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118 listing(s) available.
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16 Feb 2019
【研究開発本部バイオメトリクス】 Project Statistician （担当/担当課長/専門課長）
Japan
Permanent Positionアメリカ系製薬企業 - 1876年に創業、140年を超える歴史がある。米国インディアナ州インディアナポリスに本社を置く、革新を追求する医薬品のリーディング・カンパニーです。世界各国の自社研究施設や外部の優れた科学的研究機関との提携による最新の研究成果を用いて、各治療領域で最高レベルの豊富なポートフォリオの医薬品を開発しています。世界120ヵ国以上で事業を展開しています。Job Description
【職務概要/Overall Job Purpose】
Provide strong statistical leadership in the process of drug development.
The Project statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.
【主な職責/Primary responsibilities】
Statistical Trial Design and Analysis
● Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
● Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
● Collaborate with data management in the planning and implementation of data quality assurance plans.
● Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
● Participate in peer-review work products from other statistical colleagues.
Communication of Results and Inferences
● Collaborate with team members to write reports and communicate results.
● Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
● Respond to regulatory queries and to interact with regulators.
Therapeutic Area Knowledge
● Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
● Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.Expires on 18 Dec 2019Posted By
Miki Nagai ((少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書（英語版、日本語版でも可）を 下記のメールアドレスまでご送付いただけますとスムーズです。) Tel: 080-1118-4497 nagai.m@peoplesearch.jobs)Tel: 080 1118 4497
nagai.m@peoplesearch.jobsRequirements
【必須経験（Required Experience (mandatory for hiring)】
◆ M.S. or Ph.D. in statistics or biostatistics.
or
◆ Rich experiences in healthcare field as a statistician with science background such as mathematics or epidemiology.
◆ Ph.D. more preferable
【望ましい経験/Desirable Experience】
◆ Experiences of collaboration with team outside of Japan (preferred: overseas living experience)
【必須応募資格/Essential skills and license (mandatory for hiring)】
◆ Statistical and methodological knowledge in clinical development, epidemiology or related field.
◆ Regulatory knowledge of clinical trial methodology and statistics.
◆ Ability to build relationships with individuals and teams.
◆ Strong English and Japanese communication and presentation skills
【望ましい資格/Desirable skills and license】
◆ Proficient in the SAS programming language -
14 Feb 2019
Director, Legal & Compliance
Japan
Permanent PositionMSDは、グローバルヘルスケアリーダーMerck ＆ Co., Inc., Kenilworth, N.J., U.S.A.の一員として、日本の皆さまに医療用医薬品やワクチンをお届けし、革新的なヘルスケア・ソリューションを提供しています。強固なパイプラインと世界140カ国以上で事業を展開するグローバルなネットワークを活かし、未だ満たされていない日本の医療ニーズに積極的に応えていきます。Job Description
Position Overview - Basic Functions & Responsibility
The primary responsibility of Director, Legal & Compliance, is to provide legal & compliance consultation, guidance, advice and support to all divisions of the Company in Japan (“MSD Japan”), and to take a strong interest in understanding and implementing the Company’s compliance standards and managing compliance issues across all divisions. As a member of the Japan Legal & Compliance team and the broader Asia Pacific, China & Japan Legal & Compliance team, the individual shall handle legal matters and compliance issues arising from the Company in Japan, as directed by and under the supervision of the Executive Director, Legal & Compliance – Japan, collaborate closely with the Internal Control Officers (“ICOs”) of various functionsof MSD Japan, and work in conjunction with Regional and Global Legal & Compliance colleagues, external counsel and relevant headquarters and subsidiary staff and functional groups, as needed.
Primary Activities – Accountabilities, Supervision,
Primary activities include, but are not limited to:
•Guide, monitor and assist with all activities of MSD Japan’s business that require legal/compliance input, and ensure all corporate, regional and local legal mandates and compliance objectives and goals of MSD Japan are met, with quality, collaborative and timely advice and oversight given to clients by both internal and external legal resources
•Provide sound, appropriate and timely legal and compliance advice and oversight on proposals for new or revised initiatives/programs in MSD Japan, including but not limited to, patient programs, marketing initiatives, and other commercial proposals
•Collaborate with and provide guidance/support to each function in MSD Japan in the performance of their tasks and enable effective monitoring of compliance and related matters on behalf of MSD Japan
•Work with Country Leadership Teams (“CLT”) of MSD Japan, as needed/directed, on risk assessments and implementation of continuous improvement on risk controls, provide insightful and strategic advice on business undertakings within the local and corporate compliance framework, and participate in meetings with the CLT as needed
•Act as a resource and subject matter expert on Legal and Compliance issues, as well as the industry and the Company Compliance standards, policies and processes for the business organization in Japan and provide coaching and mentoring as needed, to newer and more junior members of the Japan Legal & Compliance team and ICOs
•Lead or support new Legal and/or Compliance projects on behalf of MSD Japan, as directed by the Executive Director, Legal & Compliance – Japan and/or Regional/HQ Legal/Compliance management
•Support the legal needs of key stakeholders through appropriate allocation and management of internal and external legal resources, provide business and other stakeholders, including ICOs, with adequate, high quality and pertinent legal advice and compliance input to ensure that MSD Japan complies with all legislative and regulatory requirements including privacy, anti-corruption/anti-bribery, fair competition and trade practice legislations, etc., as well as MSD’s policies, compliance standards and local industry guidelines
•Assess, supervise and help manage the engagement of external legal resources in Japan and ensure that the service and advice received from external legal resources is timely, cost-effective and of consistently high quality
•Understand and adapt changes in policies by the headquarters of the Company into local guidance and policy. Adopt external code and law changes into local SOP and practices by working with industry associations and external legal counsel
•Proactively undertake and fulfill those tasks and activities designated for Legal & Compliance (“L&C”) for Japan, as shown in the Appendix, in consultation with and as directed by the Executive Director, Legal & Compliance – Japan
Company Leadership Standards applicable to the role include:
•Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data, and support them once made.
