FAQs
What are the primary responsibilities of the Expert Medical Regulatory Writer?
The primary responsibilities include writing and editing high-quality clinical and safety documents for regulatory submission, leading complex submissions, collaborating with various teams, mentoring other medical writers, and ensuring compliance with internal and external guidelines.
How much experience is required for this position?
A minimum of 8 years of experience in regulatory writing for the pharmaceuticals or healthcare industry is required.
What type of documents will I be responsible for writing?
You will be responsible for writing complex Clinical Study Reports (CSR), CTD submission documents, Periodic Benefit-Risk Evaluation Reports (PBRER), Risk Management Plans (RMP), and other regulatory documents.
What educational background is preferred for this role?
An advanced degree in life sciences, pharmacy, or a similar discipline (such as a PhD, Masters, or Bachelor's in Science, D Pharma, Pharm D) or a medical degree (MBBS, BDS, BAMS, BHMS, MD) is preferred.
What specific skills are important for this job?
Important skills include stakeholder management, communication skills, and the ability to work independently and as part of a team. Technical skills related to therapeutic area knowledge and project management are also important.
Is mentorship or training part of the role?
Yes, the position involves mentoring and training junior medical regulatory writers to help develop their skills and expertise.
What is the collaboration structure for this position?
The role involves collaboration with Scientific communication teams, medical regulatory writing teams, Pharmacovigilance teams, and other clinical and safety teams.
Are there opportunities to work across different therapeutic areas?
Yes, the position requires agility and knowledge to work across various therapeutic areas.
Is fluency in any specific language required?
Yes, excellent knowledge of the English language (reading, writing, and speaking) is required.