Work Schedule

Environmental Conditions

Job Description

Helping deliver life-changing therapies

Our broad range of clinical development and analytical services enables Thermo Fisher Scientific customers to drive innovation and increase drug development productivity. Recognized for accelerating promising medicines from early development through regulatory approval and market access, our custom-tailored solutions service pharma, biotech, medical device and government organizations.

Essential Duties and Responsibilities

Provides technical and medical information, and/or performs intake of adverse events/ product complaints with quality customer service. Analyzes and researches inquiries and documents interactions according to organizational, client and regulatory guidelines. The information provided will be given to a level in parallel with the individual’s expertise, experience, and training.

Job Description

✓ Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet, or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support.

✓ Analyzes caller’s questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.

✓ Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.

✓ Maintains thorough knowledge of project and corporate policies and procedures including client products, SOPs, protocols, GCPs, and applicable regulatory requirements. ✓ Works closely with internal and external client contacts (up to and including members of client management) to resolve complex inquiries. As needed, research medical literature and drafts responses for such inquiries

Education

✓ Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Knowledge, Skills, Abilities

✓ Medical knowledge

✓ Polite Japanese Customer service skill

✓ Proficient computer and keyboarding skills Preferred

✓ Pharmacists or medical representative experience

Selling points of this position

✓ MIS play a key role in providing accurate medical information to health care professionals and/or patients/consumers; and identifying and reporting Adverse Events and Product Quality Complaints in accordance to regulatory requirements.

Career progression

✓ In Medical Communications alone, the career path that MIS may want to consider to pursue is upward mobility, i.e., from MIS I > MIS II > MIS III > Ops Manager > Associate Director > Director. Within MedComm there are likewise other career pathways such as Quality Assurance, Training, etc. Outside MedComm, Thermo Fisher offers a wide range of career growth opportunities, and we encourage and support staff through regular career conversations.

Team culture

✓ As we operate in a contact center type of environment, close team coordination and collaboration is essential because we all aim for the same business goals. We hold daily check in meetings, team meetings, one on one sessions, and engagement activities. From an expertise perspective, we look to our MIS team to share the trends and insights they observe so that these are shared in partnership to our clients.

Training

✓ During onboarding training, all MedComm new hires go through a 2-week MedComm Academy training composed of self-learning and facilitator-led sessions. New hires are trained on Departmental training during this time (Introduction to PPD and MedComm, Customer Service and Regulatory training, Procedures and Policies, Database and Telephony systems, and Product Safety Training). After the MedComm Academy, the MIS is trained on the MedComm Project specific training which provides more in depth information about the processes and products of the client program that MIS will be working on. Post the onboarding new hire training, MISs are provided regular training. Majority of the training are self-learning training, and the rest are conducted either face to face, mentor-type hands on training, or virtual training.

Interaction with global team

✓ MedComm is a global team, and most of the projects that we have in MedComm are Global Clients. There may be meetings conducted globally, be it with internal or external partners. When global meetings are scheduled, we work on a common feasible time for attendees (e.g early morning or early evening Japan time).

Company: PPD Pharmaceutical Development Japan K.K.