Amgen

Clinical Trials Disclosure Assoc Director

Amgen

Hyderabad, Telangana, India
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to the world of innovative biotechnology and join us as the Clinical Trials Disclosure Associate Director at Amgen. In this role, you will play a critical part in ensuring the timely and accurate disclosure of clinical trial information to the public and regulatory agencies. We are looking for a highly motivated individual with a strong attention to detail and a passion for compliance and transparency. As a member of our dynamic team, you will have the opportunity to work on cutting-edge clinical trials and contribute to the advancement of medical research. If you have a background in life sciences, strong project management skills, and a commitment to upholding ethical standards, we invite you to apply for this exciting opportunity. Join us in our mission to serve patients and make a meaningful impact on the world of healthcare.

  1. Ensure timely and accurate disclosure of clinical trial information to the public and regulatory agencies.
  2. Develop and implement processes and procedures to ensure compliance with clinical trial disclosure requirements.
  3. Manage and oversee the operational aspects of clinical trial disclosure, including tracking and reporting of data.
  4. Collaborate with cross-functional teams to ensure consistency and accuracy of clinical trial information.
  5. Monitor industry trends and regulations related to clinical trial disclosure and make recommendations for process improvements.
  6. Serve as a subject matter expert on clinical trial disclosure regulations and policies.
  7. Train and educate team members on clinical trial disclosure requirements and processes.
  8. Maintain up-to-date knowledge of the company's clinical trial portfolio and changes in trial status to ensure accurate and timely disclosure.
  9. Ensure all disclosure activities are conducted ethically and in accordance with company and regulatory standards.
  10. Communicate with external stakeholders, including regulatory agencies and the public, regarding clinical trial disclosure information.
  11. Contribute to the development of strategies to improve clinical trial transparency and compliance.
  12. Participate in audits and inspections related to clinical trial disclosure and ensure timely and accurate responses to any findings.
  13. Manage and maintain databases and systems used for clinical trial disclosure.
  14. Collaborate with internal and external partners to continuously improve processes and systems for clinical trial disclosure.
  15. Represent the company at conferences and other events related to clinical trial disclosure.
Where is this job?
This job is located at Hyderabad, Telangana, India
Job Qualifications
  • Bachelor's Degree In A Relevant Field Such As Life Sciences, Healthcare, Or Business Administration.

  • Minimum Of 5 Years Of Experience In Clinical Trial Disclosure, With Demonstrated Expertise In Regulatory Requirements And Industry Best Practices.

  • Strong Project Management Skills, With The Ability To Lead Cross-Functional Teams And Ensure Timely And Accurate Disclosure Of Clinical Trial Information.

  • Excellent Understanding Of Clinical Trial Data Management, Including Experience With Clinical Trial Databases And Data Analysis.

  • Familiarity With Industry Standards And Regulations Related To Clinical Trial Disclosure, Including Fda And Ema Requirements, And Experience In Developing And Implementing Disclosure Policies And Procedures.

Required Skills
  • Quality Assurance

  • Process Improvement

  • Communication Skills

  • Project Management

  • Data Analysis

  • Clinical Research

  • Database Management

  • Reporting skills

  • Team Leadership

  • Risk assessment

  • Regulatory compliance

  • Protocol Review

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Organization

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Clinical Trials Disclosure Assoc Director in Hyderabad, Telangana, India is between ₹2,000,000 to ₹3,500,000 per year. However, this can vary depending on factors such as the company, years of experience, and specific job responsibilities.

Additional Information
Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesHindi
Job PostedDecember 13th, 2024
Apply BeforeApril 11th, 2026
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About Amgen

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.

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