Location: Gachibowli
Job Type: Full-Time
Experience Level: 3+ Years
Job Description:
Job Summary
We are seeking an experienced and detail-oriented Regulatory Affairs and Compliance Specialist and Product Specialist to join our Clinical Trials team. The successful candidate will be responsible for ensuring compliance with all regulatory requirements and standards for our solutions and for driving the market strategy and sales materials for these solutions. This role is critical to maintaining data integrity, protecting participant rights, achieving regulatory compliance, and effectively bringing our solutions to market.
Key Responsibilities
Regulatory Compliance
- Ensure adherence to FDA 21 CFR Part 11, EMA guidelines, ICH GCP, and other relevant regulations.
- Develop and maintain documentation to support regulatory submissions and audits.
- Monitor changes in regulatory requirements and update policies and procedures accordingly.
- Conduct internal audits to ensure compliance with regulatory standards and prepare for external audits.
Data Privacy and Security
- Implement and maintain compliance with GDPR, HIPAA, and other data privacy regulations.
- Ensure data minimization, obtain explicit consent from participants, and uphold data subject rights.
- Conduct Data Protection Impact Assessments (DPIAs) to identify and mitigate privacy risks.
- Establish and maintain security measures to protect sensitive data, including PHI.
System and Data Integrity
- Ensure systems adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
- Develop and implement procedures for source data verification and validation.
- Maintain comprehensive audit trails and ensure data traceability.
Validation and Documentation
- Oversee system validation, including defining requirements, conducting testing, and maintaining documentation.
- Develop, review, and update Standard Operating Procedures (SOPs) for systems.
- Provide training to staff on regulatory requirements, SOPs, and compliance best practices.
Quality Assurance
- Implement quality assurance processes to ensure compliance with Good Clinical Practice (GCP) standards.
- Coordinate with cross-functional teams to ensure consistent protocol adherence across all sites.
- Monitor site performance and provide insights to optimize data collection efforts.
Product Specialist Responsibilities
- Develop a deep understanding of our solutions and their competitive positioning in the market.
- Create and maintain comprehensive sales materials, including presentations, product sheets, and case studies.
- Drive the development of sales strategies and pitches tailored to different customer segments.
- Provide training and support to the sales team, ensuring they are well-equipped to represent our solutions effectively.
- Collect and analyze customer feedback to inform product development and marketing strategies.
- Collaborate with the marketing team to develop compelling content and campaigns to drive product awareness and adoption.
Qualifications
Education and Experience
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Compliance, Marketing, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs, compliance, quality assurance, or product management within clinical trials or a related field.
- Experience with electronic data capture in clinical trials and product management is highly desirable.
Skills and Competencies
- In-depth knowledge of FDA 21 CFR Part 11, EMA guidelines, ICH GCP, GDPR, HIPAA, and other relevant regulations.
- Strong understanding of data privacy, security principles, and best practices.
- Proven ability to manage and execute system validation and compliance documentation.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and organizational skills.
- Effective communication and interpersonal skills, with the ability to train and guide staff.
- Proficiency in using compliance management software and tools.
- Strong marketing, sales, and product management skills.
Benefits
- Competitive salary and benefits package.
- Opportunity to work with a dynamic and innovative team.
- Professional development and career growth opportunities.
- Flexible work environment.
How to Apply
Interested candidates are invited to submit their resume and cover letter detailing their qualifications and experience to [email address] with the subject line “Regulatory Affairs and Compliance Specialist and Product Specialist Application.”
About Us
Mushroom Solutions is dedicated to advancing clinical trials through innovative solutions. Our mission is to streamline data collection, enhance compliance, and improve participant engagement to drive successful clinical research outcomes.