Director Medical Writing Asset Lead

Overview

Director Medical Writing Asset Lead responsible for medical writing and submissions strategy for one or more drug development assets.

What you'll do

• Provide clinical document strategy contributions across the drug development life cycle for assigned assets.
• Design and deliver fit-for-purpose clinical documents for global regulatory submissions.
• Lead matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors.
• Independently plan and deliver large submissions, recommending methods to achieve accelerated timelines.
• Collaborate with Global Regulatory Affairs to align global submissions with regulatory requirements.
• Act as lead author and organize content/arguments for complex clinical submission documents and responses to regulatory questions.

What you'll need

• PhD, PharmD, MPH, MSc, or other post-graduate degree.
• Substantial experience in clinical regulatory writing and regulatory submissions in the pharmaceutical industry.
• Proven track record of writing the clinical documents in scope.
• Strong project management and planning experience.
• Demonstrated matrix leadership and communication to deliver results.

Details

• Work mode: hybrid, with on-site 2/3 days per week as agreed with manager.
• Location (ATS): Bengaluru Luxor North Tower.