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Mushroom Solutions

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5.0

based on 2 Reviews

5 Mushroom Solutions Jobs

Regulatory Affairs and Compliance Specialist and Product Specialist

Mushroom Solutions

5.0

based on 2 Reviews

3-6 years

Hyderabad / Secunderabad

1 vacancy

Regulatory Affairs and Compliance Specialist and Product Specialist

Mushroom Solutions

posted 5mon ago

Job Role Insights

Key skills for the job

Clinical Research Auditing Life Sciences Analytical Chemistry French Language Clinical Trials

+ 3 more

Job Description

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