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Full-time
bachelor degree
Posted 37d ago
Apply by Jul 31
~40 hrs/week
Responsibilities
The role involves evaluating clinical data submitted for therapeutic product registration and providing technical advice on data requirements. Additionally, the specialist will represent HSA in external engagements and contribute to the development of regulatory guidelines.
Requirements
Candidates should have a background in Medicine, Pharmacy, or a related discipline with at least 7-10 years of relevant experience in clinical pharmacy or regulatory work. A strong understanding of pharmaceutical legislation and excellent communication skills are also required.
Full job description
[What the role is]
Clinical evaluation of therapeutic product registration submissions
[What you will be working on]
Evaluate clinical data submitted by pharmaceutical companies and provide technical advice on data requirements for therapeutic product registration applications.
Develop scientific opinions and position papers on evolving regulatory approach and technical requirements.
Represent HSA at external engagements, including meeting with sponsors, technical and advisory committees.
Foster partnership with international regulatory authorities through collaborative review and information sharing activities.
Serve as HSA's technical expert and front scientific discussions for workshare projects with international regulators.
Represent HSA at international regulatory forums, contributing to development of regulatory guidelines and standards.
[What we are looking for]
A background in Medicine, Pharmacy or related discipline with relevant experience in immunology or oncology.
RELEVANT EXPERIENCE
Minimum 7 - 10 years' experience in clinical pharmacy, medical practice, or clinical-related regulatory work.
Professional background in clinical practice or research, with knowledge of clinical practice guidelines.
Good understanding of pharmaceutical legislation and regulatory frameworks, with the ability to interpret and apply complex scientific and clinical information to inform regulatory and policy decisions.
Experience in supporting policy development initiatives, process improvements and contributing to policy decisions.
RELEVANT SKILLS
Excellent written and verbal communication abilities with attention to detail and the capacity to convey scientific matters clearly to diverse audiences, including senior decision-makers.
Strong relationship-building skills with the ability to engage effectively with diverse stakeholders and foster productive collaborative partnerships across various sectors.
Ability to analyse and integrate different sources of information to develop solutions.
Ability to take responsibility for individual and team performance, monitor workflow progress and consistently deliver quality outcomes within demanding timeframes whilst maintaining high standards.
Highly motivated with strong desire to protect public health and safety.
The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance.
Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified.
Engineering Digital Government. Making Lives Better. #GovTechForPublicGood
Industry
IT Services and IT Consulting
Company size
1,001-5,000 employees
Founded
2016
Headquarters
Singapore
LinkedIn followers
247,176
The Government Technology Agency of Singapore (GovTech) is the lead agency driving Singapore's Smart Nation initiative and public sector digital transformation. We harness the power of technology to make lives better for citizens, businesses, international audiences and the public service sector.
Our mission: Engineering Digital Government, Making Lives Better.
Our goal is to create a government that is "Digital to the Core, and Serves with Heart". We achieve this by using technology to create services that are easy, seamless and secure for people to use, and placing the needs of citizens and businesses at the centre of everything we do.
As a digital government, our public officers are also able to continually upskill, adapt to new challenges and work more effectively across agencies as well as with citizens and businesses in Singapore.
Offices: 10 Pasir Panjang Mapletree Business City, Singapore, 117438, SG
Digital GovernmentGovernment Digital ServicesDigital TransformationDigital IdentityData Science & Artificial IntelligenceCyber SecuritySensors & IoTGeospatial TechnologyGovernment ICT InfrastructureApplication Development & Design
Engineering Digital Government. Making Lives Better. #GovTechForPublicGood
Industry
IT Services and IT Consulting
Company size
1,001-5,000 employees
Founded
2016
Headquarters
Singapore
LinkedIn followers
247,176
The Government Technology Agency of Singapore (GovTech) is the lead agency driving Singapore's Smart Nation initiative and public sector digital transformation. We harness the power of technology to make lives better for citizens, businesses, international audiences and the public service sector.
Our mission: Engineering Digital Government, Making Lives Better.
Our goal is to create a government that is "Digital to the Core, and Serves with Heart". We achieve this by using technology to create services that are easy, seamless and secure for people to use, and placing the needs of citizens and businesses at the centre of everything we do.
As a digital government, our public officers are also able to continually upskill, adapt to new challenges and work more effectively across agencies as well as with citizens and businesses in Singapore.
Offices: 10 Pasir Panjang Mapletree Business City, Singapore, 117438, SG
Digital GovernmentGovernment Digital ServicesDigital TransformationDigital IdentityData Science & Artificial IntelligenceCyber SecuritySensors & IoTGeospatial TechnologyGovernment ICT InfrastructureApplication Development & Design