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Latest Jobs
11 listing(s) available.
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21 Aug 2019
Product Specialist / Senior Product Specialist (Medical Device / Pharmaceutical)
Malaysia
Permanent PositionCalling all Healthcare talents within the industry to explore some of the positions offered by reputable MNC healthcare organizations, our client base would include Pharmaceutical and Medical Devices companies, as well as Life-Sciences and Diagnostics modality.Job Description
- Responsible for product promotion (i.e. Pharmaceutical Drugs/ Medical Devices/ Life-sciences and Diagnostics) to the relevant sectors (Hospitals and Medical Professionals).
- Able to travel and cover at least one outstation (to be confirmed)
- Initiate sales and/or marketing activities, also to ensure timely achievement of company's sales objectives.
- Build strong customer relations through excellent customer service and work closely with healthcare professionals to develop and penetrate the market.
- Brand awareness and product knowledge.
- Organize professional support programs and workshops, as well as CMEs.
- Effective execution of promotional strategies and sales plans in line with the company business obejctives.
- Responsible for product development, product launch / campaigns as well as to grow the market to maximize business outcomes.
- Develop and maintain new and existing client base.
Expires on 20 Sep 2019Requirements
- MUST HAVE min 1 to 2 years experience (sales) within Healthcare industry (i.e. Medical Devices/ Pharmaceutical/ Life-Sciences/ Diagnostics).
- Bachelor's degree in Biotechnology, Biomedical or related.
- To be based in EITHER ONE: Kuala Lumpur, Penang and Johor.
- Added advantage for candidates who can start work within less than a month or immediately.
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26 Jul 2019
Sales Strategy & Operations Analyst
Malaysia
Permanent PositionMultinational Healthcare Company located in KL with nearby public transport.Job Description
- Analyze market and clinical information to provide advice and guidance on sales strategies.
- Assess sales achievement and other key metrics by integrating and blending quantitative and qualitative data from a variety of sources to perform complex analyses. Interpret analyses, draw conclusions, and prepare and facilitate presentations on findings on trends (e.g. sales growth, market trends) to sales management and internal stakeholder team.
- Analyze variables and develop models on different strategic deliverables which may include annual management process cycle.
- Generate standardized reports on sales information to track attainment of growth objectives, e.g., sales results, historical growth, market growth trends, budget variance, sales exceptions and product use
- Interview and survey sales team to investigate and identify best practices and business trends to as part of strategic decisions.
- Maintain up-to-date and accurate sales results and other key metrics in applicable reporting systems. Monitor data integrity on sales dashboards and provide user support to the field for sales tools.
- Identify opportunities for innovations in sales tools, present recommendations, and develop specifications for approved tools, as well as training users.
- May contribute to the development of strategic and tactical input into the development of customer agreements/contracts (e.g. pricing, consignments, new technology introductions, increasing par levels), and interact with customers to address customer contractual concerns.
- Respond to inquiries and requests from field sales team; train users.
- Other incidental duties assigned by Leadership.
Expires on 25 Aug 2019Requirements
- Bachelor’s degree in Computer Sciences, Information Technology or Business Administration (or equivalent/relevant fields)
- 5 years’ experience in a medical device/healthcare industry or regulated industry is required
- Good data consolidation, crunching and analytical skills
- Good competency in utilizing & implementing SalesForce.com
- Good written and verbal communication skills and interpersonal skills including negotiating and relationship management skills
- Strong analytical and problem-solving abilities
- Strong business strategic thinking, interpersonal skills, and conflict management skills
- Good knowledge and understanding on financial terms will be beneficial
- Proven expertise in usage of MS Office Suite (MS Excel & MS PowerPoint is critical)
- Ability to understand business acumens, strategies, tactics and implement measurable plan
- Ability to adapt to new technologies
- Ability to adapt to rapidly changing environment
- Ability to work independently and be proactive
- Strict attention to detail
- Ability to build and maintain strong relationships across the organization
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- 20% of time traveling within the SEA region
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17 Jul 2019
Sr. CRA/ Lead CRA
Taiwan
Permanent PositionOur client is focused on the development of innovative new therapies to improve the world’s health. They do this by providing a suite of groundbreaking biopharmaceutical development services that help customers across the globe transform scientific discoveries into new treatments for patients. From clinical trial design to regulatory and consulting services to commercial and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.Job Description
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider associations
- Identify operational efficiencies and process improvements
- Develop country level informed consent forms
- Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
- Participate in bid defense meetings
- Per the Clinical Monitoring/Site Management Plan
- Verifies required clinical data entered in the case report form is accurate and complete via review of site source documents and medical records
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
- Verifies site compliance with electronic data capture requirements
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead, or operational line manager.
