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Director, Clinical Regulatory Writing
hace 3 meses
Typical Accountabilities
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices.
We support the Company's core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.
The Clinical Regulatory Writing Director provides expert communications leadership for the most complex and business-critical clinical activities by driving strategic content development in alignment with product strategy and communications excellence.
The Clinical Regulatory Writing Director is encouraged to:
- Lead large, complex teams delivering business needs of the highest priority, while delegating to and empowering colleagues to undertake tasks and assignments.
- Lead development of the clinical submission communication strategy (cSCS) for complex and/or business critical submissions.
- Review across clinical regulatory documents for internal consistency and alignment while ensuring relevant regulatory, technical and quality standards are achieved and relevant processes and best practice are applied.
- Lead clinicalregulatory authoring teams during the regulatory response period up through approval.
- Effectively influence stakeholders and colleagues at the highest levels within a project, eg, to establish the best communications practices.
- Represent Clinical Regulatory Writing on crossfunctional teams and advocate and train teams in authoring and review best practice.
- Develop innovative best practices and improvement initiatives to support the skill.
- Work independently and support the growth and development of the group by actively mentoring Clinical Regulatory Writing Associate Directors and Managers and serving as a role model for the function.
- Have a broad knowledge of clinical development and the deliverables in scope for the function.
Education, Qualifications, Skills and Experience
Essential
- Life Sciences degree in an appropriate discipline.
- Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or CRO environment
- Ability to advise and lead communication projects
- Understands drug development and communication process from development, launch through life cycle management.
- In depth knowledge of the technical and regulatory requirements related to the role
- Extensive experience in clinical programs, study design and data analysis
Desirable
- Advanced degree in a scientific discipline (PhD)
- Expert reputation within the business and industry
- Extensive knowledge of the latest technical and regulatory expectations
