Amandeep Singh

Associate Medical Writer @Parexel

Chandigarh, IN

Prepare and review safety narratives and other regulatory requirements,· Serves as peer reviewer on internal review team,· Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format,· Ensure documents comply with international regulatory guidelines,· Working knowledge of drug development process and regulatory guidelines,· Interacts with department head and staff members in data management, regulatory affairs, and medical affairs as necessary to produce writing deliverables,· Coordinate and author patient alert cards, direct healthcare practitioner communications, healthcare professional guides, and dosing guides,· Maintain high-quality in given timeframe,· Performs on-line clinical literature searches, as applicable,· Ensure narratives comply with sponsor-specific requirements,· Strong understanding of regulatory requirements for clinical safety reporting,· Experienced in various databases (Veeva vault, Argus, etc.),· Mentor new joiners in process workflow,· Participate in internal and external audits as a subject matter expert

Sikkim Manipal University - Distance Education

Master's degree

Punjabi University

Msc biotechnology

Chitkara University

Bachelor of Pharmacy - BPharm