Works directly with GRA senior management and business development directors to propose, defend, and then lead awarded complex multi-functional projects. Involvement in leading proposal and bid defense efforts for complex regulatory projects and molecule development teams. Manage molecule development teams. Candidate works independently within the GRA and enterprise organizations. Additional responsibilities include leading resolution of functional and cross-functional issues, cross-project and financial processes improvements, and departmental initiatives; managing and/or mentoring project managers and teams on improving project performance; and taking on special projects as deemed appropriate by GRA Leadership.
Essential Job Duties:
- Manage complex multi-functional regulatory projects
- Manage molecule development teams
- Involvement in leading proposal and bid defense efforts for complex regulatory projects and molecule development teams
- Participate in and/or lead business development activities to increase business for regulatory services and enterprise molecule development work
- Participate in or lead cross-functional initiatives
- Contribute to GRA materials for proposal templates, business development training, and GRA capabilities overview
- Identify, promote and implement best practices for GRA driving for sustainable competitive advantage
- Work with CTMO, Therapeutic Area, and GRA Leadership to:
- Recommend areas of improvement across clients to enhance operational performance
- Lead improvement processes and ensure implementation throughout the organization
- Accountable for GRA Regulatory Project Management Staff
- Lead special projects, as assigned by GRA Leadership Team members
- Perform other duties as assigned by GRA Leadership
- University/college degree (life science preferred), business, project management or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
- A good understanding of the drug development process.
- Knowledge of Covance and the overall structure of the organization
- Knowledge of Covance business development strategies and procedures
- Working knowledge of Covance SOPs.
- At least 10 years experience in the pharmaceutical industry with 7 years preferably in Regulatory Affairs or in Drug Development.
- Demonstrated skills and competency in project management tasks
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Broad knowledge of drug development process and client needs.
- Comprehensive understanding of processes associated with Global Regulatory Affairs activities
- Skilled in trouble-shooting and issue resolution
- Strong interpretation and analytical skills within and across projects / portfolios leading to documented efficiency improvements
- Ability to lead diverse cross-functional teams and deliver measurable results
- Experience in managing a project budget with documented cost containment strategies.
- Ability to work with minimal supervision.
- Excellent communication, facilitation and presentation skills
- Good conflict management skills
- Good computer skills with a working knowledge of a range of computer applications.
- Excellent planning, time management and organization skills.
- Ability to work efficiently and effectively in a matrix environment
- 5+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
- CRO/Pharmaceutical experience preferred, prior Covance experience a plus
- PMP certification.