Associate Global Regulatory & Start Up Manager
Quintiles AB / Läkarjobb / Ospecificerad arbetsort
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hela Sverige Visa alla jobb hos Quintiles AB i Ospecificerad arbetsort Quintiles - world's leading Pharmaceutical Services Company is looking for Global Start up Lead, based in Sweden, to direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor's requirements, including pre-award activities, oversight of the scope of work, budget and resources.
Quintiles have operated in Sweden since 1996 and we have the experience and expertise to accelerate development of your compound and offer solutions to promote your products. We perform services from Phase II to Phase IV clinical trials.
RESPONSIBILITIES
The role holder may be required to cover all or some of the responsibilities mentioned below but will focus on selected activities at any one time, depending on business requirements.
• Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.
• Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Create and/or review core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
• Work with Quality Management to ensure appropriate quality standards for the duration of the project.
• Mentor and coach colleagues as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information .
• May take a lead role in developing long standing relationships with preferred Quintiles customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• In dept knowledge of clinical systems, procedures and corporate standard
• Good interpersonal skills, a strong team player
• Good regulatory and/or technical writing skills
• Thorough understanding of regulated clinical trial environment and knowledge of drug development process
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Proven ability to exercise independent judgment taking calculated risks when making decisions
• Good leadership skills, with ability to motivate, coach and mentor
• Good organizational and planning skills
• Good presentation skills
• Excellent understanding of study financial management
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Medical degree, with 7 years' relevant experience including demonstrable experience in acting as the main regional lead in studies or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods
• ?Potential for frequent travel.
For applying, please see the link:
https://quintiles.taleo.net/careersection/sweden/jobdetail.ftl?lang=en&job=1409260Publiceringsdatum2014-05-16Arbetstider och omfattningVisstidsanställning 6 månader eller längre
Heltid
ErsättningFast lön
FöretagQUINTILES AB
AdressQUINTILES AB
75323 UPPSALA
KontorsadressStrandbodgatan 1
Övriga kontaktuppgifterTelefonnummer: 018-4311000
Jobbnummer 1878363
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