Taipei, Taiwan · Hybrid
Job Description THE OPPORTUNITY With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. W…
Skills: Clinical Site Management, Clinical Trials Monitoring, ICH-GCP, Regulatory Affairs Compliance, Root Cause Analysis
Hyderabad, Telangana, India · Hybrid
Job Description Specialist, Lab Execution System, Tester The Opportunity Based in Hyderabad, join a global healthcare biopharma company and be part of a 130-year legacy of success backed by ethical integrity, forward mom…
Skills: Asset Management, Benefits Management, Management System Development, Product Management, Requirements Management
Seoul, South Korea · Hybrid
Job Description 주요업무 Best registration strategy를 수립하여 신규 품목 허가를 득하고, 국내 규정 및 global compliance standard에 따라 품목허가 유지 1. 신규 제품 허가 및 적응증 확대 계획된 일정에 따라 허가 자료를 준비하고 신청식약처 및 HQ와 효율적인 communication 진행 2. 품목 허가 유지 관리 (Lifecycle …
Skills: Pharmaceutical Regulatory Affairs, Regulatory Strategy Development, Regulatory Compliance, eCTD, Pharmacovigilance
Bucharest, Romania · Hybrid
Job Description We are seeking a highly motivated Identity & Access Management (IAM) Operations Specialist to join our global Tier 2 IAM Operations team. This role supports a fast-paced, enterprise environment and is res…
Skills: Identity & Access Management, PingFederate, PingAccess, Delinea Secret Server, SailPoint IdentityNow
Guiyang, Guizhou, China · On-site
Job Description #R401277 职位描述： 在指定的区域内积极开展公司产品的介绍和推广，与医疗机构建立并维持良好的合作交流关系，确保公司下达的各项推广目标的达成，同时确保公司产品的市场占有率和增长率。 工作职责： 区域目标 在指定的区域内, 达到指定产品的目标业绩，市场占有率和增长率,并有效地利用资源和控制费用按照公司规定的医疗机构覆盖和拜访频率，制定相应医疗机构的拜访计划并实施运用适当的推广技巧和有效地利用产品资料,…
Skills: Account Planning, Adaptability, Clinical Informatics, Clinical Medicine, Collaborative Communications
North Wales, Pennsylvania, United States · Hybrid
$311k–$489k/yr
Job Description The Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead has primary responsibility for the planning and directing of clinical research activities involving new or marketed…
Skills: Clinical Development, Clinical Investigations, Clinical Reporting, Clinical Research, Clinical Trial Planning
Rahway, New Jersey, United States · Hybrid
$311k–$489k/yr
Job Description The Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead has primary responsibility for the planning and directing of clinical research activities involving new or marketed…
Skills: Clinical Investigations, Clinical Judgment, Clinical Research, Clinical Trial Planning, Consultative Approach
Boston, Massachusetts, United States · Hybrid
$260k–$410k/yr
Job Description Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Immunology Discovery Sciences and late-stage Immunology Clinical Research. W…
Skills: Clinical Development, Clinical Judgment, Clinical Research, Clinical Studies, Clinical Trials
Pennsylvania, United States · Remote OK
$79k–$125k/yr
Job Description As a Cardiovascular Disease Specialist, you will drive meaningful patient impact by leveraging our scientific expertise and serving as the primary contact for customers within your assigned territory. As …
Skills: Account Management, Adaptability, Biotechnology, Business Planning, Cardiovascular Disease (CVD)
Rahway, New Jersey, United States · Hybrid
$117k–$184k/yr
Job Description Senior Empower Technical Lead Join us and be part of our dedicated team that provides support for our Global Manufacturing Laboratories to improve efficiency and compliance while improving our CDS Platfor…
Skills: Applied Engineering, Asset Management, Biochemical Analysis, Chromatography, GMP Compliance
Beijing, Beijing, China · On-site
Job Description R&D Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-qualit…
Skills: Audits Compliance, Compliance Program Development, Crisis Management, Ethical Compliance, Investigative Skills
Boston, Massachusetts, United States · On-site
$256k–$403k/yr
Job Description Our company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind …
Skills: Clinical Development, Clinical Trial Designs, Clinical Trial Planning, Clinical Trials Monitoring, Drug Development
Boston, Massachusetts, United States · Hybrid
$282k–$444k/yr
Job Description The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic…
Skills: Clinical Development, Clinical Research Management, Clinical Trial Development, Drug Development, Hematology
North Wales, Pennsylvania, United States · Hybrid
$142k–$224k/yr
Job Description Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwav…
Skills: Adaptability, Biopharmaceutical Industry, Digital Marketing, Market Access, Market Research
Upper Gwynedd Township, Pennsylvania, United States · On-site
