Consultancy assignments
Update of training manual on therapeutic area, review and update of internal clinical training slides on product and disease areas, review of speakers slides for international conferences. Sharing experience and knowledge of the device end-user’s needs, limitations and challenges as well as training strategies and needs relevant for the end-user. Compilation of Human factor study report for FDA submission.
Device development
Member of device development teams contributing to the target product profiles and design input requirements as well as to all other aspects of the device design, including user and technical failure mode and effect analysis (FMEA’s) and collaboration with pen developers and manufactures. Engaged in the design, planning, execution, reporting and publicing of user studies and publication of the results.
One of the device development team received the Red dot design award 2012 and the German Design Award Special Mention 2014 for a prefilled pen design and usability. More details
Communication
In charge of development of communication plans, Responsible for presentation of clinical trial design and results internally as well as externally. Participating in the design and creation of intranet pages. Evaluating and reviewing local trial protocols and investigator initiated trial proposals as well as contributing to publications and review of publication drafts. Speaker at international meetings and press conferences.
Developing training manuals and material (IFU, PIL, brochures and videos) as well as product- , hotline – and device training materials. More details
Training experience
Responsible for the training of trial teams, affiliates, vendors and investigators on therapeutic areas, products, injection devices and technique, as well as post market surveillance and vigilance, protocols and CRF completion. Performing annual therapeutic area training for non-medical global staff. More details
Clinical Trials
Leading clinical trial teams and clinical sub teams within the therapeutic areas osteoporosis, post stroke cognitive impairment and tissue sealing. Designing, overseeing and reporting clinical trials from phase II to phase IV and coordinating up to 10 different clinical trials at a time within osteoporosis and rheumatoid arthritis.
Responsible for Clinical Development Plans, evaluation of new indications and in-licensing opportunities, planning and execution of investigator meetings, protocol and scientific advisory board meetings. More details
