Description
We are seeking a PMS Specialist to manage all aspects of post-marketing regulatory commitment studies and related non-interventional or real-world evidence research projects.
The successful candidate will lead regulatory commitment studies, ensuring full compliance with regulatory requirements throughout the study lifecycle, including planning, data collection, analysis, and clinical study report development.
Key responsibilities include:
- Leading regulatory commitment studies and ensuring compliance with regulatory requirements
- Developing, reviewing, and maintaining key study documents
- Overseeing end-to-end study execution and budget management
- Acting as business owner for CROs and external vendors
- Leading strategic interactions and communications with regulatory authorities
- Collaborating with cross-functional teams and external stakeholders
- Developing and executing publication strategies
- Authoring and co-authoring scientific publications and presentations
Requirements:
- MS in science, pharmacy, epidemiology, biostatistics, nursing, medical science, or a related life-science discipline
- 2+ years of experience in post-marketing study, non-interventional studies, real-world evidence, epidemiology, or regulatory commitment engagement within the pharmaceutical industry
- Advanced medical writing skills
- Experience in scientific publication activities
We offer a range of benefits, including opportunities for growth and development, a culture of agility and flexibility, and a commitment to creating an inclusive workplace.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.