2. Oversees Doctors’ Accreditation and Credentialing, and Re-accreditation matters and to ensure that all doctors’ accreditation status is updated timely.
3. Manages medico-legal matters and Serious Reportable Events promptly and according to timeline.
1. Providing support to the Medical Advisory Board and Continuing Medical Education Committee.
2. Oversees Doctors’ Accreditation and Credentialing, and Re-accreditation matters and to ensure that all doctors’ accreditation status is updated timely.
3. Manages medico-legal matters and Serious Reportable Events promptly and according to timeline.
...
As the Medical Affairs Director, you will be responsible for providing strategic leadership and direction to the Medical Affairs department. You will play a pivotal role in shaping the medical strategy, fostering relationships with key opinion leaders (KOLs), and ensuring the scientific integrity of our products. The ideal candidate will possess a strong background in medical affairs, exceptional leadership skills, and a passion for driving innovation in healthcare.
We are looking for a highly motivated Medical Affairs Director who is passionate about patient-centric HIV care, treatment, prevention, and Pre-exposure Prophylaxis (PrEP).
Candidate must be a self-starter with a proven track record of success in prior roles.
...
The incumbent will be accountable for the development, execution, and oversight of medical and scientific strategies for one or more products within the Therapeutic Area (TA). You will be responsible for:
Proactive assessment of external medical environment perspectives that shape global medical strategies.
...
Perform literature reviews and research drug pipeline and portfolio to provide actionable insights for business development.
Manage research project documentation and prepare grant proposal.
Develop strategies to engage with regulatory authorities and industry/academic partners to establish new standards for the adoption of Vysioneer’s novel technology in drug development.
...
Everything we do is led by our company values of integrity, being patient centric, taking ownership, delivering results, and communicating openly. These values are essential to Astellas’ relationship with its employees and now is an exciting time to join us as we continue to evolve as a cutting-edge, value driven life sciences innovator.
Purpose of the Position:
The incumbent will be accountable for the development, execution, and oversight of medical and scientific strategies for one or more products within the Therapeutic Area (TA). You will be responsible for:
...
You will be responsible for managing and coordinating all medico-legal issues and providing support to clinical and non-clinical departments on other general legal matters for timely reporting of events.
You will also oversee the clinical administration team that supports the development of the clinical research, innovation, education and informatics as we develop the new Eastern General Hospital.
You will supervise the Clinical Services and Medical Affairs staff in developing clinical governance frameworks and policies, improving professional and clinical quality and practice as well as overseeing the Clinical Notes Review Programme to meet regulatory requirements at different project phases of the Hospital building.
You will be responsible for managing and coordinating all medico-legal issues and providing support to clinical and non-clinical departments on other general legal matters for timely reporting of events.
You will also oversee the clinical administration team that supports the development of the clinical research, innovation, education and informatics as we develop the new Eastern General Hospital.
...
1. Support HR Personnel System (HRPS) transitional issues, which include logging, troubleshooting of errors, resolve Service Requests (SR)/ Change Requests (CR), manual updating and exception handling of Home Team Medical Board (HTMB) cases and results.
2. Follow through with the changes in HRPS and its integration with Home Team Medical Information System (HTMIS) i.e. NGEMR EPIC
3. Manage any surge in pre-HTMB cases referred from pre-IPPT medical screening as HRD transits from Financial Year (FY) to Calendar Year (FY) for the annual IPPT cycle
...
Work closely with the other functions in the CRM TA Franchise team (e.g., marketing, MAHA and GTM).
Develop, implement, and execute strategies & activities to bring the benefit of BI medications to patients across the product lifecycle while collaborating and providing guidance to the OPUs.
...
Coordinate the clinical governance meetings (ie MDAC, Division Meeting, Sub-Division Meeting, etc) setup by ensuring the necessary logistic arrangements are made prior to the meeting, memos/reminders are send out to Doctors and relevant meeting documents are well prepared before the meeting.
Follow-up and compile meeting agenda prior to the meeting.
...
Provides technical guidance and regulatory training.
Acts as company representative, developing and maintaining positive relationships with External Audit through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
...
Support development of agenda, scientific content and advice on selection of speakers including speaker briefs to enable high quality scientific education programs for the brand
Advise, coordinate and monitor scientific evaluations and field studies
Identify, support and facilitate potential sites and investigators for studies/trials working closing with global Medical Affairs team
...
4. Typing up legal documents such as an agreement or contract when needed
5. Performing legal research, such as product research, for registration
6. Coordinate with manufacturers and other firms to obtain and exchange information and documentation related to legal matters, such as completing the form for Medical Product Registration (MDA).
...
Support development of agenda, scientific content and advice on selection of speakers including speaker briefs to enable high quality scientific education programs for the brand
Advise, coordinate and monitor scientific evaluations and field studies
Identify, support and facilitate potential sites and investigators for studies/trials working closing with global Medical Affairs team
...
- Maintain strong knowledge in areas supporting the portfolio and effectively communicating medical knowledge to all stakeholders across the region
- Support development of agenda, scientific content and advice on selection of speakers including speaker briefs to enable high quality scientific education programs for the brand
- Advise, coordinate and monitor scientific evaluations and field studies
...
· Manages devices products related lifecycle activities for the assigned projects to ensure regulatory requirements are met
· Supports JAPAC Area RA Lead, affiliates and Global Regulatory Affairs in variation related activities (i.e. regulatory assessment, etc.) for the assigned projects
· Implements regulatory strategies for the assigned projects for countries in JAPAC under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.
...