Trial Activation Approval Specialist III

2 weeks ago

Metro Manila, Philippines Thermo Fisher Scientific Full time

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.Summarized Purpose:

Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.Key responsibilities:

Prepares, review and coordinates submissions (MoH, EC, applications if, e.g. gene therapy approvals, safety dossiers, import license) in alignment with global submission strategy.Provides strategy advice (MoH &/or EC) to clients.Develops and implements local submission strategy. Provides expertise and coordination oversight for projects in collaboration with relevant internal departments.Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a timely manner.Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.Acts as a key-contact at country level for all submission-related activities.Participates as the need arises in Submission Team Meetings, Review Meetings and Project Team meetings.Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.Achieves PPD’s target cycle times for site activations.Prepares the regulatory compliance review packages, as applicable.Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.Develops country specific Patient Information Sheet/Informed Consent form documents.May assist with grant budgets(s) and payment schedules negotiations with sites.Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.Oversees country study files and ensures that they meet PPD WPD’s or client SOP’s.Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.Advises/mentos other SIA individuals assigned to support projects of responsibility, as appropriateProactively identifies issues or anomalies in the regulatory process of a study, resolves or escalates as appropriate.Keys to Success

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).Knowledge, Skills and Abilities:Effective oral and written communication skillsExcellent interpersonal skillsStrong attention to detail and quality of documentationGood negotiation skillsGood digital literacy and the ability to learn appropriate softwareGood English language and grammar skillsGood judgment and decision-making skillsBasic medical/therapeutic area and medical terminology knowledgeAbility to work in a team environment or independently, with minimal direction, as requiredAbility to mentor fellow SIA team members in a positive and effective mannerExcellent team player with teambuilding skillsBasic organizational and planning skillsExcellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations

  • Trial Activation Approval Specialist III

    1 week ago

    Manila, National Capital Region, Philippines Thermo Fisher Scientific Full time

    Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step...

  • Site Activation Coordinator

    2 weeks ago

    Metro Manila, Philippines Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWe are currently seeking a Site Activation Coordinator to join our Project Delivery team in various location across the region. We are welcoming applications from candidates in the Philippines.The STM Site Activation Coordinator will provide administrative support to our Start-Up...

  • Clinical Trial Coordinator

    2 weeks ago

    Metro Manila, Philippines Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Site Activation Coordinator

    1 week ago

    Manila, National Capital Region, Philippines Thermo Fisher Scientific Full time

    Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionWe are currently seeking a Site Activation Coordinator to join our Project Delivery team in various location across the region. We are welcoming applications from candidates in the Philippines.The STM Site Activation Coordinator will provide administrative support to our Start-Up...

  • Clinical Trial Coordinator

    1 week ago

    Manila, National Capital Region, Philippines Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Activation Lead

    2 weeks ago

    Manila, National Capital Region, Philippines JTI Full time

    Search by keyword and location and click "create alert" to receive your job alerts by email: Select how often (in days) to receive an alert: North GMA, PH, 00000 North GMA, PH, 00000 We are JTI, Japan Tobacco International, and we are present in 130 countries. We have spent years innovating, creating new and better products for the consumers to choose...

  • E-Learning Development Specialist III

    2 weeks ago

    Manila, National Capital Region, Philippines LexisNexis Risk Solutions Full time

    E-Learning Development Specialist III page is loaded E-Learning Development Specialist III Apply locations Manila Philippines time type Full time posted on Posted Yesterday job requisition id R79054 ResponsibilitiesAssisting customers implementing e-products into their curriculum. You will do this through a variety of means including sharing best practices,...

  • Marketing Services Specialist

    2 weeks ago

    Metro Manila, Philippines Marigold Manufacturing Corporation Full time

    Be another key ingredient! Join the team that manufactures the most popular Filipino brand in mixes, sauces, condiments, and more, Mama Sita's!Minimum Qualifications/ Experiences:Graduate of BS Hotel and Restaurant Management, Culinary Arts or Food Service, or any Business related courseWith at least 1-2 years experience in Kitchen Operations, Food Service,...

  • Corporate & Investment Banking - Transactions Specialist III

    5 days ago

    Metro Manila, Philippines JPMorgan Chase Full time

    As a Transactions specialist III, you will be processing USD payments, ensuring accuracy, and maintaining compliance with internal and external regulations. This role requires strong analytical skills, attention to detail, and the ability to work collaboratively in a fast-paced environment. This unit is the central operations contact for USD payments...

