Title:  Clinical Trials Specialist

About us

We are an international dermocosmetic company with a clear purpose: Inspire everyone we touch to enjoy healthy, happy, beautiful lives.

We are a purpose-driven company, and we want your day to day to have a positive impact on our communities and planet. We are proud to be B Corp certified. However, forming part of the solution also comes with great responsibility: to be a force for change towards a more sustainable world.

Do you want to join the Challenge?

What are we looking for?

What are we offering?

By joining Isdin, you can change the life of a lot of people worldwide. 

In addition, we offer some interesting benefits, what makes us a top employer company:

• Flexible entry hours and home office policy. 
• Private medical insurance.
• Discount in our employee store. 
• Wellness benefits.
• Christmas lot with several products.

What will your challenges be?

Project related: 
Active participation in project kick off and preparation of Clinical Development plans
Collaboration in review of clinical trials (CT), studies and clinical tests outlines, along with any stakeholder involved.
Preparation and review of documentation for studies execution, along with advisors / investigators.
Review and approval of text/claims for cosmetics products (and any other applicable Regulatory product category).
Participation in the Risk Assessment as well as the related documentation for Medical Devices (Clinical Evaluation Report, PMCF, etc…)
Elaboration of documentation supporting product´s efficacy based on clinical trials/studies and results as required for product regulatory dossier, including presentations for sharing with other areas.
Collaboration in the creation of papers for medical journals and congress communication based on CT results.

Study related: 
Planning and conduct of CT/studies and tests, including any products of any ISDIN Regulatory categories; preparation, review and/or approval of all associated documentation: synopsis, protocol, report, timelines, study plans (when applicable –i. e statistical analysis, monitoring,- IP related documents, and any other study-related documentation.
Photobiological studies (in vitro and in vivo) management including planning, follow up, documentation review and approval as required for every product and region.
Management of study budget, including approval of invoices payment and updating on regular basis.
CRO and other vendors selection according to Project needs and follow-up ensuring timings and test execution.
Tracking of all studies managed by Clinical Affairs Area ensuring all of them are registered and documented following ISDINs procedures, also ensuring eTrial Master File key documents related to Clinical activities are properly filled in.
Cooperation with other Areas: PreClinical, Regulatory, Corp. Med. MKT, Corp. Product Safety, Affiliates, Corp. Legal, Corp. QA, etc…
Collaboration in the preparation of any documentation related to the relevant ethics committees, when applicable.
Management of clinical trials/studies registration in relevant databases, when required.
Collaboration in audits/inspections and CAPA implementation.
Ongoing review of CT data when applicable.
Ensuring the CTs follow GCPs, with applicable international quality standards, with the agreed (CRO) SOPs, policies and standards amongst others.

Non-project related: 
Continuing education and training on clinical research topics and relevant state of the art. 
Collaboration in SOPs update/creation/training.
 

Are you the one we are waiting for?

• Education: Degree in Health Science such as Medicine, Pharmacy, Biology, Biochemistry, Chemistry or similar.
• Experience: Experience of 3 years in similar position, either in Corporate Company or CRO.
• Language: English - High Level.

Equal Employment Opportunities Employer

At ISDIN, we care above all about the talent you bring. That is why, throughout the recruitment process, we will respect the principle of equal opportunities, refrain from any kind of discriminatory attitude while always fostering our respect for people.