Senior Manager - Regulatory Data Management

14-18 years

Not Disclosed

Hyderabad

10 Dec. 3, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Amgen’s Mission to Serve Patients

At Amgen, being part of something bigger is more than a feeling—it’s a reality. Our mission to serve patients living with serious illnesses inspires everything we do.

Since 1980, we’ve been at the forefront of biotech innovation, tackling some of the toughest diseases in the world. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we make a difference in the lives of millions of patients every year. As a valued member of the Amgen team, you’ll help us research, manufacture, and deliver innovative medicines that allow people to live longer, fuller, and happier lives.

Our award-winning culture emphasizes collaboration, innovation, and science. If you thrive on challenges and seek opportunities to grow, Amgen is the place for you. Join us to transform patient lives while advancing your career.

Senior Manager - Regulatory Data Management

Your Impact
The Global Submission and Information Management (GSIM) team provides strategic technical expertise to enhance operational excellence, innovation, and technical compliance in Amgen's regulatory submission and information management. Our mission is to ensure smooth, compliant data flows across internal teams, external partners, and regulatory authorities while driving process improvements, implementing digital technologies, and managing organizational change.

As Senior Manager of Regulatory Data Management, you’ll help shape and implement a system-based framework for regulatory data management. This pivotal role involves building and leading a high-impact team, collaborating with GSIM leadership, and engaging with cross-functional partners to optimize Amgen's Regulatory Information Management system.

Responsibilities

Build and lead a global team delivering high-quality regulatory data management services.
Foster a collaborative, innovative, and inclusive team culture focused on continuous improvement.
Ensure operational metrics and compliance standards are consistently met with accuracy and efficiency.
Drive initiatives to enhance service delivery and streamline operational processes.
Establish policies and processes to minimize errors and ensure proper data usage.
Supervise the delivery of superior data processing, system utilization, and management services to global stakeholders.
Develop and implement comprehensive training programs to empower team members with expertise in regulatory data management practices.
Stay updated on regulatory developments and ensure the team adheres to all relevant standards and regulations.

What We’re Looking For

Basic Qualifications

Doctorate degree with 2+ years of regulatory systems experience, OR
Master’s degree with 8-10 years of regulatory systems experience, OR
Bachelor’s degree with 10-14 years of regulatory systems experience, OR
Diploma with 14-18 years of regulatory systems experience.
Advanced knowledge of Veeva Vault RIM.
Proven leadership in regulatory data management.
Expertise in managing structured and unstructured data.
Hands-on experience with data-centric processes and systems.
Strong skills in change management and customer engagement.

Preferred Qualifications

Experience ensuring compliance within a large organization.
Expertise in large-scale enterprise systems within the Biotech/Pharmaceutical industry.
5+ years of experience in regulatory operations and submission management.
Deep understanding of Regulatory Affairs’ complexities and process interdependencies.
Demonstrated success in building and leading high-performing teams.
Strong analytical thinking and learning agility.
Proven ability to interact effectively with global stakeholders.

What You Can Expect from Amgen

We support your professional growth, personal well-being, and overall development. With competitive benefits, a collaborative culture, and opportunities to thrive, we’ll help you achieve your career goals while making a difference for patients worldwide.

In addition to a competitive base salary, Amgen offers a comprehensive Total Rewards package aligned with industry standards.

Apply Today
Embark on a career that defies imagination. Visit careers.amgen.com to learn more.

Together, we innovate to serve patients. Join us and be part of the fight against serious diseases.

Amgen is an Equal Opportunity Employer
We welcome all qualified applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected status. If you require accommodations during the application or interview process, please contact us.

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Senior Manager - Regulatory Data Management

Job Description

Senior Manager - Regulatory Data Management

Responsibilities

What We’re Looking For

What You Can Expect from Amgen

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