  • Junior R&D Product Development Specialist

    2 weeks ago

    Metro Manila, Philippines Marigold Manufacturing Corporation Full time

    Be another key ingredient! Join the team that manufactures the most popular Filipino brand in mixes, sauces, condiments, and more, Mama Sita's!The Jr. R&D Product Development Specialist is responsible for performing product development from product concept until product commercialization. It includes the development of the new product, product reformulation,...

  • Brand Marketing Specialist

    1 week ago

    Metro Manila, Philippines AsiaPeopleSearch Inc. Full time

    About the jobJob Summary: The Marketing Communications Specialist plays a key part in the development and execution of the Brand Plan and Marketing Communications Plan for the Company. The role is expected to collaborate closely with regional and local agency partners in creating and executing marketing campaigns.  Key responsibilities include providing...

  • Audit Specialist

    1 week ago

    Metro Manila, Philippines Vision Express Philippines Full time

    The Audit Specialist for Operations will assist the Compliance Manager in the evaluation of the departments or employees’ compliance with the standard and approved operating policies and procedures of the Company, including assessment of internal controls. By the end of every audit engagement, the Audit Specialist will provide recommendations to improve...

  • Senior Specialist

    2 weeks ago

    Manila, National Capital Region, Philippines ING Hubs B.V. Philippine Branch Full time

    Description: Non-Financial Risk Specialist III assigned to NFR Services Team is part of the team that supports Non-Financial Risk (NFR) Center of Excellence (CoE) in accordance with duly approved Workplace Instructions (WPIs) and interact with relevant stakeholders in the locations within scope of service, such as the following:Services expected to be...

  • R&D Process Development Specialist

    2 weeks ago

    Metro Manila, Philippines Marigold Manufacturing Corporation Full time

    Be another key ingredient! Join the team that manufactures the most popular Filipino brand in mixes, sauces, condiments, and more, Mama Sita's!The Junior R&D Process Development Specialist's main function is to perform studies and trials of any recurring concern and challenges of any existing product characteristics if a particular process and initiate and...

  • Marketing Services Specialist

    2 weeks ago

    Manila, National Capital Region, Philippines Marigold Manufacturing Corporation Full time

    Be another key ingredient Join the team that manufactures the most popular Filipino brand in mixes, sauces, condiments, and more, Mama Sita'sMinimum Qualifications/ Experiences:Graduate of BS Hotel and Restaurant Management, Culinary Arts or Food Service, or any Business related courseWith at least 1-2 years experience in Kitchen Operations, Food Service,...

  • Marketing Services Specialist

    2 weeks ago

    Manila, National Capital Region, Philippines Marigold Manufacturing Corporation Full time

    Be another key ingredient Join the team that manufactures the most popular Filipino brand in mixes, sauces, condiments, and more, Mama Sita'sMinimum Qualifications/ Experiences:Graduate of BS Hotel and Restaurant Management, Culinary Arts or Food Service, or any Business related courseWith at least 1-2 years experience in Kitchen Operations, Food Service,...

  • Sales Executives

    1 week ago

    Metro Manila, Philippines Nipro Medical Philippines Corporation Full time

               Summary:      Renal Care Specialist reports directly to the Regional Sales Manager/District Sales Manager.     Job Objective:    The Sales Executive / Renal Sales Specialist is tasked to represent the company in an assigned area, territory or institution, delivering both sales and marketing functions and ensuring that appropriate...

  • Documentation Specialist

    1 week ago

    Metro Manila, Philippines Power Integrations Netherlands B.V. - Philippine Branch Full time

    Job Summary   A documentation specialist is responsible for creating documents and maintaining document records, shepherding documentation through the internal approval process as well as organizing translation and dissemination of completed documents to the appropriate locations. Your primary job is to manage document drafts and component parts, use them...

  • Project Development Manager

    3 weeks ago

    Metro Manila, Philippines NLEX Corporation Full time

    Job Summary:Lead the project development efforts and activities of the company in developing new toll road concession projects as well as the enhancements, and expansion of project roads within the existing concessions to strengthen the core business and ensure long-term revenue growth. He/She may also be tapped by other Business Units within the MPTC Group...

  • Food Technologist

    1 day ago

    Metro Manila, Philippines CUCINA PORTA ROSSA CORPORATION Full time

    Job QualificationsBachelor's Degree in Food Technology1 - 5 years related work experience preferably as QA/QC/R&D/Production SpecialistStrong analytical, critical thinking, and problem-solving skillsDetail-oriented and has basic cooking skillsAbility to plan, organize and prioritize work, and multitaskAbility to communicate effectivelyAbility to work under...