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21 Dec 2018
17 Dec 2018
【GCP監査：Regional Clinical Compliance Lead 職】新宿勤務
JapanPermanent Positionブブリストル・マイヤーズ スクイブ株式会社は、深刻な病気を抱える患者さんを助けるための革新的な医薬品を開発し、提供することを使命とするグローバルなバイオファーマ企業 ブリストル・マイヤーズ スクイブ米国本社の日本法人です
This role will report to the Head of Regional Clinical Compliance APAC who is a member of the Global Clinical Compliance ＆ Continuous Improvement （GCC＆CI） leadership team under Global Clinical Operations （GCO） based in Japan. This role is also based in Japan.Expires on 16 Dec 2019
Posted ByMiki Nagai (備考 Rich GCP related experience English（MUST) Grade: D6-D7 depending on candidate qualifications and experience Speed / Agility / Flexible thinker D6 role will cover Japan/Korea/Taiwan D7 role will cover all of APAC area (supporting head))
Bristol－Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol－Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease.
This role will report to the Head of Regional Clinical Compliance APAC who is a member of the Global Clinical Compliance ＆ Continuous Improvement （GCC＆CI） leadership team under Global Clinical Operations （GCO）. Responsibilities will include:
In partnership with the Regional Clinical Operations and Global Quality,
Support the regional study teams and sites to assure inspection and audit readiness at all times.
Lead the implementation of the Quality Audit Plans with on－site support prior to, and during internal audits.
Coordinate site and sponsor inspections by Health Authorities as necessary.
In partnership with the Regional Clinical Operations teams, provide appropriate continued oversight to study teams.
Work closely with the Clinical Quality and Risk Management team and help implement elements of the Quality Management System: identify emerging and significant risks, provide support for root cause analyses and mitigation strategies, ensure documentation and appropriately notify/escalate to the right level of Governance.
Provide CAPA leadership by coordinating CAPA development and approval, as well as implementation and tracking of effectiveness.
Partner with the Clinical Training, Process and Continuous Improvement organization to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed.
As the scope of Global Clinical Operations includes registrational and non registrational data generation （NRDG）, regional clinical compliance activities will span across Phase I through IV studies including Investigator－Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical.
Work with management and Global Quality to foster a regional, cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.
A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years of experience in clinical trial operations and/or Good Clinical Practice is required. Fluency in a second language relevant to the geographical scope is a plus.
Good understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
Experience in matrix management and training is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders （in various functions and geographies） as well as external stakeholders （including Health Authorities）. Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
Ability to manage multiple projects simultaneously to ensure timely, on－budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
The candidate will demonstrate the ability to adopt a biopharma enterprise－wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.
This role will require significant domestic and international travel up to 50％.
07 Dec 2018
Assistant Brand Manager
MalaysiaPermanent PositionAn established MNC company specializes in beauty and personal skincare products and carrying one of the world’s largest skin care brands.
- Effectively manage the assigned category segment by leading brand development plan & strategy, revenue growth management strategy, research and insights, future category opportunities and integrated marketing communication activation in support of the direct line manager and aligned with total company growth objectives and strategic roadmap.
- Play an important contributing role to build commercial team capabilities, operating effectiveness, team spirit, and collaborative culture across the marketing Team and within the organization.
- A&P planning & spending, product price margin analysis, product launch demand forecast planning, annual budget planning process and budget reviews
- Marketing Strategy Develop short term growth strategies. Ability to take initiative to identify key opportunities and gaps on top of deeply understanding via analysis of the competitive landscape.
- Consumer Understanding
- Comprehend and able to identify a competitive potential insight that is unique and opportunistic and executing actionable plan set by line manager.
- Media & Communication Plan
- Execute plan of A&P spend for product’s ATL communication, working together with Media Manager to ensure timeliness.
- Marketing Launch Plans
- Develop consumer marketing launch plans for all new product innovations, product re-launches or category thematic P1 campaigns as assigned by line manager, in a timely and accurate manner.
- Lead point of contact for cross functional team on providing information, planning, task segregation for the campaigns.
- Key point of contact to manage external agencies/ business partners to meet the campaign deliverables.
- Market Research
- Execute and value add to research projects planned in support of line manager
- Brand Image & Brand standard
- Implement brand guidelines and act as key gatekeeper for all product brand equity materials communicated internally and externally
- Finance & Budgeting
- Financial savvy – able to comprehend P&L and seek opportunities to continuously improvement cost efficiency.
- Accountable for product segment A&P spending, product price margin analysis, product launch demand forecast planning, annual budget planning process and budget reviews.
- Team management
- Inspiring, motivate, coaching, develop cross functional team to deliver business objective.
- Self-initiative to own career development plan.
- Courage & actively give and seek for feedback from line manager and colleagues.
Expires on 08 Sep 2019
- Update Direct Line Manager on the status of the principle accountabilities on bases of internal and external information: market research for brand image, usage, market share.
- Demonstrate the highly effective communication within the cross-function (with SCM, CD team, Retail team, Regulatory, Supply Chain, Regional Marketing, Finance) to ensure the highest business result achieved.
- Complete standard monthly reporting templates as required by category assigned in timely and data accurate manner.
- To perform any ad-hoc duties assigned from time to time.
Posted ByEmily Poh
Tel: 012 222 4616 (WatsApp Available)email@example.com