- Lead and implement regional MI globalization in Asia region.
- Manage MI callcenter/MI vendors.
- Manage regional MI. Respond to escalations.
- Oversee the development and approval of SRLs/ FAQs and required global assets.
- Develop and implement prelaunch plans.
- Serve as reviewer and approver on MeRL committee/PRC.
- Be aware of the global industry standards and compliance for MI and help to support and reinforce those with all internal and external stakeholders in daily work.
- Liaise as needed with crossfunctional groups to deliver on countrys MI needs.
- Provide crossfunctional groups training on MI processes MI compliance best practices and minimum standards to vendors and internal Santen as needed. Provide product training to vendors and internal santen as needed. Support sales and medical affairs training vendor training and other training as required by various functions.
- Oversee document management and CRM systems (example Veeva IRMS).
- Develop and manage SOPs/templates/WPs/trainings on MI
- Provide periodic metrics and analytics for products with global insights.
- Lead congress booth process and planning in alignment with TA leads and other MA as relevant. Staff congress booth.
Qualifications :
- Advanced Degree in Scientific discipline or applicable Health Sciences field (PhD/PharmD/MD). Comfortable with scientific/medical data analysis and interpretation.
- Understanding of product development process. Familiarity with product labeling and packaging material.
- PMP or project management certification preferred.
- Minimum of 7 years previous Global Medical Information experience. Familiar with global Industry standards and best practice in MI. Strong understanding of global MI compliance commercialmedical separation. (Experience in South Korea Vietnam or Thailand MI would be a bonus).
- Strong medical writing review/editing experiencedeveloping and authoring SRLs and FAQs.
- Experience with literature searches.
- Experience with congress booth staffing.
- Experience training crossfunctional teams on MI.
- Experience with process development (SOPs/templates/WPs)
- Experience with audits
- Experience with Veeva IRMS and Tableau preferred.
- Strong on project planning organization and time management. Ability to adapt and prioritize to manage multiple project and timelines
- Travel approximately 1015% annually.
Additional Information :
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our longterm vision outlined in Santen 2030 we are committed to be a Social Innovator addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.
If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.
Remote Work :
No
Employment Type :
Fulltime