Senior Director overseeing medical writing for clinical developments at CSL Behring. Responsible for quality delivery and leading a team of medical writers.
Responsibilities
Responsible for the quality and delivery of high-quality clinical development documents across the portfolio
Overseeing the recruiting, staffing and training development of the medical writing specialists in the group
Ensuring delivery of high-quality clinical development content including: Provision of medical writing services to support the clinical development, clinical safety and regulatory requirements of our clinical programs
Efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables
Development, oversight and delivery of Quality Controls to assure high-quality documents
Support collaboration with CSL’s CRO partners
Requirements
Graduate level degree (M.Sc, PhD, MD etc)
10 yrs+ of Pharma experience in clinical development
Experience across all phases of development, FIH, POC, late-stage development and life cycle management
Strong track record of successful medical writing leadership
Experience across a wide range of regulatory document writing e.g. protocols, CSRs, CTDs, Briefing Documents, etc
High level of self-awareness and the awareness of personal impact
Enhanced organizational awareness and the ability to interact and influence from the team level to senior management
Succinct, concise and clear communication style
Extensive experience of leading teams and/or line managing a group(s)
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