Clinical Trials Disclosure Mgr

eholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting

• Support trend analysis and continuous improvement initiatives

• Manage projects, coordinate the work of other staff, and prioritize work in order to meet internal and external deadlines

Required Skills:

• Experience understanding and interpreting data/information and its practical application

• Working experience with redaction/anonymization of clinical trial documents e.g. for EU CTR, HC-PRCI

• Working experience with disclosures on public registries e.g. ClinicalTrials.gov

• Self-motivated with developed skills in multi-tasking, attention to detail, and follow-through

• Good communication skills including excellent spoken and written English

• Ability to follow controlled processes

• Leadership skills, including ability to teach, negotiate and influence

• Project management skills, including ability to prioritize work in order to meet required deadlines

• Problem solving ability

• Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolution

Basic Qualifications:

• Graduate degree and 2 years of relevant work experience in the pharmaceutical industry

OR

• Bachelor's degree, and 4 years relevant work experience in the pharmaceutical industry

• Minimum of 2 years experience in preparation of regulatory documents for public disclosure

• Familiarity with international regulations, guidance and best practices on clinical transparency & disclosure, including protection of personal information and commercially confidential information

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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