Hybrid Senior Director, Medical Writing

Posted 17 minutes ago

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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

Senior Director, Medical Writing

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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