OBS! Ansökningsperioden för denna annonsen har
Are You good at, and enjoy, writing clinical documentation and building clinical strategies?
Then maybe you are ready for a key role at one of the leading global providers of medical devices within bladder and bowel continence care?
You will be a member of the Global Medical Affairs department, we are an agile group of experts waiting for You to join us in the important work of planning, generating, evaluating and documenting scientific evidence to meet commercial needs and regulatory requirements. If this sounds interesting, please keep reading.
As specialist in putting clinical evidence into a business and regulatory context the role requires high scientific knowledge, medical writing capabilities, integrity and a broad understanding of external requirements/internal strategies. You will be one of two colleagues managing clinical evaluations and driving the cross functional evidence planning for Wellspects full range of products.
Management of all deliverables related to Clinical Evaluations
The development of Clinical Evidence Programs i.e. to lead cross functional planning forums to support business objectives
To define, and follow up on, Post Market Clinical Follow-Up initiatives including managing PMCF-surveys
To optimize the use of clinical evidence to support successful registration, positioning and life cycle management
To represent the function in external (e.g. audits, inspections) and internal (e.g. projects and meetings) forums as subject matter expert
To contribute from early product development and throughout the products life cycle
Qualification / Background:
PhD degree, or equivalent
Approximately 5 years of documented relevant experience, preferably in conducting Clinical Evaluations
Documented experience in clinical research planning e.g. study designs/methodologies
Documented experience in scientific writing, literature search strategies and analysis
Thorough understanding of applicable regulations and guidelines such as MDR and MEDDEV 2.7.1.
Understanding of medical device development and product life cycle requirements
Clinical experience, preferably within Urology a/o Enterology, is an advantage
Proficient in English (verbal and writing)
We believe that you are a positive and driven person with the ability to extract, and communicate, relevant information from various sources such as scientific publications, reports and post market surveillance data. You are excellent in writing regulatory documentation. You strive for progress and are comfortable in managing cross functional forums. You are used to work independently digging deep into extensive data sources, yet with an appropriate sense of urgency. Strong stakeholder management is key as your success partly is based on your cross functional interactions. You challenge and explore status quo with a clear ambition of constantly improving our way of working.
We are interviewing candidates continuously, so to enhance your chances, we recommend that you send us your application as soon as possible.
We look forward to hearing from You.