Lediga jobb Life Technologies Europe B.V. Nederlaenderna Fil i Uppsala

Se alla lediga jobb från Life Technologies Europe B.V. Nederlaenderna Fil i Uppsala. Genom att välja ett specifikt yrke kan du även välja att se alla lediga jobb i Uppsala som finns inom det yrket.

Clinical Study Manager

CLINICAL STUDY MANAGER LOCATION: Uppsala, Sweden IMMUNODIAGNOSTICS DIVISION Thermo Fisher Scientific’s ImmunoDiagnostics Division (IDD) develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and follow-up of allergy and autoimmune diseases. With 1,900 employees worldwide, IDD is the global leader in in vitro IgE testing for allergy and the European leader in autoimmunity diagnostics. HOW WILL I MAKE A DIFFERENCE? ... Visa mer
CLINICAL STUDY MANAGER
LOCATION: Uppsala, Sweden
IMMUNODIAGNOSTICS DIVISION
Thermo Fisher Scientific’s ImmunoDiagnostics Division (IDD) develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and follow-up of allergy and autoimmune diseases. With 1,900 employees worldwide, IDD is the global leader in in vitro IgE testing for allergy and the European leader in autoimmunity diagnostics.
HOW WILL I MAKE A DIFFERENCE?
You will be joining the Scientific and Medical Affairs team, who is responsible for developing scientific and clinical evidence for both existing and new in-vitro diagnostic products. We manage and govern pre-and post-marketing research and we provide a synthesis of available knowledge and disseminate this knowledge through publications, education and scientific meetings. Our goal is that the scientific quality of our evidence generation activities will impact clinical and health care providers guidelines and therefore have a positive impact on both healthcare and how patients are managed with the ultimate objective of improving patient outcomes and public health.




WHAT WILL I DO?
Generate and communicate evidence with the aim of improving patient access to IDD’s innovative diagnostics, whilst ensuring compliance to all internal and external regulations and guidelines. The CSM will prepare and conduct approval board meetings, oversee contract negotiations, implementation of the study and follow-up on study progress at regular intervals, under the supervision of the Senior Director Scientific and Medical Affairs.
You will interact closely with the medical directors, submitters of applications, product planning and logistics, legal and compliance, with the main responsibilities being to:


• Act as the main point of contact for any incoming applications and communications
• Initiate and managed the approval process
• Prepare, lead and document all approval board meetings
• Initiate contracts and agreements
• Maintain follow-up communication with relevant stakeholders
• Keep metrics on submitted applications
• Educate and train (new) stakeholders on the processes involved


You will also support any audit activities related to clinical validation data submissions and the respective processes involved. In collaboration with Scientific Affairs, you will ensure all generated data can be used for scientific and marketing purposes. You will also have the possibility to participate in the process improvement activities in relation to the areas of responsibilities, and work strategically to help integrate clinical validation activities into the product development process.


HOW WILL I GET THERE?
We are looking for a motivated and proactive individual, who is used to working internationally and has several years of experience from the pharmaceutical, medical device, or diagnostics industry.
The successful candidate should have the following skills and experience:


• Undergraduate degree in a clinical, scientific or related field.
• Documented experience in the IVD industry. Knowledge and experience with applicable regulations and guidelines (e.g. GCP, Sunshine Acts).
• Scientific knowledge in clinical research methods and IDD products is of advantage.
• Demonstrated ability to operate independently, to take initiative, be resourceful, and exercise astute business judgment to drive performance.
• Strong written and verbal communication skills including fluency in English (written and spoken).
• Must have excellent interpersonal, verbal, and written presentation skills.
• Experience in usual software (Word, Excel, Power Point)
• Demonstrates the Thermo Fisher values – Integrity, Intensity, Involvement and Innovation (The Four I’s)




WHAT WE CAN OFFER:
• A career in an international company with a global impact
• Development through continuous learning and developing skills and abilities
• Cooperation with colleagues and teams across business functions, divisions and countries
APPLY NOW on our career site: http://jobs.thermofisher.com


If you have questions about Thermo Fisher Scientific and/or the position - please contact Victoria Johansson (Senior Recruiter Nordics) – [email protected] Visa mindre

Global Scientific Project Manager

Global Scientific Project Manager Introduction The Scientific and Medical Affairs (SMA) team is the voice of the patients and our HCP stakeholders. We apply evidence-based medicine principles to generate clinical evidence for our diagnostic products to meet the unmet clinical needs. The team’s vision is to be the scientific leaders in IDD for demonstrating, communicating and disseminating scientific, clinical and health economic value of our products. SM... Visa mer
Global Scientific Project Manager
Introduction


The Scientific and Medical Affairs (SMA) team is the voice of the patients and our HCP stakeholders. We apply evidence-based medicine principles to generate clinical evidence for our diagnostic products to meet the unmet clinical needs. The team’s vision is to be the scientific leaders in IDD for demonstrating, communicating and disseminating scientific, clinical and health economic value of our products. SMA is responsible for being the voice of the patients and our HCP stakeholders and applying evidence-based medicine principles to generate clinical evidence for our diagnostic products to meet the unmet clinical needs.


How will you make a difference?
SMA leads internal and external activities to reinforce scientific leadership in Allergy and Autoimmunity and develops clinical and scientific evidence to support IDD’s business objectives, and ensures patient safety through effective Medical Risk Management. The team manages and governs pre- and post-market research and provides synthesis of available knowledge and disseminates this knowledge through publications, education and scientific meetings.


What will you do?
The Global Scientific Project Manager is part of the Scientific & Medical Affairs team. The Global Scientific Project Manager reports to Senior Director, Scientific & Medical Affairs.
Your responsibilities:
Manage group’s activities by determining and defining project scope and objectives
Effectively plan and manage resources to ensure successful project completion
Track project progress and costs to meet timelines and budget
Manage contracts with external collaborators and ensure delivery of services
Ensure the group’s finances are updated on a regular basis and adjusted as required
Act as global Clinical Approval Board (CAB) manager
Editor of the Scientific & Medical Affairs website on intranet
Cost effective management of the IDD Infocenter Allergy and Autoimmunity
Drive training initiatives for the effective use of the IDD Infocenter
Disseminate relevant scientific/clinical evidence internally and externally
Influence across the enterprise creating effective and sustainable global relationships
Execute project managemebt by utilization industry best practices



Who are we looking for?
The ideal candidate will have:
An administrative Business Education
A minimum of 3 years’ experience in the pharmaceutical, medical device or diagnostics industry
Past experience in collaborating with clinical, medical and commercial stakeholders in a matrix organization
Ability to operate independently, to take initiative, be resourceful and exercise astute business judgment to drive performance
Fluent in spoken and written English, other languages (preferably Swedish, German) are an advantage
Extensive knowledge of MS Office applications
Excellent interpersonal, verbal and written presentation skills



Appy directly via the Thermo Fisher careers site: job ID 166877BR
Contact Sr Recruiter [email protected] if you have any questions
Application deadline: 22nd September 2021 Visa mindre