Clinical Regulatory Innovation Leader (d/m/w)
Startdatum: ab sofort
Gestalten Sie Ihre IT-Karriere bei einem außergewöhnlichen Technologieunternehmen: Tata Consultancy Services (TCS) führt internationale Top-Kunden mit mehr als 450.000 Expertinnen und Experten in die digitale Zukunft.
This position is part of the strategic group of TCS Life Sciences and will work closely with TCS ADD platform development leaders, marketing, sales and top leaders in life sciences industry.
You will drive the shaping and designing of TCS ADD platform offerings, with primary focus on regulatory domain, and translate into easy-to-understand, tangible business & operational language. You will engage and understand life science needs, communicate the needs to platform development leaders and introduce the entire TCS ADD platform offerings to the life science industry. You will not only support novel partnerships with life science companies but also explore engagements with patient or site advocacy groups, ethics committees/health authorities, suppliers and non-profit organizations. You will provide strategic input for further development of TCS ADD offerings
Main responsibilities and duties
- Drive and co-lead the strategic development of TCS ADD offering for regulatory domain
- Facilitate further embedding & shaping of all TCS ADD offerings in pharma industry in close collaboration with TCS ADD platform development leads, marketing and sales team.
- Provide leadership support to pharma leaders and teams to design and shape innovative programs in-line with their needs, using TCS ADD offerings in a flexible way.
- Provide strategic input on innovations and emerging solutions in the TCS ADD portfolio
- Support with identifying new leads for strategic partnerships for TCS ADD offerings.
- Collaborate with sales and marketing teams to design external communications strategies (e.g. translate in easy to understand business language) and drive TCS ADD platform awareness.
- Provide support to cross-industry initiatives for setting up next generation of clinical trials
- Attend/represent TCS ADD offerings at various industry conferences, meetings and events.
- Be aware of relevant developments & innovative trends in pharma industry
Qualifications and education
- Master’s degree in sciences (e.g. e.g. biology, biomedical, pharmacist) or equivalent by expertise. PhD is an advantage
- At least 8 years of global drug development experience gained at Pharma Companies or Clinical Research Organizations (CROs), as well as good insights of innovative trends ongoing in Regulatory domain, is required.
- In-depth hands-on expertise in regulatory submissions, publishing, redacting of diverse regulatory documents (e.g. product label, safety reports, CCP) is essential. Profound expertise with Health Authority engagements and challenges at a global level is required.
- Expertise in other clinical research domains like e.g. clinical operations or safety is an advantage.
- Expertise with patient advocacy & site advocacy organizations, non-profit organizations, innovative vendors is an advantage.
- Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Strong senior management connections and cross-pharma connections (e.g. leadership role in cross-industry forums like Transcelerate) is an advantage.
- Outstanding presentation skills with ability to concisely present information in clear and understandable format and translate state-of-art technology concepts into easy-to-understand operational language.
- Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity.
- Fluent in English and German
Flexible Arbeitszeiten • Betriebliche Altersvorsorge • Barrierefreiheit • Gesundheitsmaßnahmen • Betriebsarzt • Coaching • Parkplatz • Gute Anbindung • Mitarbeiterrabatte • Mitarbeiterhandys • Mitarbeiterevents • Internetnutzung
Weitere Informationen finden Sie hier.