For The Candidates

(216) Area Code  Cleveland   Clinical and Regulatory Leader 

REPORTING STRUCTURE:        COO, Scientific & Regulatory Communications

JOB SUMMARY:

Responsible for providing consultation/strategic input on regulatory processes for FDA and CHMP 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

Team and Client Relations:

·        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

Functional:

• 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.

Fiscal Responsibility:

·        Ensure timely client deliverables

·        Manage budget to stay within scope of projects

·        Accurate and timely timesheet reporting

-Other Duties as Assigned-

QUALIFICATIONS OF POSITION

• 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)