Medical Writing Manager, Late Phase
2 settimane fa
The Medical Writing Manager, Late Phase will provide management of direct reports. Manage and develop medical writing staff. Contribute to and oversee resource planning and project assignments. Oversee medical writing processes and projects to ensure production of high quality deliverables. Responsible for preparation and coordination of clinical and regulatory documents. Provides medical writing leadership and advice to clients and internal Labcorp Drug Development project teams. Support client and business development activities. Provide review and feedback on documents prepared by the department.
**Your main duties and responsibilities will include but not be restricted to**:
- Lead Medical Writing team on large-scale (multiple document) writing projects. Provide direction to less experienced writers.
- Consistently demonstrate ability to operate independently on any assigned project and deliver on time, quality and budget metrics.
- Prepare documents in accordance with Labcorp Drug Development /Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
- Advise and support senior management in resolution of significant medical writing related problems.
- Demonstrate ability to resolve complex medical writing issues independently, while keeping management informed.
- Provide review and feedback on deliverables prepared by medical writing staff.
- Advise management on ideas to improve the efficiency and quality of work processes.
- Prepare and/or review global SOPs, as necessary.
- Build and maintain good relationships across functional units in Labcorp Drug Development.
- Provide support for Business Development opportunities by participating in proposal development, providing time and cost estimates, and attendance at bid defense meetings.
- Assist management in assessing department needs and developing new procedures and services.
- To assume line management responsibility for nominated staff in absence of Manager.
- To lead the development and presentation of relevant training courses for Medical Writers and other Operational Staff, as required.
- Comply with Labcorp Drug Development internal processes and procedures.
**Education / Qualifications**:
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
**Experience**:
- Minimum 8 years medical writing experience including 5 years as medical writing project lead.
- Excellent command of written and spoken English.
- Excellent written and verbal communication skills.
- Excellent knowledge of MS Word.
- Excellent organizational and time management ability.
- Excellent knowledge of ICH guidelines applicable to medical writing and other regulatory guidances.
- Excellent understanding of medical/scientific terminology, data analysis and interpretation.
- Good appreciation of the business requirements of a contract research organization.
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