묘사
Key Responsibilities Include:
- Responsible and accountable for Medical Affairs strategy of therapeutic/disease area (TA/DA) including compounds/product development/business plan.
- Collaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall Medical Affairs strategy for product lifecycle aligned with company brand strategy.
- Responsible for people development and operational budget management of TA/DA group.
- Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC rules.
- Manage the high-performing organization and to provide the healthier working environment.
- Evaluating, developing and implementing training programs designed for further improvement of strategic capability by assessing needs, skills and scientific knowledge
- Providing advanced scientific information on Janssen products (incl. reactive off-label information) to HCPs in compliance with internal and external regulations
- Supervise all activities of each member in the group; Supervise to manage and utilize medical information for business; Supervise to handle inquiries from internal as well as external customers; Oversee the maintenance of product FAQ portfolio on Janssen products; Supervise providing appropriate information to relevant dept; Overseeing of Handling call center operation; Supervise reviewing materials to be distributed to external customers
- Driving functional excellence and alignment
- Managing operational TA budget and allocating human resources based on brand strategy and product life cycle
- Developing & managing TA strategy aligned with other critical functions/regions (R&D/BU/AP/GL); Supervision of Medical Affairs Plan (MAP)
Provides input into early development through core membership of TASTe; Assigning members for TA activities & product teams (JCoT, CVWG, IEGP etc ); Provides input into brand strategy
- Leading entire TA activities by providing clinical direction and strong leadership
- Accountability and supervision of MAP and monthly report by products
- Accountable for execution of all TA activities
- Collaborates with functional directors to improve the functional excellence and alignment
- Leading members in TA/DA departments
- Accomplishing TA objectives by establishing plans and KPI measurements with functional directors.
- Establishing good relationship with internal stakeholders (BU/R&D/AP; group level, individual issue or task oriented)
- Developing professional capabilities for TA departments including TA knowledge, data generation capability, and leadership.
- Managing TA/DA budget and human resources
- Managing operational budget and allocating human resources upon Medical Affairs plan
- In collaboration with finance controller and alignment with AP/GL MAF
- Managing MAF initiated clinical/non-clinical study
- Evaluating new IIS proposals
- Develop close relationship with Thought Leaders in the TA (TOP KOL Management)
- Developing KOL management plan with MSL team in collaboration with R&D/BU
- Maintains strong scientific collaborations with thought leaders within TAs to efficiently collect medical needs.
- Driving customer focus
- Accomplishing functional objectives by developing MAF plans
- Setting appropriate benchmarks and develop KPIs
- Tracking and evaluating functional activities with KPIs
- Developing the DA strategy aligned with the brand strategy under supervision of TA Director
- Creating Medical Affairs Plan in disease areas based on brand strategy under supervision of TA leader
- Gathering and analyzing the unmet medical needs from internal & external stakeholders
- Managing evidence generation / publication in align with brand strategy in a compliant manner of internal and external regulations
- Developing MAF study and publication plan aligned with brand strategy/IEGP
- Driving and executing MAF study in collaboration with KOLs and MAO
- Generating publications of MAF study collaborating with KOLs and MAO
- Day to day project management (lead) for MAF activities, report the progress to internal stakeholders
- Create a detailed work plan and determine the resources (time, budget, FTE etc) required.
- Develop a schedule for project completion that effectively allocates the resources to the activities
- Review the project schedule with the team affected by the project activities, revise the schedule as required.
- Monitor the progress of the project including budget management and make adjustments as necessary to ensure the successful completion of the project.
- Update to internal stakeholders in the company on the progress of the project.
- Review the quality of the project completed on a regular basis to ensure that it meets the project standard.
