure submission deliverables, for example meet timelines

+ Provides training and support to project teams, external partners and stakeholders on topics related to document and submission/publishing management in accordance to the Operating Model

+ Shares knowledge and experience within GRO and contributes to establishment of best practices

+ Develops self in topic areas critical to successful delivery of the document and submission/publishing management remit, particularly, technical skills (electronic submission standards), knowledge of international regulations and organizational skills (communication, project management)

+ For document publishing plan and prioritise Clinical and Patient Safety submission deliverables (including outsourced deliverables) with Clinical Study Team Leaders and Regulatory Project Team Leaders in compliance with relevant company procedures

+ Contributes to planning of complex submission publishing activities such as large submissions with a considerable amount of data and to more than one market.





**Enablement**




+ Knowledgeable in ICH and Health Authority standards and requirements, and continuously share knowledge within company to ensure GRO processes are adapted to meet new requirements

+ Build relationships and participate in supporting and promoting Industry Working Groups and Agency electronic initiatives (according to our vision)

+ Take the lead to influence the strategy and efficient operation of GRO by challenging the current working processes and organization to meet the companys requirements for speed, quality and cost reductions

+ Have an in-depth knowledge about the Clinical and Regulatory external partner Alliances and collaborations and contribute to continuous improvements of collaborations and agreements

+ Contribute to enhancing business processes to maximise the effectiveness of GRO services and deliverables handled by external service providers

+ Be a subject matter expert (SME) and represent GRO in relevant crossfunctional networks

+ May take on the role of ANGEL Business Administrator (ABS) or other roles in the Submission Publishing Governance structure as appropriate

+ Drive and contribute to the improvement, efficiencies and implementation of tools, methodologies and processes within regional and global teams. Participate in the development of processes, policies, guidelines, SOPs & training materials and sharing best practices



Monitors the environment for changes in legislation related to Regulatory eSubmission -ReQureiments (ReSQ). Reviews and evaluates regulations, guidelines and technical specifications related to submission/publishing processes. Provides global expertise on requirements for electronic document management, submission compilation and publishing



Requirements:




+ University degree or equivalent experience in life sciences or technical field

+ Demonstrated ability to work in accordance with processes

+ Demonstrated ability to work collaboratively in a global team environment and to have good project management skills

+ Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment

+ Comprehensive knowledge of Microsoft Office and Adobe Acrobat applications

+ Excellent English written and verbal communication skills.





Preferred:




+ Experience of system administration for validated applications within a regulated environment

+ Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions

+ Experience as document and submission publisher including knowledge of regulatory publishing tools (e.g., eCTDXpress, FirstDoc, ISIToolBox)

+ Knowledge of company submission compilation, publishing, approval processes, tools and standards

+ Ability to thrive in a rapid paced environment

+ Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business

+ Good problem and conflict resolution skills.



**APPLY NOW!**



**For immediate consideration,please send your resume in a WORD document to gaut985@kellyservices.com**




**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

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Posted: 2020-10-12 Expires: 2020-11-12

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REMOTE Regulatory Operations Manager

Kelly Services
Gaithersburg, MD 20898

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