Regulatory Project Manager to AstraZeneca in Mölndal!
Adecco Sweden AB / Undersköterskejobb / Mölndal
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hela Sverige AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world 's most serious diseases. But we 're more than one of the world 's leading pharmaceutical companies. At AstraZeneca, we 're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
This consultant assignment, which is placed in Mölndal, is planned to start at the end of august and proceed for twelve months.
The arena
The Regulatory Project Management (RPM) group sits within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organisation and is accountable for end to end regulatory project delivery, providing regulatory expertise, efficient project management and strong leadership in line with business priorities.
We now have the opportunity for two-three individuals to join our team in the role as Regulatory Project Managers (RPMs) within the RPM RIA, Inf & Vacc team, and the RPM CVMD & NS team in Gothenburg. The roles are on a temporary basis for one year.
The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Accountabilities/Responsibilities:
• Monitor and interpret the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverables.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work.
• Lead and / or contribute to the planning, preparation and delivery of simple and with experience, increasingly more complex submissions throughout the product 's life cycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, Trial Master File (TMF), and document management utilizing the support and input of Global Regulatory Operations , Marketing Companies, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RPM skill group.
• Contribute to process improvement.
Preferred Experience
• Relevant University Degree in Science or related discipline
• Minimum one year 's experience of managing regulatory work
• General knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams
• Excellent written and verbal communication skills
• Influencing and stakeholder management skills
• Continuous improvement and knowledge sharing focused
What do we offer?
Adecco Life Science is a specialized Business Line within Adecco. We work exclusively with Staffing Services and Recruitment of personnel within the Life Science industry. Our expertise lies within all areas of Life Science such as R&D, Production, Quality Assurance, Clinical Research, Regulatory Affairs, Medical Affairs, Marketing & Sales and many more. Our customers are companies, of different sizes, within the Pharmaceutical-, Biotech- and Medtech- industries. As the largest recruiting and staffing company in the world our most valuable assets are our consultants. With us, you as a consultant will be appreciated for your difference-making competence within Life Science!
Adecco Life Science can offer you the opportunity of interesting assignments and positions at attractive companies that perhaps never will be put out on the open market! For your security as a consultant, you are covered by our collective agreement and by insurance and corporate healthcare. We also want you to stay healthy and therefore offer you healthcare contributions and discounts on training cards. We arrange social activities continuously where you are able to share your experiences with our other consultants.
Are you interested?
Then you should apply as soon as possible. Last day for applying is august 15th. The position is soon to be filled and therefore work with recruitment is being done on a continual basis.
Unfortunately we cannot accept applications through e-mail, but if you have questions regarding the position contact Nalin Yilmaz,
nalin.yilmaz@adecco.seWe look forward to your application!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-07-17ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-08-15
Klicka på denna länk för att göra din ansökanKontaktNalin Yilmaz
nalin.yilmaz@adecco.seFöretagAdecco Sweden AB
AdressAdecco Sweden AB
Kungsgatan 60
10224 STOCKHOLM
KontorsadressKungsgatan 60
Jobbnummer 3607286
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