FAQs
What kind of documents will I be responsible for writing or editing?
You will be responsible for writing and/or editing high-quality safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Disease and Product ID Cards, product alerts, and trial transparency documents.
What qualifications are required for this position?
An advanced degree in life sciences, pharmacy, or a similar discipline (PhD, Master's, or Bachelor's in science, D Pharma, PharmD) or a medical degree (MBBS, BDS, BAMS, BHMS, MD) is required.
How much experience is needed for this role?
More than 2 years of experience in regulatory writing for the pharmaceuticals or healthcare industry is essential.
What soft skills are necessary for success in this role?
Essential soft skills include stakeholder management, vendor management, strong communication skills, and the ability to work independently and collaboratively within a team environment.
What technical skills should I possess?
Required technical skills include excellent technical (medical) editing and writing skills, data retrieval and interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, and proficiency in computer applications.
Will I collaborate with other teams?
Yes, you will collaborate effectively with scientific communication teams, medical regulatory writing teams, pharmacovigilance teams, regulatory teams, and corporate affairs teams.
Is knowledge of English required for this position?
Yes, excellent knowledge of the English language (to read, write, and speak) is required.
What are the primary responsibilities of this position?
The primary responsibilities include writing and editing various medical regulatory documents, maintaining relationships with stakeholders, delivering high-quality documents on time, and ensuring compliance with internal and external guidelines.
How should I handle stakeholder interactions?
You should maintain effective relationships with the end stakeholders within the allocated Global business unit and product and interact effectively with stakeholders in medical and pharmacovigilance departments.
Will I receive training or mentoring in this role?
Yes, you will initially participate with support in the planning of analysis and data presentation under the guidance of a mentoring medical writer.
What is the expected reporting format for deliverables?
You will provide deliverables such as PBRER, ACO, Product and Disease ID Cards, and other documents as per agreed timelines and quality standards.