Head of Medical Affairs - Mölndal, Sweden
Dentsply Sirona
- Mölndal, Västra Götaland
- Permanent
- Heltid
- Carrie out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work.
- Responsible for clinical and Health Economic Evidence to contribute to registrations in different geographies and countries.
- Establishes and maintains successful collaboration and partnerships with third party vendors (e.g. CROs), study investigators and site research personnel to facilitate successful execution of clinical studies.
- Support development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
- Ensure that our Medical Affairs team maintains a continuous state of audit readiness.
- Implement legal requirements of contracts, non-disclosure agreements, and financial agreements in clinical programs.
- Clinical Technical documentation such as Clinical Evaluation Plan/Report, Post-Market Clinical Follow up Plan/Evaluation report, State Of The Art and Literature Searches.
- Health economy support to Marketing and Sales as well as to new product development projects.
- At least Master´s Degree in the Sciences or Medical discipline, PhD preferred.
- Demonstrated ability to understanding and interpret clinical data and literature.
- 4 - 6 years of industry experience in managing medical device clinical studies and clinical evaluations.
- Previous experience managing teams.
- Strong leadership skills; self-starter, good listening skills.
- Knowledge of ISO-14155, FDA and MDR requirements.
- Excellent communication, organizational and people management skills.
- Independent, proactive, confident and self-directed individual.