Seagen

Clinical Trial Disclosure Specialist

Description

Summary

This position supports a senior CTD professional by executing against the global cross-project disclosure plan. Key responsibilities include maintaining an understanding of regulatory requirements to manage timely, accurate, consistent, and responsible disclosure of global clinical trial information.

Principal Responsibilities:

• Responsible for preparing routine clinical trial disclosure submissions to ensure compliance with defined timelines on public database registries (e.g., ClinicalTrials.gov)
• Represents CTD on clinical study teams for the initial registration and maintenance of applicable clinical trials on public database registries, including results reporting when appropriate
• May assist in disclosure of lay summaries and identification of personal private and company confidential information for health authority transparency submissions (e.g., EMA Policy 0070)
• Contributes to cross-functional operational activities supporting data requests from qualified researchers
• May perform research and assessments to inform global cross-project disclosure plan
• Contributes to process improvement by refining work instructions, training materials, and procedures as needed
• Stays informed of evolving policies and best practices in the area of clinical trial disclosure and transparency

Required Qualifications:

• Bachelor’s degree​
• 2-3 years’ experience in project management or related field
• Excellent written and verbal communication skills
• Strong organizational skills; able to manage conflicting priorities and adhere to tight timelines​
• Proven ability to work with a high level of integrity, accuracy, and attention to detail

Preferred Qualifications:

• 1 year in pharmaceutical or trial disclosure industry experience preferred
• General knowledge of the US drug development process and regulatory requirements​ desirable
• Experience with Adobe Acrobat, SmartSheet, Clinical Trial Management Systems, and SharePoint a plus

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/29/2021