Job Order: 6026
Staff Representative: Tim Jadwin
Position: Clinical Development & Regulatory Affairs Consultant
Location: Work At Home
Company Summary:
Fully integrated, health science communications company that provides unparalleled scientific and medical communication services.
Description:
JOB SUMMARY:
Responsible for providing consultation/strategic input on regulatory processes for FDA and CPMP submissions. Execute content development of scientific materials required for regulatory submissions and presentations. Day-to-day management and training and development of regulatory and clinical services team members.
Management & Leadership:
- Provide strategic and tactical direction for products
- Supervise, inspire, and train staff
- Communication between team members about projects
- Client and faculty communication (written and verbal)
- Assist in training and mentoring efforts of new medical writers and regulatory affairs personnel
- Assist in recruiting efforts
- Responsible and accountable for understanding and meeting client needs and satisfaction
- Consult with clients, etc. on regulatory processes for FDA and CHMP submissions
- Responsible for the moderation of client meetings and for training client teams on preparations for FDA and advisory committee meetings
- Develop presentations for FDA and CHMP meetings including strategic advice relating to content, slide and script writing
- Interpretation and creative application of guidance and regulations
- Research adequate regulatory and competitive intelligence
- Assist in clinical development planning
- Participation in new business development and assistance with business pitches
- Oversee on-going archive of regulatory guidelines
- Continuing education in regulatory guidelines through training courses, publication review, etc.
- Ensure timely client deliverables
- Manage budget to stay within scope of projects
- Accurate and timely timesheet reporting
- Advanced degree in the life sciences, preferably MD or PhD/MPH
- Solid understanding of the drug/biologic development process, the FDA environment, and the challenges facing the pharmaceutical industry
- At least 8 years experience in early and late phase drug/biologic development
- Experience with clinical trial design and execution
- Working knowledge of basic statistical concepts
- Solid understanding of clinical and regulatory guidelines for drug development
- Active participation in periapproval activities
- Excellent communications skills (oral and written)
- Driven to complete projects to the highest standards
- Aptitude and willingness for hands-on work on project deliverables
- Solution oriented and comfortable in a fast paced environment
- Strong organizational and interpersonal skills
- Ability to work independently and within a team setting
- Ability to travel up to 40% (somewhat dependent on location of the potential employee)
- Computer proficiency (Outlook, Word, PowerPoint)
