เงื่อนไขการค้นหา

ประสบการณ์:

4 ปีขึ้นไป

ทักษะ:

Research, Compliance, Finance, English

ประเภทงาน:

งานประจำ

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• o Data generated at site are complete, accurate and unbiased.
• o Subjects right, safety and well-being are protected.Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
• CORE Competency Expectations:Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
• Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
• Required:Min. 4 years of direct site management (monitoring) experience in a bio/pharma/CRO.
• B.A./B.S. with strong emphasis in science and/or biology.
• Current Employees apply HERE.
• Current Contingent Workers apply HERE.
• Search Firm Representatives Please Read Carefully
• 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.
• Regular
• Not Applicable
• 02/28/2025A 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.
• Requisition ID:R332366.

ทักษะ:

Product Development, Compliance, English

ประเภทงาน:

งานประจำ

• Develop and implement regulatory strategies aligned with business goals and current trends.
• Identify regulatory requirements and potential challenges early in product development.
• Submission Management.
• Prepare, review, and submit regulatory documentation to Thai FDA for product registration and variations.
• Manage submission timelines and deliverables to ensure timely approvals.
• Compliance Oversight.
• Ensure products meet local, national, and international regulations throughout their lifecycle.
• Monitor and communicate changes in regulatory requirements to relevant teams.
• Regulatory Agency Interactions.
• Act as the primary contact for regulatory agencies, ensuring clear communication and effective problem-solving.
• Lead presentations during agency meetings to address inquiries and progress submissions.
• University Degree in Pharmaceutical Science. Master Degree will be a plus.
• Proven track record in handling product registration with Thai FDA.
• Minimum 3-5 years experience in managing product registration processes in Pharmaceutical in a multinational environment.
• At least 3 years experience in Pharmaceutical Registration field is a plus.
• Have a strong connection with Thai FDA is a plus.
• Good understanding of regulatory compliance and strong knowledge of local regulatory requirements for product registration.
• Strong planning, organizing and analytical skills.
• Outstanding problem solving and decision making skills.
• A professional attitude and high ethical standards.
• Good networking skills and result-oriented.
• Excellent communication skills in both Thai and English (verbal and written).
• Good computer skills.

ทักษะ:

Negotiation, English

ประเภทงาน:

งานประจำ

• Ensure the product, label, and advertising complied with the regulation, company guidelines, and policies.
• Risk prevention on formulation and label screening.
• Support all necessary regulatory information to related function.
• Maintaining and secure the regulatory database.
• Keep update new regulation.
• Build up a relationship to run the business smoothly with the Food and Drug Administration (FDA), Thai Industrial Standards Institute (TISI), Ministry of Commerce, Office of Consumer Protection Board, Thai Customs, and Others.
• Support all RA projects.
• Bachelor degree up in Food Science, Pharmacy or related field.
• Minimum 10 years working experience in regulatory affairs area especially in food product.
• Strong interpersonal, negotiation, communication and presentation skills.
• Good command of written & spoken English including computer literacy.
• High ability to learn with good attitude.
• Ability to effectively manage projects and good human relation.
• CP AXTRA | Lotus's
• CP AXTRA Public Company Limited.
• Nawamin Office: Buengkum, Bangkok 10230, Thailand.
• By applying for this position, you consent to the collection, use and disclosure of your personal data to us, our recruitment firms and all relevant third parties for the purpose of processing your application for this job position (or any other suitable positions within Lotus's and its subsidiaries, if any). You understand and acknowledge that your personal data will be processed in accordance with the law and our policy. .

ทักษะ:

Compliance, Legal, English

ประเภทงาน:

งานประจำ

• Monitor and implement the Company s governing documents, such as the Code of Conduct and other relevant policies, ensuring compliance with internal and external standards.
• Oversee and report on compliance activities within the Company, ensuring timely identification and resolution of any compliance risks.
• Communicate the Company s Code of Conduct and relevant policies to internal and external stakeholders, ensuring clear understanding of compliance responsibilities.
• Conduct training programs for all employees to ensure comprehensive understanding and adherence to compliance policies.
• Ensure adherence to regulations set by the SEC, SET, and other relevant governmental authorities.
• Oversee and review business processes to ensure compliance with governing documents, laws, and regulations.
• Advise on changes in compliance risk, providing insights on legal and regulatory changes, business risks, and mitigation strategies.
• Maintain and update the Code of Conduct and other relevant policies annually, including obtaining necessary approvals.
• Establish and maintain effective compliance record-keeping systems, preparing reports for management and external regulators as required.
• Bachelor s Degree in Law.
• A minimum of 5 years of experience with background in Law, Compliance, in retail business is a plus.
• In-depth knowledge of data protection law.
• Ability to plan, organize and prioritize task and projects.
• Good analytic skill and high commercial sense.
• Ability to work under pressure.
• Ability to resolve problem quickly.
• Excellent interpersonal & communication skill.
• Good English skills.
• Interested applicant may send your updated resume and recent photo via APPLY NOW and only qualified and shortlisted candidates will be contacted.
• Siam Piwat Company Limited
• 6th Floor Siam Paragon
• 989 Rama 1 Road, Pathumwan
• Bangkok 10330, Thailand
• www.siampiwat.com.