•Act with Courage & Candor - Speak openly, honestly and with conviction: have the courage to take appropriate risks and make difficult decisions.
•Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
•Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the Company.
•Focus on Customers & Patients - Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.
•Drive Results – Set clear performance standards, overcome obstacles; hold ourselves and others accountable for achieving results.Expires on 16 Dec 2019Posted By
Miki Nagai (Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書（英語版、日本語版でも可）を 下記のメールアドレス（nagai.m@peoplesearch.jobs ）までご送付いただけますとスムーズです。) Tel: 080 1118 4497)Tel: 080 1118 4497
nagai.m@pplesearch.comRequirements
今回Complianceの方を主に担当いただくことになりますが、日本か他国の弁護士資格保有が必須となります。
Skills, Knowledge, Experience & Qualifications required:
•Admitted to practice law in Japan
•More than 10 years of post-admission legal/compliance experience
•In-house legal and compliance experience in a large multinational pharmaceutical organization and/or commercial practice experience in a top tier law firm would be advantageous. .Language proficiency with English and Japanese required.
•Ability to pro-actively identify key issues and concerns and consistently apply a high standard of integrity, professionalism, legal knowledge and expertise and business ethics to achieve satisfactory resolution of such issues and concerns
•Good knowledge and understanding of sales and marketing practices and applicable Code(s) of Conduct in the healthcare or pharmaceutical industry would be advantageous
•Familiarity with the U.S. Foreign Corrupt Practices Act, the UK Bribery Act, and equivalent anti-corruption/anti-bribery laws in Japan would be advantageous
•Strong working knowledge of privacy, competition and employment legislations highly desirable
•Strong leadership and commitment to make sound and appropriate judgments
•Ability to think broadly with the best interest of the organization in mind
•Ability to provide practical, commercially focused and value-added legal and compliance advice
•Highly developed technical and research skills, ability to work independently and good attention for details
•Ability to lead a team of lawyers, paralegals and/or compliance professionals in adequately monitoring, supervising and guiding their duties and developing and maximizing their potential
•Ability to work collaboratively and lead, interact with and influence cross functional teams and senior management in the business, and to deal effectively with a broad range of people across all levels
•Ability to design, implement, administer and advice on legal and/or compliance programs and procedures
•Ability to effectively manage workflow, competing priorities and changing circumstances
•Ability to work independently and prioritize work effectively under pressure
•Ability to work autonomously as well as within a team environment
•Strong analytical, drafting, negotiation and presentation skills, both in English and Japanese, including the ability to present to executive level management
•Strong interpersonal and communication skills (both verbal and written), including the ability to conduct training, interviews and investigations, as needed
•Technologically proficient, intermediate IT user skills
•Strong solutions focused approach to problem solving
•Proactive approach to streamlining compliance initiatives
•Ability to promote teamwork and open discussion of issues, coach and guide others
•Ability to explain difficult issues and work to build alignment around complex or challenging situations
•Proactive and responsive
•Practical approach with a “can do” attitude -
12 Feb 2019
Sr Manager,Portfolio management and Business Operations （R&D）
Japan
Permanent Position神経疾患、自己免疫疾患、希少疾患の治療法開発に重点を置く、世界屈指のバイオテクノロジー会社です。1978年に設立され、生物学的および低分子薬の発見における当社の研究が、世界で最も広範な多発性硬化症治療法のポートフォリオと、血友病患者さんのための革新的な新しい治療法へと導きました。革新における経験、能力、熱意によって、当社はパイプラインを築き上げ、重篤で治療が困難なアルツハイマー病、脊髄性筋萎縮症、筋萎縮性側索硬化症（ALS）のための可能性ある治療法の探索を含む 最先端の研究プログラムを推進しています。Job Description
Support Director of Program and Alliance management for tracking global Portfolio status and initiation of cross functional planning inJapan R&D with global RDPL/CPL. This role provides project management skills for global portfolio tracking. This job also includestracking of Japan project status, resource affordability and operational spending to deliver milestones/goals as planned. This serves arole for clerical and analytical work for budget planning and tracking.
Expires on 14 Dec 2019Posted By
Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書（英語版、日本語版でも可）を 下記のメールアドレス（nagai.m@peoplesearch.jobs ）までご送付いただけますとスムーズです。) Tel: +81 80 1118 4497 nagai.m@peoplesearch.jobs)Tel: 080 1118 4497
nagai.m@peoplesearch.jobsRequirements
<Qualifications>Life science degree (Master degree plus)Business Degree(MBA) is preferableCertified PM professional is preferableBusiness fluent English communication skill is essential<Knowledges>PMBOKDecision science
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12 Feb 2019
Government Affairs & Health Policy Director
Japan
Permanent Position米国系大手製薬企業Job Description
Government Affairs & Health Policy Director
The Government Affairs & Health Policy Director will monitor Japan Health Policy environment (policy change, new legislation, and key stakeholders’ activities), develop and implement strategy to shape a policy environment favorable to BMSKK business growth in Japan. The manager will report to the Head of Corporate Strategy Davison.
Job description
1. Build strong relationships with both internal and external key stakeholders (government personnel, legislators, politicians and key stakeholders in the industry) to discuss issues and to support the company’s policy positions and priorities
2. Monitor legislation and policy initiatives, and analyze impact on BMSKK strategic objectives
3. Communicates the above internally, providing recommendations to senior management team
4. Work closely and collaboratively with BMSKK teams (commercial, development, legal, communications, market access, pricing etc.) to shape and deliver proactive cross- company initiatives as well as respond to opportunities or manage issues that arise
5. Lead and coordinate the development and implementation of external outreach programs and advocacy plans on
Priority policy issues
BMSKK CSR activities (Pediatric Oncology project)
6. Represent the company in industry associations (PhRMA and JPMA) and contribute to their advocacy work
7. Establish strong working relationships with Global Government AffairsExpires on 14 Dec 2019Posted By
Miki Nagai (少しでも、ご興味お持ちの方はお気軽にご連絡ください。 事前に職務経歴書（英語版、日本語版でも可）を 下記のメールアドレス（nagai.m@peoplesearch.jobs）までご送付いただけますとスムーズです。))Tel: 080 1118 4497
nagai.m@peoplesearch.jobsRequirements
Desired Skills and Experience
1. Degree in law, political science, business, or communications preferred?
2. Minimum 3 years working experience in Government affairs/Health Policy function, consultancy, think tank, Government
3. Deep understanding of decision-making processes and legislative procedures
4. Deep understanding of Japan Health Policy and system, current evolution
5. Established level of credibility and strong understanding of the external stakeholders
6. Mature, adaptive and flexible disposition to effectively interact with a range of diverse external stakeholders and senior level Government Affairs & Health Policy Director executives
7. Good presence, outstanding interpersonal skills, and excellent leadership and influencing skills
8. Excellent communication/presentation skills (English and Japanese)
9. Fluent in English -
05 Feb 2019
Pricing Director
Japan
Permanent Position米国系製薬企業Job Description
A 製品の価値を最大化する薬価戦略を立案・実施するとともに、
B 監督官庁・業界団体・関係者と関係を構築し、ビジネスに影響を及ぼす情報の収集・分析と行い、BMSKKの情報を発信する。
- 新薬(開発時含む) ・既収載医薬品の薬価戦略立案と実施
- 薬価交渉及び薬価申請、薬価改定・再算定等への対応
- 制度改革等規制情報の収集と伝達
- 業界活動
- マーケットアクセスの評価、および将来動向に就いて検討
- 米国本社への説明対応
- メンバーの育成Expires on 19 Dec 2019Requirements
Experience in Pricing
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19 Jan 2019
Marketing Executive (Cosmetics/Skincare)
Malaysia
Permanent PositionA well established Japanese Cosmetic Skincare Distribution Company.Job Description
Job Responsibility
- Develop, organize and execute marketing campaigns for the assigned brand in line with brand marketing objectives and goals.
- Propose marketing strategies which combine all marketing mix such as product, pricing, positioning and promotion to achieve business plan
- Work closely with designers, suppliers and production on matters related to creation, development and improvement of marketing materials
- Responsible for providing and supporting sales team with necessary product related materials
- Ensure all retail stores visual merchandising is in line with brand primary & secondary focus
- Establish and maintain close relationship with associates such as principles, media, KOL & public
- Manage budget and calculate investment decisions within the limit of allocated budget
- Assist in the development of new/existing products and markets in order to contribute to the achievement of the business unit and marketing objectives
Expires on 15 Dec 2019Requirements
- Candidate must possess at least a Bachelor's Degree, Professional Degree
- Preferably 1 year of working experience in related field (retail/beauty/FMCG) or 3 years working experience is required for this position
- Good communication skills with pleasant personality
- Computer literate and proficient in MS Office
- Proficient in English, Chinese and Bahasa Malaysia
- Independent and organized to meet deadlines
- Thrive in a fast-paced, performance-driven and multi-tasking work environment
- Pleasant personality with good interpersonal and communication skills
- Preferably female and Malaysia citizen only