Company: Worldwide Clinical Trials
Location: Nottingham, Rome, Serbia, Bulgaria
Closing Date: 12 Nov 16
Salary (£): On Application
We currently have 2 vacancies on a 12 month fixed term contract to Support the Trial Technologies team. The role can be office based in Rome, Serbia, Bulgaria or Nottingham United Kingdom. The Support Assistant\Manager is responsible for administrating the successful implementation of DocuSign and the support of ongoing DocuSign developments. Responsibilities encompass performing daily administrative tasks and providing second-line support to users.
Tasks may include but are not limited to:
•Take ownership of support tickets related to but not limited to DocuSign. Including supporting issues or requests and the closure of support tickets within SLA timeframes.
•Liaise with WCT business departments who use DocuSign to fully understand their current requirements and future needs.
•Supporting\creating DocuSign templates in an efficient and accurate manner, and ensuring these templates get appropriate review and sign-off when required
•Provide additional training on DocuSign to employees when required
•Undertaking additional office duties as required by the Trial Technologies Department
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
•Attention to detail is a must
•Task orientated, capable of taking ownership of incidents from the moment they are received until resolution
•Knowledge of DocuSign and SharePoint would be an advantage
•Excellent communication and interpersonal skills
•Excellent listening skills and the ability to empathize
•Flexible, adaptable and able to work under pressure
•Ability to set and meet deadlines
•Attention to detail in work performed
•Able to succeed and contribute to a team environment
•Perfect command of English (written/oral).
•Customer Service Experience
•Educated to A level or relevant experience (UK)
•Educated to completing graduation of High School or equivalent (US)
Worldwide Clinical Trials (WCT) currently have a permanent vacancy to support activities due to new projects. Experience in Global submission is required.
*Must be Spanish national with Spanish ID* Residence in Spain is not mandatory.
Senior Regulatory Specialist,, Global Regulatory Affairs, Senior Regulatory Associate. Regulatory Affairs Specialist.
Company: Worldwide Clinical Trials Ltd
Location: Home based (any country)
Closing Date: 29 Jul 16
Salary (£): On Application
Benefits: Bonus + benefits
Job summary: Exciting opportunity within a leader global CRO which provides full drug development services to the pharmaceutical and biotechnology industries from Early Phase and Bioanalytical Sciences through Phase II and III trials to peri-approval studies. The company is looking for a Senior Specialist or Manager Regulatory Affairs to join their expanding Clinical Study Start-Up and Regulatory Affairs group.
Full-time permanent position for a Senior Specialist or Manager who will provide regulatory oversight to clinical studies awarded to Worldwide across regions for all stages of the drug development cycle (from phase I to IV) and will ensure the smooth running of the Regulatory Affairs activities within studies.
•Effectively and rapidly coordinate & manage CTA submissions to regulatory authorities and ethics committees and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
•Ensure high quality performance of deliverables are applied within the projects assigned and promptly identify and address any risk/potential risk by implementing preventive measures
•Provide regulatory strategic advice to internal and external customers
•Contribute towards the preparation and/or review of technical documentation (i.e. protocol, IMPDs and IBs) when required
•Review and, if applicable, customise all relevant documentation (i.e. labels, patient information sheets, diary cards, insurance etc) to ensure high level of quality and compliance with ICH GCP & country specific requirements
•Assist RA-BIDs and senior management in securing new business or repeated business by participating to BDMs, developing/ reviewing regulatory sections of proposals and regulatory costing and budgets
•Provide coaching, advice and mentoring to regulatory members assigned to the projects (although the position will not have any direct line management responsibilities)
SKILLS AND EXPERIENCE:
•Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
•Minimum 7 years within pharmaceutical/CRO industry, of which at least 5 years as regulatory lead in global clinical trials
•Proven ability to successfully manage global projects in start-up
•Excellent organizational and management skills
•Outstanding written and verbal communication skills and interpersonal skills
•Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment
•Ability to exercise sound judgment and make decisions independently
•Expert knowledge of ICH GCP and the EU Clinical Trials Directive/Regulation and National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
•Expert knowledge of drug development
The successful candidate must be a Spanish citizen with a valid national ID. Residence in Spain is not mandatory.
Due to the volume of applications, we regret that we can only respond to successful candidates.
Worldwide Clinical Trials
2nd Floor 172 Tottenham Court Road London
|Tel:||0207 121 61 61|
|Website:||Visit Our Web Site|
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