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- Mature and seasoned team to work with
- Cutting edge pipeline and product development
About Our Client
Our client comprises a dynamic team of researchers, scientists, and experts who share an unwavering passion for revolutionizing lives through groundbreaking discoveries. With a profound commitment to excellence and a steadfast dedication to advancing biotechnological solutions, they tackle some of the most pressing global health challenges of our era.
Through meticulous research, state-of-the-art technology, and fruitful collaborations with key stakeholders, our client pioneers a brighter and healthier future. Their tireless efforts continuously push the boundaries of what's achievable in biotechnology, all while upholding the highest ethical standards and prioritizing patient well-being.
Job Description
Protocol Development: Take the lead in designing and fully writing study protocols, ensuring they meet the highest scientific standards and regulatory requirements.
Essential Document Preparation: Develop and create essential study documents such as Investigator Brochures (IB) and Informed Consent Forms (ICF) to ensure compliance with industry regulations.
IND Submission: Prepare and compile documents for Investigational New Drug (IND) submissions for regulatory agencies such as the US FDA, NMPA, and TFDA.
Medical Monitoring: Act as the medical monitor, actively engaging in resolving study-related medical issues to ensure the safety and well-being of participants.
Collaboration: Serve as the primary point of contact for discussing study medical matters with Contract Research Organizations (CROs) and Principal Investigators (PIs).
Key Opinion Leader Engagement: Identify, establish, and leverage scientific relationships with key opinion leaders in the field to advance our research endeavors.
Consultant Meetings: Organize and host consultant meetings, facilitating discussions, and delivering detailed meeting minutes.
Additional Tasks: Undertake any other tasks assigned by the line manager that contribute to the successful execution of clinical drug development.
The Successful Applicant
- Minimum of 2 years of experience as a medical writer in a CRO, pharmaceutical, or biotechnology setting.
- In-depth understanding of clinical development and the ability to present clinical data accurately and clearly.
- Working knowledge of ICH and other regulatory guidelines is essential.
- Excellent English-speaking skills.
- Strong verbal, written, and interpersonal communication skills, along with proficiency in Microsoft Word.
- Exceptional regulatory writing skills with a keen attention to detail.
What's on Offer
To join our client on this extraordinary journey as they unlock the true potential of science, making a meaningful impact on people's lives worldwide. Together, we can forge a better tomorrow through the transformative power of biotechnology.
