Customs Specialist performing Customs business activities focusing on entry and admissibility of merchandise with U.S. Customs. Responsible for compliance, document verification, and clearance monitoring.
About the role
- 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)
Benefits
- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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