Japan Study Manager Job at Pfizer (Tokyo)

Global Study Manager

Global Study Manager – This position is a fully client-embedded role, dedicated ...

Location

Poland

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

Bachelor’s degree: life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
Must have proven experience from study feasibility to CSR
Must have at least Ph II and PIII experience – PI & PIV is an asset
Must have cross-functional leadership proven experience, able to drive internal and external meeting
Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
Strong experience in clinical budget management
Strong experience with vendor management including CRO

Job Responsibility

Accountable for delivering the clinical operation activities of the study until study archiving
Generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality
Accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overall study deliverables
Accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendors Oversight Plan, Investigator/CRA Meeting Set Up & associated training, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Safety Management plan, eTMF & vendor set -up
Proactively and effectively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Responsible for operational input into protocol and informed consent form development, and other key study documents
Leads and conducts investigator meetings and other study related meetings

Fulltime

B2B Marketing Manager - Japan

To accelerate our B2B growth in Japan, we’re seeking a B2B Marketing Manager - J...

Location

Japan , Tokyo

Salary:

Not provided

Speak

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Marketing, or a related field
7–10 years of experience in B2B marketing, preferably in SaaS or tech
Proven success in event planning, campaign execution, and cross-functional collaboration
Strong written and verbal communication skills in Japanese
Excellent project management and multitasking ability
High attention to detail and results-driven mindset
Business-level English proficiency

Job Responsibility

Identify and build relationships with key HR/HRD partners, influencers, and associations in Japan to drive co-marketing and thought leadership initiatives that support lead generation goals
Plan and execute offline events such as industry conferences, partner-led sessions, and proprietary Speak-hosted seminars, managing logistics, vendor coordination, and post-event nurturing
Collaborate with Sales and Customer Success teams to create sales collateral, case studies, and campaigns that enhance customer engagement and retention
Run localized digital campaigns and experiments across multiple channels, executing nurture workflows and ABM campaigns in HubSpot to move leads through the funnel
Maintain and optimize the Japan B2B website for strong localization and conversion performance
Track and analyze campaign results, share insights for ongoing optimization, and stay up to date on HR tech and B2B marketing trends in Japan

What we offer

Join a fantastic, tight-knit team at the right time
Do your life's work with people you’ll love working with
Global in nature
Impact people's lives in a major way

Fulltime

Japan Regulatory Strategy Manager

Amgen is a global leader in biotechnology with a history of more than four decad...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
Advanced degree preferred
In-depth regulatory experience
Knowledge of Japan legislation and regulations relating to medicinal products
Knowledge of drug development Scientific/Technical Excellence
Teamwork
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Ability to lead effective teams
Ability to work in matrix environments including cross-functional and global teams

Job Responsibility

Developing and executing the regulatory strategies and plans
Providing strategic regulatory expertise for drug development
Interfacing with regulatory authorities
Aligning with key cross-functional partners
Integrating into Amgen's commercialization process
Continuously improving business processes
Developing and implementing the Japan regulatory strategy, aligned with global regulatory strategy
Providing guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influencing developing the global regulatory strategy so that Japan developments are aligned
Consistently looking for opportunities to accelerate the developments/approval and/or increase the value of the program

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Japan Regulatory Strategy Manager

Japan Regulatory Affairs provides leadership, expertise, and execution for the r...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
In-depth regulatory experience
Knowledge of Japan legislation and regulations relating to medicinal products
Knowledge of drug development Scientific/Technical Excellence
Teamwork
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Ability to lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy

Job Responsibility

Develops and implements the Japan regulatory strategy, aligned with global regulatory strategy as much as possible
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy so that Japan developments are aligned
Consistently look for opportunities to accelerate the developments/approval and/or increase the value of the program to serve for more patients
As a representative of the Japan Regulatory Strategy Group, contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan according to the filing plan
Ensures that regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
Ensures that local labels are developed and maintained in line with local regulations and Amgen standards and procedures
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

New

Intern, Area Operations, Revenue Strategy, Sales & Distribution

Marriott International offers students the opportunity to find an internship tha...

