Sr. Scientist

Submit Your Resume/CV

About the role

As an Associate Director/Director, Clinical Operations Compliance, you will be responsible for overseeing clinical operations compliance within a biopharmaceutical company. This role is based in Cambridge, Massachusetts.

Responsibilities

• Oversee and ensure adherence to regulatory standards and guidelines for clinical operations
• Develop and implement policies and procedures to maintain compliance
• Manage and mentor a team of compliance professionals
• Conduct audits and assessments to identify areas for improvement
• Collaborate with cross-functional teams to ensure compliance with clinical trial protocols

Requirements

• Bachelor's degree in a relevant field (e.g., Biomedical Engineering, Pharmaceutical Sciences)
• Minimum 10 years of experience in clinical operations compliance
• Proven track record of successful audit and assessment management
• Strong leadership and mentoring skills
• Experience with regulatory bodies such as FDA and EMA

Qualifications

• Advanced degree in a relevant field (Ph.D. preferred)
• Experience in pharmacovigilance safety operations
• Excellent communication and interpersonal skills
• Ability to work independently and manage multiple projects simultaneously

Skills

• Strong knowledge of regulatory requirements and guidelines
• Experience with clinical trial protocols and processes
• Proficiency in project management tools and software
• Excellent analytical and problem-solving skills

Benefits

• Competitive compensation package
• Flexible working arrangements
• Professional development opportunities

Pay

Salary range is $120,000 - $150,000 per year, commensurate with experience.

Schedule

Full-time position, 40 hours per week.

Benefits

• Health insurance
• Retirement plan
• Employee assistance program

Contact Information

To apply, please submit your resume/CV along with a cover letter detailing your interest in this position and how your background aligns with the requirements and responsibilities outlined above.