Global Clinical Affairs Manager
Arjo AB Publ / Organisationsutvecklarjobb / Malmö
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Arjo is proud of having a strong focus on clinical knowledge and being able to demonstrate and communicate clinical value to our customers. As the Global Clinical Affairs Manager, you will be a crucial part of this as the Clinical subject matter expert. You will work in a very interesting cross-functional environment with tasks ranging the full spectrum from early product ideas and new product development to follow up on how our products help customers and patients once they on the market.
Do you want to be part of a passionate team? We offer you an important role in a growing world-leading medical technology company where you will work with products that provide a very high value. The role is based in Malmö but you will be part of an international team so the role requires global travel.
The Position
As Global Clinical Affairs Manager, you will be working with:
New Product Development and Product Modification Processes (PDP & PMP) - be the Clinical subject matter expert and ensure there is robust plan to generate clinical evidence as part of the development activities and safeguard that all clinical matters are considered in the development process.
Marketing - be the Clinical expert when it comes to communicating the clinical value of our products. You will review and sign-off marketing collateral generated in liaison with the product owners.
Post Market Surveillance (PMS) process - take part in the important work to monitor how our products help customers and patients and compile appropriate data and creating the clinical sections of Post Market Surveillance reports.
Clinical Evaluation Reports (CER) - as the Clinical expert you will have the ownership of product CER's and updating/creation of product family CER's. This work includes tasks such as:
• Analyze and synthesize clinical data, risk management assessments, published literature, clinical investigation results and field performance data in order to evaluate product safety and performance
• Interface with key functional areas (e.g. Product core team, Regulatory, Product Category Marketing and Vigilance Teams) to obtain necessary information and documents required for the development of CERs
• Develop therapeutic and device operation knowledge and apply this knowledge to clinical assessment and development of evaluation reports for corresponding product/s
Support the Quality Assurance Process for existing products - as the Clinical expert you will participate in Health Hazard Evaluations, including attendance at Product Quality Board calls, customer complaint investigations and vigilance reporting activities.
The Ideal Candidate
We believe that the right candidate has BS Degree in clinical field i.e. Nursing, Physical Therapy or relevant life science experience. You have minimum 3 years clinical experience in Medical Device, Pharma or life science industry.
• 2+ years' functional experience in clinical writing, literature reviews, clinical studies or Clinical Affairs function
• Ability to work in a very varied, multi-cultural, international environment across time zones
• Experience in conducting/reviewing product risk assessments
• Experience working with Product Development and Regulatory Teams for a medical device manufacturer
• Ability, talent, commitment and ambition to assume increased scopes of responsibility in organization
• Possess ability to develop excellent working relationships with key personnel, especially with the leadership and Sales & Marketing teams, within Supply Chain and R&D Support functions.
We look forward to your application. Applications will be reviewed and interviews scheduled continuously as applications are received. Please apply no later than 28/9.
Everything we do - we do with people in mind. Our motivation lies in the needs and challenges our customers face, and our driving force is our people, who care about creating the best possible outcomes for our customers.
For those with a passion to improve outcomes for others, a rewarding career at Arjo awaits. We look forward to receiving your application!
Together we can make a difference
Arjo is a globally minded company with a Swedish heritage, where a thriving international environment is driven by Swedish leadership culture. As a company that puts people at the heart of everything we do, Arjo employees are our partners in our mission to improve lives.
The Medical Affairs department is growing and we are looking for Global Clinical Affairs Manager to Arjo's HQ in Malmö.
Publiceringsdatum2018-09-12Så ansöker duSista dag att ansöka är 2018-09-28
Klicka på denna länk för att göra din ansökanFöretagArjo AB Publ
AdressArjo AB Publ
Hans Michelsensgatan 10
21120 Malmö
KontorsadressHans Michelsensgatan 10
Jobbnummer 4342951
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