Bring medical expertise to clinical studies, from protocol discussions and document reviews to safety assessments and regulatory submissions. You’ll work with research, pharmacovigilance and regulatory colleagues, and help the research team keep its disease and product knowledge up to date.
What you’ll do
- Carry out planned clinical medical research activities. Coordinate expert discussions, protocol revisions, data analysis, study summaries and publication work.
- Coordinate the review and revision of study protocols, investigator brochures, case report forms and related study documents.
- Coordinate the review and revision of clinical study reports, clinical overviews and other clinical sections of submission documents. Work with regulatory colleagues to draft the medical documents required for registration.
- Medically assess adverse reactions during clinical studies, ensuring the work meets Good Clinical Practice (GCP) and study-protocol requirements.
- Organize regular and ad hoc clinical-study audits with medical-department colleagues, promptly identifying and resolving medical issues that arise in trials.
- Work with pharmacovigilance (PV) colleagues to assess and classify adverse drug reactions. Help manage the receipt, processing, reporting and follow-up of individual case safety reports from clinical trials.
- Ensure safety reports are complete and accurate, and submitted to domestic and international regulators within the required regulatory timelines.
- Follow medical developments in the relevant disease areas and guide updates to the team’s product medical knowledge base and related training. Support clinical research colleagues with guidance and training.
What you’ll bring
- A master’s degree or above and a background in clinical medicine.
- At least five years of clinical and research experience in a relevant field.
- Thorough knowledge of the relevant diseases and products.
- A strong command of GCP regulations and requirements.
- Fluent spoken and written English, with strong listening and reading skills.
- Good communication skills and the ability to work effectively with colleagues.
Preferred background
- A background in endocrinology.
Original role description
Responsibilities
1. Implement plans for clinical medical research activities.
2. Organise expert discussions, protocol review and revision, data analysis, study summaries and publication.
3. Coordinate review and revision of study protocols, investigator brochures, case report forms and related clinical-research materials.
4. Coordinate review and revision of the clinical sections of regulatory submissions, including clinical study reports and clinical overviews.
5. Guide clinical research team members and provide training and support.
6. Perform medical assessment of adverse reactions arising during clinical studies and ensure compliance with GCP and study protocols.
7. Organise periodic or ad hoc clinical-research audits by medical-department staff to identify and resolve medical issues promptly.
8. Work with pharmacovigilance (PV) colleagues to assess and classify adverse reactions. Support receipt, processing, reporting and follow-up of individual case safety reports from clinical trials, ensuring complete, accurate information and submission to domestic and international regulators within required timelines.
9. Work with regulatory colleagues on medical documents required for registration. Track developments in relevant disease areas and guide updates to the product medical-knowledge database and associated training.
10. Complete other tasks assigned or delegated by the supervisor.
Requirements
1. Master’s degree or above.
2. Clinical medicine background; endocrinology experience preferred.
3. Good spoken and written English, including listening and reading skills.
4. At least five years of clinical and research experience in a relevant field.
5. Strong knowledge of relevant diseases and products, and a thorough understanding of GCP regulations and requirements.
6. Good communication and collaboration skills.