Translations and Dossier Excellence Manager in Sandwich

Recruiter
CK Clinical
Location
Kent
Posted
12 Oct 2018
Closes
14 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Jenni Woolley at CK Group is recruiting for a Translations and Dossier Excellence Manager to join a company in the Pharmaceutical industry at their site based in Sandwich on a 6 month contract basis. The successful candidate will be joining the Submissions Management team in Worldwide Safety & Regulatory.Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.This role will be based in Sandwich, home to their only automated 'pilot plant' that manufactures medicines for use in clinical trials worldwide . There, they are able to perform every step in the complex process of producing a new medicine. Sandwich sits in the district of Dover in Kent, south-east England. The larger towns of Canterbury, Deal, Dover and Thanet are within easy reach by road and rail. The Role:As a Translations and Dossier Excellence Manager you will network with WSR colleagues across locations, manages contract /project and / or vendor resources as appropriate and work with key internal interfaces; Finance, Procurement, and other relevant WRD stakeholders. The purpose of the position is to:· To drive process standardization, excellence and change specifically related to Submission Management, whether driven by improvement or change in operating model; capturing and analyzing areas for improvement and implementing remedial action on designated business processes. · To set and promote the framework for inspection readiness with regard to submission processes, and to champion compliance with internal requirements and external regulations.· The emphasis of this role is overseeing performance of submission / dossier processes across multiple regions and/or HQ. Management of business performance is global, cross-regional and/or within region in line with priority business need. · To monitor delivery of expected process efficiency and identify opportunities for enhancements based on metrics and stakeholder feedback. · This role operates as primary point of contact for dossier and translations excellence, working across multiple functions and may represent the line on multiple change projects in this capacity.Your Background:To be successful in this role you should be have experience, knowledge and skills in the following areas:· Demonstrated ability to lead, influence and operate seamlessly across the organization ensuring timely and quality delivery of projects that meet evolving business needs, demonstrating attention to detail.· Demonstrated ability to understand and conduct data analytics, trending and result delivery, inclusive of issue resolutions.· Ability to communicate complex business information and analyses to a variety of audiences in both verbal and written format, across various cultures.· Ability to meeting the expectations and requirements of key internal and external stakeholders, establishing and maintaining effective relationships, gaining trust and respect.· Ability to provide expert input to respond directly or indirectly to new business questions from key internal and external stakeholders. · Demonstrated business acumen; strong organizational management skills, the ability to manage multiple demands simultaneously; the ability to respond to tight timelines in a highly regulated environment.· Demonstrated experience and proven success in process design and development.· Proven experience to effectively handle multiple and diverse business support work assignments under pressure.· Ability to effectively cope with change.· Strong knowledge of the drug development process, regulatory affairs, and operations.· In-depth understanding of systems and electronic technologies used to support submission and planning activities.· Knowledge of relevant business systems, processes, information and technical tools and skills. · Understanding of systems such as document management systems, milestone reporting tools, and other electronic technologies. · B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43643 in all correspondence.

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