Pharma Clinical Regulatory Innovation Leader - Michael Page International Netherlands SA
Amsterdam, NH 1066tk
Over de vacature
Work closely with TCS ADD regulatory product, business development, marketing and sales teams as well as multiple pharma leaders at a global level.- Use knowledge and experience within regulatory for business purposes
Client Details
My client is present in 40+ locations and has 450000+ FTEs with a purpose of helping organization in their growth. As a consultancy firm, they operate within healthcare, IT, banking, High tech, manufacturing...
Description
- Responsible for overall advisory of regulatory strategy & solutions and innovative trends in the regulatory domain at global level.
- Co-leads the design, strategic positioning & roadmap of solutions in regulatory submission planning & monitoring, publishing & aggregate reporting, data anonymization, product labelling, intelligence collection & dissemination
- Co-leads regulatory thought leaderships (e.g. publications) and external visibility (e.g. webinars, conferences)
- Co-leads regulatory content authoring for various documents
- Co-leads regulatory strategic external partnerships (e.g. suppliers, other organizations)
- Drives Health Authority engagements for innovative technology solutions.
- Support business development team with industry network connects and go-to-market strategy in the regulatory domain
- Co-leads regulatory customer presentations & workshops
- Participate & provide inputs for regulatory innovation days & cross-pharma meetings
Profile
- Degree in sciences (e.g. e.g. biology, biomedical, pharmacist) or equivalent by expertise. PhD is an advantage
- At least 6 years of global drug development experience in patient & site engagement solutions gained preferably at top-15 pharma companies or clinical research organizations (CROs)
- In-depth hands-on expertise of regulatory processes, needs and challenges (e.g. submission planning & monitoring, publishing & aggregate reporting, data anonymization, product labelling, intelligence collection & dissemination) and innovative trends in the regulatory domain at global level. Hands-on expertise in F2F engagements with various Health Authorities for innovative technology solutions.
- Expertise in other domains (e.g. clinical operations, safety) and stakeholder engagements (e.g. ethics committees, patient advocacy & site advocacy organizations, non-profit organizations) is an advantage.
- Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. Transcelerate, IMI)
- Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language
- Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.
Job Offer
- Strategic role within a fast growing organization
- Possibility to work in Netherlands, Germany, France, Belgium
Salaris
100,000 - 120,000 /jaar
Bonus (based on experience)
Bonus (based on experience)
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