Associate Director Medical and Clinical Affairs
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Directs the operational function of medical and clinical affairs in China to achieve organizational objectives. Provides medical/clinical voice for China market via KOL engagement and data dissemination strategies including publications, independent educational events, and post-market studies. Supports in-country product launches and training, and partners with Medical Safety to support safe product use. Participates as a reviewer in the copy review process within Asia Pacific, and specifically China.
Manages the strategic elements of JJSV study conduct for both pre-approval and post-approval studies, ensuring that operating procedures and
company policies are followed. Develops and manages timelines, resourcing and budget for all China JJSV clinical studies and leads the study execution teams and activities.
Manages relationships externally with Strategic Partners, including universities, research
institutions, and CROs.
Adheres to environmental policy, procedures, and supports department environmental objectives.
ESSENTIAL FUNCTIONS / RESPONSIBILITIES
• Directs the in-country operational function of medical affairs in collaboration with regional/global medical affairs and aligned to regional/global post-market studies/IME strategies
• Oversees the design and implementation plans of medical affairs programs in-country
• Ensures medical affair's objectives are aligned with the goals and mission of the company
• Reviews and approves educational, promotional and reporting materials for use by internal stakeholders via copy approval process for China and APJ
• Strategizes and prioritizes publication proposals for country/region and in alignment with global organization
• Drives data dissemination strategies in collaboration with Professional Education
• Provides strategic input into post-market research study protocols for specific projects promoting company message and value
• Engages KOLs in-country through Ad Boards, conferences, other venues aligned with regional/global KOL management and development strategies
• Directs and implements plans in conjunction with regional medical affairs/clinical operations and in alignment with Regulatory Affairs for both pre-approval and post-market clinical trials as it relates to strategic initiatives
• Provides SME and regional support for implementation of the Post-Market Safety Surveillance Program in collaboration with Medical Safety organization
• Ensures collaborative working relationship between Medical Affairs and internal stakeholders to deliver timely and expert support for product launches and in-market products
• Own processes and information required to execute and support clinical trials including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
• Accountable for the preparation and finalization of key clinical documents which include the clinical protocol, informed consent, case report form, and other essential study documents
• Leads the team and manages study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required to gain approval for testing investigational surgical devices
• Responsible for the selection of investigative sites and Contract Resource Organizations (CRO), and oversight of contracts, timelines, budgets, and contractors, when applicable
Main areas of responsibility in addition to items listed above
Functional and Technical Competencies:
• Demonstrated ability to build collaborative relationships cross-functionally with key internal and external partners and stakeholders
• Ability to influence, shape and lead without direct reporting authority
• Ability to maintain and leverage relationships with KOLs/experts in the field
• Excellent knowledge of Ophthalmology/Ophthalmic Surgery
• In-depth knowledge and hands-on experience of post-market clinical studies, including study design, to support in-market products
• Awareness of AP Regulatory, legal, and reimbursement environment
• Good knowledge of study execution, pharmacovigilance, medical monitoring
• Sound knowledge of study publication processes and publications
• Innovative with the ability to coordinate and drive a complex and changing environment
• Ability to work effectively in a matrix environment
• Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
• Awareness of and adherence to Johnson & Johnson Credo values
Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, and Deliver as noted below:
• Connect - foster strategic partnerships with team members and key internal stakeholders to ensure success of programs in region
• Shape – build strong relationships with KOLs and external stakeholders to shape and influence relevant policies
• Lead – drive medical/clinical strategy in region and serve as project champion to ensure timely and expert support for product launches and in-market products
• Deliver – drive accountability and completion of key project deliverables aligned with regional and global strategy
III. Minimum education and experience required for competent performance:
• MD or equivalent degree in Ophthalmology required
• 5+ years ophthalmology experience or relevant field required
• Ophthalmic surgery experience preferred; Industry experience a plus (Medical Affairs and/or Clinical R&D)
• Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP)
• 2+ years experience with design and conduct of clinical research studies
• Strategic & tactical Clinical and Business knowledge to gain approval and ensure maintenance of legal marketing status of all products
• Strong communication, organizational and interpersonal skills
• Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met
• Fluence in Chinese and English language required
• Location in China required
• Role will have > 50% travel
SUPERVISION / AUTHORITY
VII. Indicate below by placing an X next to the level of responsibility, if any, for directing the work production of others. This level of responsibility must be a reflection of the job itself, not the specific incumbent (select one).
A. Give no supervision to others.
B. Have lead responsibilities for one or more employees.
C. Responsible for work flow production, training of new employees on covered jobs, answering job-related questions in one or more areas.
X D. In addition to "C", assist in reporting on performance, recommending advancements, implementing new or changed procedures. Generally recognized as Group Leader or Assistant Supervisor.
E. Have full, direct supervisory responsibilities for a department or function.
VIII. SUPERVISOR COMMENTARY: It is important that you review each position description thoroughly. Please indicate below by placing an X by the paragraph which most closely reflects the degree to which supervisory control is exercised over the performance of the job:
A. How work is done and work progress are checked under close supervision and/or clearly defined procedures.
B. Under supervision, carries out general instructions in accordance with standard practice. Requires some initiative and judgment. Actions checked periodically.
C. Under general supervision, works within established guidelines and has flexibility as to method, priority and timing of job duties. Requires some amount of initiative and judgment.
X D. Under general or minimum supervision, performs duties in terms of stated objectives. Generally works out details within broad guidelines and exercises considerable initiative and judgment.
AMO (Shanghai) Medical Devices Trading Co., Ltd. (7076)