Submissions Manager Job in Weybridge, Southern UK

 

We currently have an exciting opportunity for a Submissions Manager within our Regulatory Affairs department based in our Weybridge site.

KEY RESPONSIBILITIES INCLUDE:

 

·          Responsible for publishing activities and resource management of all assigned submissions/reports/documents in compliance with internal and external formatting standards.  It is expected that incumbent of this role will be required to manage delivery of the less complex submissions whilst growing publishing skills, as required by the Global Submissions Manager.

·          Works in a collaborative effort with regional (local) and global (trans-Atlantic) peers to ensure assigned submission work is accomplished to agreed timings;

·          Implement publishing plans as organized by Global Submission Manager(s) in co-ordination with departmental submissions deadlines;

·          Schedules regional work on dossiers and study reports in order to meet agreed regulatory targets.  Establishes, maintains and monitors plans that reflect or impact publishing production.  Work may be self-prioritized or may come from a more senior-level person in the group as part of a larger work plan;

·          Develops good working relationships with internal and external customers in an attempt to facilitate effective communication and to ensure that customers are aware of their impacts on the submission assembly and publication process;

·          Act as interface between customers and their regional Submissions group to resolve issues.  Advice/intervention from more senior-level person(s) may be required until a high level of competence/confidence is attained;

·          Coordinates directly with Regulatory Affairs functions - both central and globally (i.e., country managers), to provide registration dossiers suitable for rapid submission to regulatory authorities;

·          Provides advice and guidance on the production and publishing of regulatory submissions to RD project teams.  Proactively participates in project team meetings and helps to define the process of collecting data/documents and building submissions. 

 

DIMENSIONS OF THE ROLE:

 

Basic Qualifications:

 

The ideal candidate for the position of Regulatory Operations Submission Associate would possess the following qualifications:

·          Must have a Bachelor’s degree in a Life Science, Computer Science or other related discipline or equivalent experience

·          Must have regulatory document management experience or Information Technology experience with emphasis in document/data management, submission/report publishing and involvement with regulatory and/or IT-related projects.

·          Experience with at least one large submission or several smaller submissions is preferred;

·          Must have experience in managing multiple submission projects;

·          Must have a proven awareness and ability to work within areas of cultural differences;

·          Must have a proactive attitude towards project management and process improvement;

·          Must be able to foresee and solve problems, in a strategic manner, typically encountered during dossier compilation and production;

·          Must have a demonstrated ability for working within large or small multidisciplinary teams.

The Submission Associate will be required to have and demonstrate specialized knowledge in the following areas:

·          Basic knowledge in format and content of Regulatory submissions.

·          Basic knowledge in the format and creation of eCTD and NeeS dossiers.

·          Basic knowledge of electronic document management systems and the techniques for managing documents within these systems from creation through approval/issuance.

·          Aptitude or experience in developing effective working relationships with data generators, report writers, project and submission teams.

·          Knowledge of how documents are assembled into Regulatory submissions.

·          Basic knowledge of software used for publishing Regulatory dossiers/complex reports from within an electronic document management system.

·          A general understanding of the process by which RD develops a new product and the interactions between the various functional areas within RD.

·          Able to thrive and operate effectively in a rapidly changing environment, where submissions guidelines and departmental standards and processes are continually evolving

Preferred Skills

 

·          A post graduate degree in science related discipline

·          Prior work experience within a consumer healthcare organization

 

Behavioral Requirements

 

Detail Oriented

Excellent communication skills

Drive Innovation

Teamwork

Organizational skills

Technical/Professional knowledge

 

 

To Apply:

 

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

 

For confidential consideration and efficient processing, please apply online via GSK’s online application system by clicking on the Apply link below:

 
http://careers.peopleclick.com/careerscp/client_gsk/external_pages_uk/gateway.do?functionName=applyFromLinksource=MONSTERjobPostID=184861locale=en-ussourceType=PROF_WEB_COMMUNITYQID

 

Thank you for taking the time and effort to apply for this role. All data processed in accordance with the provisions of the Data Protection Act.

 

GSK is an equal opportunities employer and is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. To enable GSK to meet its commitment as a two ticks employer please let us know if you have a disability.