MEDTECH] MANAGER, MEDICAL AFFAIRS, CMO OFFICE

POSITION SUMMARY.
The purpose of the position is to provide medical supervision, support business activities, evidence generation/dissemination, educational activities and engage with internal/external stakeholders.
Leading with an outside-in vision to assimilate opportunities identifying market unmet needs, this role provides medical/scientific insights.
Essential / Principal duties and responsibilities.
1)Medical Governance.
To ensure health care compliance on promotional material and health care professional qualification in accordance with J&J policy, company GOP/SOP and related working procedure.
To ensure the contents and medical claim in following parts, including indication, contraindication, potential complications, clinical trial related contents, caution/precaution and adverse event are accurate, fair and objective.
2)Safety Vigilance.
To work with vigilance safety members as a team to ensure the information regarding adverse events and complaints in the field, facilitate a correct and transparent communication on adverse events and complaints internally and properly review them.
3)MIR.
To provide scientific and medical information to internal stakeholders and external customers, including unsolicited requests from healthcare professionals to ensure clinically appropriate and safe use of company products.
4)To collect the Investigator Initiated Study (IIS) ideas/proposals for research grant, ensuring that specific evidence needs are assessed through medical science liaison and the proposals are discussed within local or global internal committees collaborating with clinical affairs members.
Regarding non-clinical studies, coordinate and track the progress on contract, execution and publication for studies.
5)To plan non-clinical studies internally for local evidence generation.
Coordinate internal committee approval process to execute them collaborating with external investigators.
Coordinate contract, execution and publication for studies.
6)In accordance with the company strategy, to engage with external stakeholders by medical science liaison.
Build and maintain professional relationships with external experts to gain understanding, insights, and opinions on treatment patterns, including scientific activities and healthcare professionals needs within disease areas.
7)To work with cross-functional partners, providing medical/scientific support for evidence activities.
Maintain medical/scientific contacts with local investigators.
Provide medical strategic plans and solutions to support business team on product and/or procedure management for related therapeutic area, in terms of evidence generation/dissemination and other related activities.
8)To support educational activities for internal or external stakeholders, 9)To input into risk management processes for hazard/harm identification & risk mitigation in cross functional team.
10)To develop an understanding SOPs and proper working instructions to ensure the internal process following company policy and related regulation if applicable.
11)Initiative/support for publication of developed evidence.
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
Qualifications 必須 1.
Business level of English communication skills 2.
Clinical/Technological knowledge in the field of cardiology, especially catheter ablation for arrhythmias 3.
Ability to communicate effectively with external and internal stakeholders across the world 4.
尚可 0..
xperience/expertise in scientific/clinical research (preferable) 1.
Ph.
.
degree (preferable)