Senior Associate, Regulatory Operations
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
We are currently recruiting for a Senior Associate, Regulatory Operations to work fully embedded with our pharmaceutical sponsor who is based in central London. In this role, you will be responsible for assembling content of submission per technical specifications and transmitting to the Regulatory Agency.
This role can be offered either as a 6 months fixed term or freelance contract.
* Able to independently format, publish, transmit and archive all submission types.
* Develop templates.
* Advanced understanding of regulations and guidances associated with submissions.
* Project Management and Communication
* Able to answer some technical questions for many submission types.
* Attend Regulatory Sub team meetings with main publishing contact to provide support.
* Able to answer most technical questions for many submission types.
* Able to troubleshoot and resolve some issues with critical computer application systems, e.g., MS Word and InSight Publisher.
* The candidate should have experience in Regulatory Operations and must be certified in InSight Publisher or be able to provide training completion certificates from Liquent.
* Basic computer skills in MS Office and Adobe Acrobat
* experience with scanners and copiers
* able to multi-task and set priorities
* pay close attention to details
* work in team environment
* Computer skills in InSight Publisher and Acrobat plug-ins such as ISI Toolbox, ability to publish routine submissions.
* Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions.
* Uses professional concepts and company's policies and procedures to solve a wide range of moderate problems in imaginative and practical ways.
* Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
* Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Application Details: If you have the required experience for this position and are eligible to work in the UK then please apply below or contact Ellie Zavrelova on +44 01628 408 455.
To find out more about our company and search and apply for other open jobs please visit our website http://www.inventivhealthclinical.com/job-opportunities.htm or https://www.incresearch.com/
Key words: Contract, Freelance, Regulatory Operations, Pharmaceutical, CRO, Hounslow, Chiswick, Turnham Green, Heston, Cranford, Ealing, Brentford, Hammersmith, Fulham, Earl's Court, Osterley Park, Richmond