Total 2 research officer job vacancies in Education / Training category in D17 Loyang, Changi

As a Sr. Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a well-known global pharmaceutical company with a strong portfolio in cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation medicines.

You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.

What you will be doing:

• Perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
• Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e., operating manuals, monitoring guidelines, etc.);
• Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the Project Manager.
• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department.
• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports.

You are:

• Degree in Pharmacy or any related course.
• 4+ years prior monitoring experience with global trials.
• Experience with clinical trial set up and contract negotiation preferred, but not essential.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, good knowledge of local regulations.
• Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Job summary

1) Responsible for the development of new product formulations (wet towels, liquid products and any new products that company may develop), including improvement of existing formulations.

2) Ensure that all wet towels/products comply to the relevant statutory board standards, including the submission of relevant documents.

3) To work as part of a R&D/QA/QC team.

Area of responsibilities

1) Research and develops new product formulations (wet towel, liquid products and any new products that company may develop) for local market and overseas clients including improvement of existing formulations.

2) Check and reviews product data sheet (PDS), certificate of analysis (COA), safety data sheet (SDS) and provides technical support to Sales & Marketing.

3) Conducts product validation and stability testing especially for new formulations or any major changes in existing formulations and troubleshoots quality and microbial issues.

4) Research and reviews product testing & analysis appropriate for product claims and coordinate with qualified local and overseas laboratories for final product testing.

5) Provide analytical service in the assessment and evaluation of raw materials, samples and products submitted by customers or affiliates.

6) Formulates, updates and revises, when necessary, the quality assurance systems/quality control procedures of the Company.

7) Assists, if needed, in the physico-chemical evaluation and microbial analysis of raw materials, packaging materials and finished goods.

8) Assist to investigates internal and external (customer) complaints and review the Non-Conformance Report (NCR) before submission.

9) Assist QA in Supplier’s audit in accordance with In-house Standards & Good Manufacturing Practices (GMP) standards.

10) Represents R&D Department and act as a committee member in industry certifications (i.e. ISO 9001, ISO 22301, ISO 13485, GMP, EU MDR).

11) Prepares technical documents and apply for product notifications and registrations to government agencies such as HSA, NEA etc.

12) Assist overseas manufacturing facilities (China, Indonesia) on formulations and technical documentations if needed.

13) Supervise and manage R&D/QA/QC team (training, leave approval, others).

14) Any other area of responsibilities that the company deems necessary.

Requirements

1. Degree in Chemistry/Pharmaceutical Science or any related courses.

2. Must have at least 3 years experience in Manufacturing/Product Development/Regulations.

3. Knowledge in Medical Industry will be an advantage.