Location

Singapore , Singapore

Salary:

Not provided

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Excellent oral and written communication skills
Excellent analytical and critical thinking skills, result-oriented nature
Self-starter with strong problem solving skills
Detail-oriented and deadline-sensitive
Take initiative and act quickly to support and deliver projects in a professional manner
PC skills- MS Office programs (Strong in Excel. Basic knowledge of Word and PowerPoint)
Team player who has the ability to work with external parties and with all levels of the organization
Bachelor’s degree in business administration, finance and accounting, statistics or hospitality management preferred
Core education in financial studies must include investment analysis, marketing studies, international business, business laws, and managerial finance
Singaporean, Singapore Permanent Resident Holder or valid student pass / work holiday pass

Job Responsibility

Assist in data collection and analysis for various Commercial Strategies related projects from sales distribution
Assist in the preparation of various reports and power point presentations
Coordinate, track and manage project implementation for selected revenue strategy initiatives
Conduct analysis, synthesize information and provide input on specific business issues/ priorities
Participate as an active member of the team and seek ways to cross-pollinate best practices/ suggest improvements
Support/drive adhoc projects as needed

Fulltime

Senior Strategist

At AKQA (part of WPP) we believe in the imaginative application of art and scien...

Location

Japan , Tokyo

Salary:

Not provided

AKQA

Expiration Date

Until further notice

Requirements

Extensive experience in strategic planning within a digital or integrated agency environment
Experience building robust integrated comms plans
Broad knowledge of sector experience - Having experience of two or more industry sectors, with some multi-channel media experience
A gifted factual storyteller with one foot in the now and one foot in the future
Excellent communication skills and the ability to influence and inspire people
Be willing to use your experience to sharpen and strengthen team skills
Have experience in developing cutting edge brand experience platforms
Demonstrate a deep understanding of data, trends and insight, and how these may be utilised in order to improve clients' business results
Able to sport the kernel of an idea, experienced in judging the quality of ideas
Fluent in Japanese and English, both written and spoken

Job Responsibility

Develop insights from research
Manage associate research and performance evaluation programmes
Develop strategic responses and value-add thought leadership to clients
Generate local insight and strategy that resonates within Japan as well as for audiences more globally
Keep abreast of cultural, creative and technological news and developments
Utilise experience to develop macro perspectives on consumer & brand issues
Own the strategic debate on own brands
Have comprehensive understanding of business matters with senior clients
Lead debate with clients on effectiveness of new channels
Create case studies and Effectiveness Award submissions

Fulltime

Ldl (Oncology)

Provides leadership, oversight and manages the activities of within-country oper...

Location

Japan , Akasaka

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, or a related field
At least 3 years of experience in clinical operations or study management
R&D Experience and knowledge in Oncology areas
Strong knowledge of GCP, ICH guidelines, and local regulatory requirements
Proven ability to manage complex clinical studies across multiple geographies
Excellent communication and leadership skills, with the ability to collaborate effectively
Fluency in Japanese and English (Japanese: JLPT 1 level and English: TOEIC score of 800 or above is required)
Master’s degree in a science-related field
Advanced knowledge of drug development processes and clinical trial operations
Ability to lead cross-functional teams and manage external partnerships

Job Responsibility

Leads the local study team consisting of within-country clinical operations team members, cross-functional experts, vendor staff and external clinical site staff
Serves as the operational point-of-contact between the central GSK study team and within-countr(ies) study team
Accountable for within-country delivery of assigned studies to time, budget and quality expectations
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved
Accountable for the accuracy of study systems, including completeness of the trial master file
Identifies and resolves or escalates issues and risks that may impact study delivery
If needed, may provides feedback on performance, capabilities and competencies of local study members
Has the accountability to estimate, track and deliver against the local budget for the studies
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations
As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority and local Ethics Committees

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

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Japan Study Manager

Job Description

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