Senior Medical Affairs Manager

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.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

Scientific/Technology

All Job Posting Locations:

Shanghai, China

Job Description:

General Summary（基本概况）

The purpose of the position is to strategically provide scientific guidance and support to business activities publication and internal/external customers.  

Responsibility (工作职责)

Publication Lead In Electrophysiology Area:

• To lead the publication strategy of company sponsored studies, collaborative studies and pre-clinical studies, and ensure data published in a scientific way.
• To provide guidance to medical writers on the manuscript outline, results interpretations and discussions parts, review and be responsible for final publication.
• To provide scientific insights to study designs of company sponsored studies, collaborative studies and pre-clinical studies from publication perspective.
• To be familiar with Electrophysiology Journals and keep updated to the latest keys evidence in Electrophysiology area and identify the advantages and limitations and summarize publication experience.

External scientific liaison: To develop and maintain professional and scientific relationships with external Electrophysiology experts, in accordance with the company strategy to further understand and gain both insight and/or input into treatment/evidence gaps.

Ebm Training Support:

• To provide training courses in the EBM training on the topics of latest evidence advancement and publication experience sharing based on the summarization.
• To collect investigators’ proposals (IIS) for local and regional clinical activities，to ensure that these proposals are discussed within the local clinical trial review committee, to coordinate Global Franchise approval processes, and to provide timely feedback to investigators. Coordinate and track the progress on contracting, project conduction and reporting after IIS approval.
• To develop and maintain professional relationship with external experts, in accordance with the company strategy to further understand and gain both insight and/or input into treatment patterns，including the scientific activities taking place within the disease area，and the needs and behaviors of healthcare professionals.
• To provide strategic medical support to the clinical research operation team on medical activities relating to the conduct of a trial or survey，e.g. protocol preparation, safety review, study report writing and publication. Maintain scientific contacts with local investigators.
• To 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 plan and proposal, evidence publication and dissemination, and other related activities.
• To partner with other functional stakeholders, to prepare Clinical Evaluation Report to support product registration.
• To develop an understanding SOPs and proper working instructions to ensure the internal process are in compliance with company policy and related regulation, if applicable.

Principle Relations (inside & outside company) 主要工作关系 (公司内部和外部)

• Clinical research team in China, regional, global and source companies
• Medical affairs team in China, regional, global and source companies
• Regulatory affairs team in China, regional, global and source companies
• Quality assurance team in China, regional, global and source companies
• Clinical Quality Control/Assurance team in China, regional, global and source companies
• Business team, incl. marketing, sales, ProfEd and training
• R&D team in China, regional and source companies
• Finance business partners
• Professional Education team
• Health Care Compliance team
• Clinical research organizations, global, regional and local
• Key opinion leaders and investigators
• China health authorities, incl. China and provincial food and drug administrations

Personal Requirements ( include experience, knowledge，skills and education)

• At least master degree of medicine, 公卫，统计，bio-engineering or life science
• At least 4-5 years’ experience practicing medicine or product develop research experience
• At least 3 publications experience as first author on international journals
• Industry experience in academic/research institute, pharmaceutical development marketing
• Clinical operation, or medical affairs would be preferred.
• Good communicate and written skills in English, both orally and in writing
• Having good co-operation abilities and a positive character