- For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:
- Site support throughout the study lifecycle from site identification through close out
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection
- As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
- Identify and communicate out of scope activities to Lead CRA/Project Manager
Expires on 07 Sep 2019Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Fluent in English
- Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
- Ability to manage required travel of up to 75% on a regular basis
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05 Apr 2019
Global IT Infrastructure Project Manager
Singapore
Permanent PositionIn view of business expansion, our multinational Healthcare client is seeking an IT Infrastructure Project Manager for global greenfield IT Infrastructure projects implementation.Job Description
- Responsible for driving the successful delivery for Infrastructure core technology projects and end user computing projects.
- Leads all the technical projects from initiation through implementation
- Be responsible for project plans, execution, tracking and delivery
- Drive the requirements gathering, defining functional/systems dependencies and managing the system/(s) implementation.
- Responsible for the supervision of work stream leads and to ensure that all projects are delivered within the defined scope, quality, time and cost requirements.
- Interfaces with all areas affected by the project including end users, cross functional departments, external consultants and key stakeholders.
- Work with global PMO to ensure projects execution follows and adhere to project delivery methodology
Expires on 23 Aug 2019Requirements
- Bachelor Degree in Computer Science, Information Technology or equivalent
- PMP Certification
- 5 years of IT Infrastructure Project Management experiences
- Must have project experiences in Microsoft Office 365 and Microsoft Azure.
- Preferred candidates with Global or Regional Project Management experiences
- Strong communication and social/team dynamic skills
- Ability to work well in a team environment and develop working relationships with IT functional areas through
- Strong analytical and problem solving skill.
- 2 Positions available
Office Location: Across Singapore
Kindly indicate your current/last salary details and your notice period
Interested candidates kindly forward your CV to edysusanto@peoplesearch.jobs (Edy Susanto, Reg No:R1443337)
Feel free to forward this great opportunity to someone who would be a great fit for this role.All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.
PeopleSearch Pte Ltd
EA License No: 16S8057 -
16 Feb 2019
信頼性保証部門/品質保証部/インフォメーションマネジャー
Japan
Permanent Positionアメリカ系製薬企業 - 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製薬企業です。Job Description
概要 (High-level Description; including manage team/individuals or not)
・ 安全性情報資材（市販後調査結果報告、添付文書改訂関連資料等）及び品質関連情報資材に関わる作成及び管理プロセスを最適化する。
・高品質な安全性情報資材（市販後調査結果報告、添付文書改訂関連資料等）及び品質関連情報資材を提供することにより、BMSKKのビジネスに貢献する。
・ 社内外ステークホルダーとの効果的なコミュニケーションを通じ円滑なオペレーションを行う。
役割 (Roles & responsibilities)
・ 製品毎の戦略、国内外の規制要件であるGQP、GVP等及び社内手順書（GQP-SOP、GVP-SOP、Global SOP）に従い、高品質な品質関連情報資材ならびに安全性情報資材（市販後調査結果報告、添付文書改訂関連資料等）を提供するよう監督する。品質関連情報、添付文書／使用上の注意改訂のお知らせの資料作成、配布指示等を行う（以下に記載）。
・ 品質関連情報のお知らせの資料
・ 添付文書/使用上の注意改訂のお知らせの資料
・ 患者向医薬品ガイドの資料作成
・ 市販直後調査結果報告等の資料作成
・ 医療関係者向けweb siteに掲載する安全性情報の資料作成
・ 市販直後調査の計画を立案し、実施計画書の作成
・ 営業部門及びIT部門と連携し、市販直後調査を実施
・ 市販直後調査実施報告書の作成、提出
・ 薬事部門と連携し、一部変更申請や公知申請にあたり、市販後データの提供、資料作成
・ 厚生労働省、PMDA、東京都、提携他社のPMS部門、医療関係者等の社外のステークホルダーとの情報伝達関連業務に対応する。
・ 品質情報及び安全性情報伝達業務を円滑かつ効率的に遂行する。
・ 安全管理業務を独立して実施する。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 表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: 08011184497
nagai.m@peoplesearch.jobsRequirements
必要な知識/スキル (Required knowledge/skills)
1. Behavioral Skills （行動特性）
以下の良好な行動特性を有する人材である
・ コミュニケーション
・ ネゴシエーション
・ リーダーシップ ビヘイビアの理解とそれに基づく行動能力
2. Technical Skills （テクニカルスキル）
・ 国内規制（GCP/GVP/GPSP）及び欧米のPV規制に関する知識
・ 製品/治験薬に関する基礎知識
・ 当局から発出される通知の内容を理解できる。
・ 添付文書作成等の経験
・ 査察対応の経験
・ 業務遂行のための情報収集及び課題設定、改善提案能力
・ 照会事項対応を含めた当局対応の経験
3. Experience （職務経験）
・ 3年以上のGVP/GPSPに関わる推進業務あるいはこれに類する業務の経験
・ 添付文書作成及びそれに付随する情報伝達業務の経験
・ 新薬製造販売の承認申請の経験
4. Education／Certification （学歴／資格）
・ 理系大学の学士、または修士
・ 薬剤師免許があることが望ましい
5. Language （語学力）
・ 業務上必要となる英語・日本語での文書作成能力及び口頭でのコミュニケーション力 -
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