All fees are paid by our clients. Our services are free to applicants.

Job Order:

5956

Staff Representative:

Tim Jadwin

Position:

Clinical Development & Regulatory Affairs Consultant

Location:

Ohio

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

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

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)

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