- Gathering and analyzing medical needs through communication with HCPs
- Gathering insights from HCPs and identifying new unmet medical needs
- Assessing medical needs/gaps in collaboration with TA department
- Analyzing medical needs and gaps based on inquiries and providing appropriate information to product strategy
- Support MR medical knowledge trainings in collaboration with SL&T
- MSL activities
- Leading MSL group members
- Accomplishing group objectives by establishing plans (MSL activity and KOL engagement) and KPI measurements with functional directors
- Managing operational budget and allocating human resources upon Medical Affairs plan
- Establishing good relationship with internal stakeholders (BU/R&D; group level, individual issue or task oriented)
- Developing professional capability for MSL (including TA knowledge, leadership and people management skills)
- E2E execute MAF studies in collaboration with TA and MAO
- Developing strong relationship with KOLs in collaboration with TA (lead) and internal stakeholders (KOL Engagement)
- Developing the KOL engagement plan aligned with Medical Affairs strategy
- Executing scientific communications effectively with KOLs based on KOL engagement plans
- Managing scientific knowledge and medical information
- Collecting and analyzing scientific knowledge and medical information (incl. scientific competitive intelligence)
- Disseminating the analyzed scientific knowledge and medical information to internal stakeholders (scientific slide set, congress analytical report, evidence book, product FAQs, and reply to inquiries)
- Secure scientific quality of medical and promotional materials the company issues through review processes from scientific/medical points of view
- providing the analyzed scientific knowledge and medical information to internal stakeholders (scientific slide set, congress analytical report, evidence book, product FAQs, and reply to inquiries)
- Responding to customer inquiries escalated by internal stakeholders.
- Conduct training sessions for staffs so that they can gain optimal use from the Information Services. These sessions should focus on accessing the information, feeding back local information into a central database, and the importance of timely and accurate delivery of information as a competitive advantage.
- Supervise handling inquiries from external customers
- Handling medical information center operation under supervision of MIC Group Manager
- Creating and maintaining of product QA section on Janssen website
- Planning MAF organizational strategy and support functional excellence and alignment with tracking KPIs
- Support MAF head for planning MAF strategy
- Implementing and analyzing the KPIs with functional directors
- Conduct internal Medical Affairs Event (e.g. Town hall meeting)
- Support managing operational division budget and allocating human resources based on TA strategy and product life cycle
- Assigning member for record coordinator of Medical Affairs
- Oversee managing and filing the all contracts in Medical Affairs
- Supervise managing the databases (CTMS/TMS) and support management of trial master files
- Supervise a role of secretariat
- Supervise monitoring changes in local regulations related Medical Affairs activities
- Ensure Medical Affairs SOP in place and updated to reflect any changes in local regulations as well as any changes in regional / global policies
- Managing MAF initiated clinical/non-clinical study operation
- Providing advanced scientific information on Janssen products (incl. reactive off-label information) to HCPs in compliance with internal and external regulations
EXTERNAL AND INTERNAL INTERACTIONS
The role involves extensive interactions with :
- Domestic and international KOLs in responsible therapeutic area.
- Regional leadership team
- Other local management board members
- Sales and Marketing leaders in JPKK
- R&D, PV, PMS and Regulatory Affairs leaders in JPKK
- All Medical Affairs leaders and members
The additional job scope at Director level:
- Responsible and accountable for Medical Affairs strategy of therapeutic area (TA) including
compounds/product development/business plan.
- Collaborates with internal and external stakeholders including key opinion leaders to develop and
implement the overall Medical Affairs strategy for product lifecycle aligned with company brand
strategy.
- Responsible for people and operational budget management of TA departments.
- Responsible for ensuring that all Medical Affairs activities are compliant with Japan Legislation and HCC rules
자격
Qualification:
- MD, PhD, MBA is desirable
- Work experience of 2-3 years as a people manager in MA, R&D, and MKT of pharmaceutical industry.
- Work experience of 3-5 years in specific TA is preferred.
- Deep understanding of local regulatory policy and industry’s code of practice related to drug registration, pharmaceutical promotion and clinical study is preferred
- Understanding on operations and execution of clinical studies is preferred.
Competency Requirements:
- Integrity and adherence to Johnson & Johnson Credo values.
- Collaboration, strategic thinking, and attention to detail.
- Strong communication skills in Japanese and English, with the ability to interact across functions.
- Advanced analysis of complex business situations and trends.
LIST JOB SPECIFIC COMPETENCIES/SKILLS REQUIRED:
1. Business level of Japanese and English communication
2. Interpersonal flexibility to effectively interact with a broad range of personnel in a cross-functional team environment.
3. Presentation skills and business acumen as a necessity
4. Demonstrated ability to analyze complex business situations and identify trends and creative business solutions.
5. Awareness of, and adherence to, Johnson & Johnson Credo values and International Health Care Business Integrity Guide
6. Possess GLP competencies as Senior Leaders