Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA. At Flen Health, we are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.
We expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the results of your work, whether individually, as a team or company wide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working eco-system, enthusiastic colleagues, and an attractive remuneration package.
We have an exciting opportunity for Clinical Affairs Specialist reporting to the Clinical Affairs Manager. As a Clinical Affairs Specialist, you will be responsible for providing technical support across the Flen Health product portfolio. You are expected to travel domestically and internationally to attend internal and external meetings. You will also work in a cross-functional team.
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospects
- Learning and development opportunities
- Competitive remuneration according to experience
- Support the preparation of the technical clinical documentation in accordance with the new MDR Guidelines (e.g., CER, CEP.…)
- Support Clinical trial protocols development and management of PMCF/clinical studies (Topical Medical devices as well as well as biological Pharmaceutical products and combination devices)
- Maintain quality and integrity of study data in accordance with company SOPs, applicable laws (MDR) and standard guidelines (ICH-GCP; ISO14155)
- Support review, preparation, coordination and follow-up of CT submissions to ethics committees and competent authorities
- Support the day-to-day clinical operations, including management of vendors (e.g. CRO) and coordination of clinical technical documentation activities
- Support/lead feasibility assessments and selection of countries and sites for clinical studies
- Proactive collaboration with investigators/study team
- Provision of feedback to the clinical line manager regarding study progress
Your profile and qualifications:
- You will hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degree
- Knowledge of the European Union MDR Guidelines
- Knowledge of ISO 14155 Clinical investigation of medical devices for human subjects
- Experience with summary and analysis of clinical scientific literature
- Experience in clinical documentation in wound care or/and dermatology are an asset
- Knowledge of FDA Statutory provisions on Combinational and biological Products is an asset
- Experience with clinical statistical analysis is an asset
- Excellent planning, organisational and interpersonal skills
- Demonstrated collaborative skills and ability
- High energy and self-directed with the ability to rapidly integrate into Flen Health’s culture
- English: fluent; Other languages such as e.g. German or Dutch would be an asset
Are you interested in working with an ambitious and highly dedicated team?
Please send your CV and covering letter by using the form below: