Transforming systematic literature reviews and evidence collection through responsible AI

Consulting and/or freelance manager for projects and roles in Medical Affairs, Clinical Marketing and Clinical Affairs/Research for medical device, cosmetic, diagnostic and pharmaceutical companies.Personal strengths: all round professional and strategic thinker, fast learner and also likes to provide hands-on support. Worked in all aspects of clinical research and medical affairs as well as marketing focused roles, and able to build a bridge between clinical strategy/operations and clinical marketing. Experienced in setting up strategies in Medical Affairs and Clinical Marketing, strategic evidence planning and clinical study development, designing and execution of medical tactical plans (pre-launch and post launch phase), track record in setting up clinical education programs. Experience in market access projects involving value creation, systematic literature reviews and product registrationsAvailable for:- large en small projects, interim or project based- hands on, just advice or a fresh perspective - Medical Affairs/Medical Advisor activities, such as developing scientific marketing materials, competitive and standard of care landscaping, scientific value development, creating KOL strategies, and product launch support- Medical Education projects- Clinical Research projects, such as study development, clinical study plan or study plan strategies- Clinical Affairs projects, such as drafting Clinical Evaluation Reports, PSURS, PMS plans, SSCP.For for more information please go to www.cjb-clinicalmarketing.nl or contact me at cbocker@cjb-clinicalmarketing.nl or + 31 6 54 65 78 06

Medical device, aesthetic care, professional skin care/cosmetics

Oncology

Women’s Health - diagnostic markers

Women’s Health

- Marketing planning and strategy for EMEA- Market development- International product promotion and launches- Development of KOL relationships- Positioning and messaging for core surgical applications in launch countries- Conduct market research and data analyses in support of product strategies - Development and implementation of promotional materials and tradeshow/ congress strategies.- Product portfolio management, including inventory management and forecasting, - Brand management across applications and geographies.

Part of core team introducing LifeCell and Strattice Reconstructive Tissue Matrix in EMEA markets from a medical marketing and clinical operations perspective. Main activities can be summarized as follows:- Clinical Research Study Management for post-marketing study - Study development and preparation of clinical research study and clinical strategy- Responsible for overseeing creation and finalization of Clinical Study Plan and preparation of study related documentation- Identification, review and targeting Investigated Initiated Studies- Developing and introducing Professional Medical Education events in EMEA and managing Events team- Market development - Organisation of scientific symposia- International Key Opinion Leader identification, recruitment, engagement and management- Creation of medical marketing materials and messages

CLINICAL STUDY MANAGEMENT for wound healing and intensive care business unit- Development of clinical research activities in new department- Identification and development of Standard Operation Procedures- Support product launches with post-marketing clinical research projects- Protocol and CRF development- Study initiation - Training and guiding new CRA- Input for clinical study development planMEDICAL AFFAIRS for wound healing business unit- Market development and pre-launch activities- Identification of product evidence gaps and clinical benefits- Setting up strategic road map for clinical studies, including study design and budget- Communication of outcome and results of clinical studies in marketing messages- International Key Opinion Leader identification, recruitment, engagement and management- Creation of scientific marketing material- Creation of value dossiers, clinical guidelines and consensus documents- Generate clinical outcome reports and publications: manuscripts/scientific publications- Presentations at medical education events and scientific symposia- Training of sales force and in country sales and marketing management- Review of investigator initiated study protocolsHEALTH ECONOMIC and reimbursement activities- Support of cost-effectiveness evaluations and creation of scientific/health economic publications- Development and launch of health economic tools for physicians and hospital administrations (Budget Impact Model)- Support reimbursement/health economics department with clinical and economical evidence and input for models and documentation for governmental bodiesPRE-LAUNCH ACTIVITIES- Scientific input and support of new product development process – ideation - Market size estimations and identification of target markets- Input for customer Focus Groups to test new product ideas- International liaison with R&D and Marketing in product development and pre-launch phase

Responsible for Clinical Marketing and Clinical Research activities, such as:- Setting up and management of post marketing study (protocol and CRF development, site selection, EC submissions, etc)- Support for new product launch- Clinical Research Management for Benelux for International post-marketing study- Responsible for creating clinical material for sales force- Updating scientific information and communication to sales force and customers- KOL development and engagement

Experience with phase IIIb and phase IV Good Clinical Practice (GCP) trials in oncology and nephrology.- Communication with Medical Ethics Committees - Selection and interview of participating sites- Preparation of study materials- Training of site staff- Initiation and monitoring sites- Closing and rounding off sites

Territory management for products in gastro-enterology, pain management, and nephrology.