$173k–$273k/yr
Job Description Director, Discovery Process Chemistry, West Point, PA Job Description Throughout the drug discovery lifecycle, sustained investment in innovative chemistry can inspire design and enable the synthesis of t…
Skills: Bioanalytical Analysis, Catalysis, Chemical Biology, Medicinal Chemistry, Mentoring Staff
Upper Gwynedd Township, Pennsylvania, United States · On-site
$173k–$273k/yr
Job Description Join Our Company’s Manufacturing Division as a Director/ Principal Scientist, Biologics Drug Substance Commercialization (BDSC). This senior leadership role is responsible for driving late-stage and comme…
Skills: Antibody Therapeutics, Biologics, Cell Cultures, Clinical Manufacturing, Commercialization
Rahway, New Jersey, United States · Hybrid
$173k–$273k/yr
Job Description At our company, we aspire to be the premier research-intensive biopharmaceutical organization, advancing innovative health solutions for people and animals worldwide. We leverage leading-edge science to t…
Skills: Business Analysis, Commercial Business Development, Data Science, Demand Management, Digital Products
Chiyoda, Japan · Hybrid
Job Description Specialty Care New Product Lead (Director) Our company is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that improve and save li…
Skills: Business Analysis, Brand Management, Project Management, Sales Forecasting, Strategic Thinking
Rahway, New Jersey, United States · On-site
$142k–$224k/yr
Job Description Job Description Are you enthusiastic and driven to create and lead execution of combination product testing strategies for innovative combination products? Join our company’s Device Development & Technolo…
Skills: Combination Products, Design Verification Testing, Design Controls, Project Leadership, Method Validation
Upper Gwynedd Township, Pennsylvania, United States · On-site
$173k–$273k/yr
Job Description Principal Scientist, Biologics, Sterile Drug Product Commercialization As part of Our Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides the technical process lead…
Skills: Drug Product Development, Drug Product Manufacturing, Process Characterization, Process Optimization, Manufacturing Scale-Up
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Acts as the primary site contact and manager throughout all phases of clinical research studies to ensure site readiness and compliance. Performs remote and on-site monitoring activities to protect subject safety and ensure data accuracy in accordance with ICH-GCP and protocol guidelines.
Requires a degree in a scientific or healthcare discipline with experience ranging from 6 months to 3 years depending on the degree level. Candidates must be fluent in English and the local language with a strong understanding of GCP/ICH guidelines and clinical research laws.
Job Description
With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager
throughout all phases of a clinical research study, taking responsibility of allocated sites.
phases of the trial.
Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated
documents.
Site Ready.
o Data generated atsite are complete, accurate and unbiased
o Subjects’ right, safety and well-being are protected
visits, close-out visits and records clear, comprehensive and accurate visit & non-visit
contact reports appropriately in a timely manner.
maintenance and study close-out.
recruitment, retention, protocol deviations, regulatory documentation, site
audits/inspections and overall site performance.
escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA
Manager, CRM, TA Head and CRD as needed.
pharmacovigilance, legal and regional operations, HQ functional areas and externally with
vendors and IRB/IECs and Regulatory Authorities in support of assigned sites
systems as appropriate and per timelines.
communication skills, including the ability to understand technical information.
Developing ability to present technical information with support.
trials, current GCP/ICH & country clinical research law & guidelines.
within these guidelines.
and patient recruitment
tablet and mobile devices) and ability to adapt to new IT applications on various
devices.
action.
with at least 3 years of relevant experience in the healthcare field.
Or
months of relevant experience in the healthcare field.
or
2 years of relevant experience in the healthcare field
Current Employees apply HERE
Current Contingent Workers apply HERE
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Travel Requirements:
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
