Job Opportunity

Job Description

Roles & Responsibilities
/Develop and execute medical strategy and tactics that can address unmet medical needs as well as aligned with business needs for the portfolio of focus
・　Drive medical strategy through partnership with cross functional teams
・　Drive growth by creating key opportunities depending on product stages
・　Plan and conduct company-driven medical research including clinical study or database study, etc. for the purpose of understanding the real-world medical situation and contributing to advancement of healthcare
・　Manage/operate Investigator Initiated Trials in accordance with relevant laws and regulations
・　Provide medical scientific input in the business development opportunity assessment
・　Ensure medical / pharmaceutical validity of promotional activities by reviewing promotional materials, training materials, FAQs and presentation slides at company-sponsored seminars.
・　Respond to medical queries from customers in a proper and timely manner in cooperation with Medical Information
・　Ensure appropriate benefit/risk assessment and risk minimization of the assigned product from medical/scientific point of view
・　Make an effective partnership with Global/Regional colleagues to drive medical initiatives
・　Enhance compliance in collaboration with relevant departments at Viatris
・　Support the manager to build the fit-for-purpose medical organization
・　Manage the budget of own projects

Required Skills and Knowledge

・Master’s degree or higher (It’s not mandatory if candidate has the licenses of Medical doctor or Pharmacist)
・Have more than 5-year experiences in Pharma industry (favorable in Medical or Clinical division) or equivalent experiences
・English and Japanese communication skill sufficient for presentation and discussion in meetings and e-mails
・Medical/pharmaceutical expert knowledge of relevant therapeutic disease area/ products, capable of medical discussion with relevant departments and external stakeholders
・ Understanding in compliance and relevant laws/regulations in the pharmaceutical industry and advocates the appropriate use of the products

Job Description

As a Regulatory CMC Manager, required to possess specialized knowledge and experience in Japanese CMC regulations. Would be responsible for formulating CMC regulatory strategies and handling approval applications for Viatris’ development products (both generic and new drugs). Additionally, required to manage CMC change control for existing products and conduct due diligence for new products as a CMC regulatory representative. By collaborating with both Japanese and global teams, This position is expected to contribute to projects as the CMC regulatory representative, aiming to deliver Viatris products to patients as quickly as possible.

Required Skills and Knowledge

BA degree or above
Over 5 years of experience in writing the CTD Quality sections (M2.3S and M2.3.P) for pharmaceuticals (both generic and Brand Products).
Business-level proficiency in English and Japanese

Job Description

GQP Compliance Group, as Quality Assurance Department, contribute to business by concluding appropriate quality agreements with suppliers such as pharmaceutical manufacturing sites, we provide an environment where the Quality Assurance Department can smoothly interact with suppliers, contributing to the stable supply of high-quality pharmaceuticals to patients.

Using expertise in GQP and GMP regulations, as a Quality Assurance professional, this position would manage following tasks

Be responsible for concluding and revising quality agreements and quality contracts with domestic and international manufacturers, and perform appropriate GMP management tasks.
Perform document management tasks related to GQP ordinances (creation and revision of SOPs).
Execute or oversee other tasks related to quality assurance.

Required Skills and Knowledge

BA degree or above in Science
Over 5 years of experience in QA/QC within the pharmaceutical industry, specifically related to GQP/GMP/GDP.
Practical experience in negotiations and dealings with external manufacturers and suppliers, including those overseas.
Experience in agreements, contracts, and document management tasks.

Click on "APPLY" to open the entry form, fill in the necessary information and submit it.

Please prepare a resume (profile information such as name, address, educational background, work history, qualifications, etc.) and a detailed work history (including achievements, acquired skills). If you wish to apply for a position that requires English, please also prepare a detailed work history in both Japanese and English.

We will guide you to our head-office or a nearby venue.

Viatris is actively offering jobs to people with disabilities. Please feel free to contact our recruiting department.