ทักษะ:

Product Development

ประเภทงาน:

งานประจำ

• Develop and execute regulatory strategies for medical device products, ensuring alignment with business objectives and up-to-date regulatory trends.
• Identify regulatory requirements and potential challenges early in the product development process.
• Submission Management.
• Prepare, review, and submit high-quality regulatory documentation for submission to Thai FDA for new product registration and variation.
• Manage timelines and deliverables for regulatory submissions to ensure timely approvals.
• Compliance Oversight.
• Ensure that products comply with all local, national, and international regulations, guidelines, and standards throughout their lifecycle.
• Monitor and interpret changes in regulatory requirements and communicate their impacts to cross-functional teams.
• Regulatory Agency Interactions.
• Serve as the primary point of contact for regulatory agencies, facilitating clear communication and effective problem-solving during interactions.
• Prepare and lead presentations during agency meetings to address inquiries and advance regulatory submissions.
• Bachelor s degree in Life Sciences, Engineering, or a related field.
• Minimum of 2 years of experience in regulatory affairs within the medical device industry.
• Comprehensive understanding of global regulatory requirements in Thailand.
• Proven track record of successful submissions and approvals for medical device.

ประสบการณ์:

7 ปีขึ้นไป

ทักษะ:

Nutrition, Product Development, Project Management

ประเภทงาน:

งานประจำ

• Mainly responsible for process development and product qualifications for infant, children and adult nutrition products for Asean and South Asia manufactured at third party subcontractors and MJN plants.
• Responsible for process development, commissioning and qualification for equipment in R&D technology centers.
• Make use of internal and external technical resources, perform technical assessments, experiments and testing, implement process development from product concept, formu ...
• Prepare technical documents necessary for each phase of the development from initiation stage, process validation to post launch and handover for product maintenance after launch.
• Interactions with cross-functions include market, regional and global R&D functions of Regulatory Affairs, Product Development, Process Engineering, R&D Operations, Analytical Science, Sensory Teams, Packaging Managers, R&D Technical Centers Teams, Project Management, Quality Managers, Quality Laboratory Staff, Compliance Managers, Procurement, Finance, Supply Chain, Marketing, Suppliers, Technology Providers, Research Institutions, third-party service providers, R&D technicians/consultants/temp staff (leased).
• The experience we're looking for.
• B.S. in Engineering, such as and not limited to, Chemical Engineering, Food Engineering, Biochemical Engineering, Mechanical Engineering, or any other Engineering related course. Master s Degree is an advantage.
• At least 7 years of experience in food/pharmaceutical/beverage manufacturing industry in R&D, QA or production functions with at least 5 years of those spent working in aspects of manufacturing process, process engineering, or process development.
• At least 3 years of experience as Process Engineer operating key process technologies related to food and beverage manufacturing such as dry powder blending, powder conveying, liquid processing and spray drying; experience in any one of aseptic process and packaging, membrane filtration and separation technologies, enzymatic and hydrolysis processes is an advantage.
• Demonstrate working knowledge on key unit operations and process technologies used in food and beverage industry and its relationship to overall product functionality and quality.
• Demonstrate application of mass balance, heat transfer, process flow, process specification of one or more technology platforms.
• Applies statistical design concepts towards the execution of process studies.
• Demonstrate skill creating process flow diagrams and related engineering diagrams.
• Demonstrates understanding of technical and industry practices, manufacturing industries, relevant unit operations necessary for successful qualification of new and improved processes.
• The skills for success.
• Business Strategy, Task Execution Under Pressure, Makes strategic Business Decisions, Business Accumen, Commercial Awareness, Objective Setting, Accountability, Adaptability, Consumer Insight, Creative Direction, Consumer Needs, R&D, Product Lifecycle Management, Change Leadership, Intellectual Property, Business Partnership, Collaboration and partnership building, Collaborator, Relationship Management, Adapt to changes in technological development plans, Product vision and strategy development, Ability to challenge the status quo and propose improvement, Innovation Processes, Predictive Analytics, Digital transformation for R&D, Quality and Manufacturing.
• What we offer.
• With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
• We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
• Equality.
• We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
• All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.