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Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care.
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Clinical Scientist, Medical Affairs Asia Pacific (based in Hong Kong)

Based in Hong Kong, at our Asia Pacific Headquarters and reporting to the Sr. Director Research & Clinical Science, Medical Affairs Asia Pacific. The roles and responsibilities expected of the position include:

1) Support the management of clinical research programs of Fresenius Medical Care Asia Pacific throughout the region with focus on medical (e.g. medical monitor and safety evaluation for clinical study, medical writing, publication, strategy of epidemiology study & data analysis, clinical evaluation of related registration product).

2) Provide medical leadership to the evaluation of pipeline and development strategy in collaborated with other functions across AP region.

3) Development and maintenance update clinical research/scientific information to support the needs of professional education program for both internal and external stakeholders.

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Based in Hong Kong, at our Asia Pacific Headquarters and reporting to the Sr. Director Research & Clinical Science, Medical Affairs Asia Pacific. The roles and responsibilities expected of the position include:

1) Support the management of clinical research programs of Fresenius Medical Care Asia Pacific throughout the region with focus on medical (e.g. medical monitor and safety evaluation for clinical study, medical writing, publication, strategy of epidemiology study & data analysis, clinical evaluation of related registration product).

2) Provide medical leadership to the evaluation of pipeline and development strategy in collaborated with other functions across AP region.

3) Development and maintenance update clinical research/scientific information to support the needs of professional education program for both internal and external stakeholders.

Your assignments

Key Areas of Responsibilities in Detail:

Leading clinical development (CD) strategy and is responsible for developing the CD plan and ensuring effective and efficient CD plan execution for the assigned products through FME AP region

  • Stays abreast of internal and external developments, trends and other dynamics to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment; reviewing and keeping updated on relevant publications as well as continuous communication and effective partnering with global and country team
  • Establishes and cultivates relationships with internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups
  • Leads CD strategy development for the assigned disease area(s). 
  • Designs and develops, or oversees others in design and development of:  clinical studies and protocols, product evaluation report and safety profiles, and other relevant materials
  • Plays a key role in the identification and selection of appropriate external investigators and sites
  • Plays a leadership role in the development of analytics and data management plans for each study
  • Plays a lead role representing FME in key investigator presentations, meetings and other communications
  • Acts as the medical monitor for each relevant study. Conducts ongoing reviews of study analytics and other data
  • Measures and monitors study progress against objectives and plans, including any variances, and proactively communicates any issues, challenges and potential strategies to resolve such.  Keeps all internal and external partners and stakeholders abreast of developments across study intervals
  • Works closely with clinical operations to close-out clinical studies, lock-down data and complete final study reporting on status and results

Developing scientific evidence and communicating with various stakeholders both internally and externally:

  • Plays a lead role in the development and implementation of communications strategies to support existing and concluded studies
  • Develops and delivers key presentations, both internally and externally
  • Drives ongoing data generation/publication plan to address medical gaps and recommend opportunities to his/her manager and others in the relevant therapeutic area of assignment
  • Be the main point of contact with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches. Maintain awareness of changes in clinical study processes across government in AP region
  • Maintain regular communication with country legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met
  • Establish relationships with KOL, other clinicians, advocacy groups and specific regulators
  • Partner with training department on the design, plan and execution of specific trainings related to respective therapeutic area

 Ensuring all Company Initiated Studies (CIS) adherence to ICH/GCP and SOPs

  • Consistently complies with, and ensures the same among relevant study team members, all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines, as these collectively guide and govern FME’s design, implementation, management, conclusion and reporting of clinical development studies and other investigations

Providing medical leadership to evaluation of pipeline and generation of the marketing strategy for the relevant product

  • Providing medical inputs to the evaluation of new product pipeline in collaborated with other functions across AP region
  • Providing medical input to the creation and development of marketing strategy whilst driving brand value
  • Providing medical leadership to faculty, program and content development for Advisory Boards, Symposia and KOL development

Training and development:

  • Identifies areas of best practice and process improvements

Your profile

Qualifications and Experience Required:

  • University Degree in a medical or life science-related field( e.g.public helath, pharmacy /  pharmacology, bioscience or other health science). MSc or PhD is a plus.
  • At least 2 years’ experience in clinical research/medical /scientific affairs or related function in global pharmaceutical or medical device industry, ideally in a field closely related to renal disease. There should be a constant strive for continues learning and knowledge growth. Experience of Asia country is a plus.
  • Proven experience in medical support for pre-marketing and post-marketing activities
  • Complete and expert fluency in spoken and written English is a requirement. Some degree of competence in one or more Asian languages is advantageous; understanding the cultural differences imperative.
  • Developing understanding of regulatory guidelines in a medical device and pharmaceutical research setting            
  • Experience in managing relationships with health authority or academic personal
  • Knowledge of medical information database would be preferable
  • Understand and respect cultural differences when interacting with colleagues in the other work place
  • Analytical and critical thinking skills is able to critically evaluate and solve problems, display good judgment, and maintain appropriate levels of independence
  • Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with high flexibility to a successful conclusion.
  • Good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization
  • Evident drive for results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)

Characteristics Required:

  • Analytical and critical thinking mindset
  • Interested in learning new things
  • Welcomes to solve challenging problems
  • Ability to work within a multidisciplinary multicultural team

Zusätzliche Infos

Please forward your details to hrap@fmc-asia.com if you are interested.

(Data collected will be used for recruitment purpose only. Candidates should consider their applications unsuccessful if not invited for interview within six weeks.)

At a glance

Career level:

Professional Experienced

Job category:

Medicine

Working condition:

Permanent contract / Full-time

Business segment:

Fresenius Medical Care

Location:

Hong Kong / International

Closing date for applications:

none - we look forward to your application

Your contact

  • Fresenius Medical Care Asia-Pacific Ltd.
  • Fresenius Medical Care Asia-Pacific Ltd.
  • Ref. number: 22463

About Fresenius

Career with a purpose:

Over 250,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

career.fresenius.com
fresenius.com

 

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons

 

The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits

Your contact

  • Fresenius Medical Care Asia-Pacific Ltd.
  • Fresenius Medical Care Asia-Pacific Ltd.
  • Ref. number: 22463
Career level:

Professional Experienced

Job category:

Medicine

Working condition:

Permanent contract / Full-time

Business segment:

Fresenius Medical Care

Location:

Hong Kong / International

Closing date for applications:

none - we look forward to your application

About Fresenius

Over 250,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
career.fresenius.com
fresenius.com

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons
The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits