Director, Global Regulatory Writing
Location: Hyderabad, India (On-Site)
Category: Regulatory
Date Posted: February 5, 2025
Director, Global Regulatory Writing:
What you will do
Let’s do this. Let’s change the world. In this vital role, you will oversee regulatory writing staff and projects across one or more therapeutic areas, ensuring the delivery of high-quality scientific and regulatory submission documents.
Lead the preparation, review, and approval of scientific and regulatory submission documents.
Serve as the functional area lead on cross-functional product teams.
Build and maintain strong business relationships with cross-functional team members and management within Amgen’s R&D organization.
Provide expertise and guidance on document design and medical writing principles to staff, product teams, and other functional areas.
Supervise, train, coach, and mentor regulatory writers.
Manage the work of contract writers and CROs assigned to program documents.
Oversee day-to-day departmental operations, including project resourcing, hiring, training, process development, and business operations.
Support executive leadership with resource and budget planning and departmental management activities.
What we expect of you
We believe that diverse perspectives and experiences drive innovation. We seek a Regulatory Writing professional who is a dynamic leader with the following qualifications:
Required Qualifications:
Doctorate degree and 4 years of directly related experience OR
Master’s degree and 8 years of directly related experience OR
Bachelor’s degree and 10 years of directly related experience
Key Skills and Experience:
In-depth understanding of global regulatory requirements and the ability to apply them to a dynamic and evolving environment.
Proven leadership in motivating, negotiating, collaborating, and making sound analytical judgments within a team setting.
Expertise in analyzing scientific data and translating its significance into practical applications.
Excellent written and verbal communication skills with exceptional attention to detail.
Strong project management skills, with the ability to manage multiple priorities effectively.
Experience supervising and developing direct reports, with a focus on delegation and mentoring.
Advanced knowledge of scientific writing, clinical development processes, and regulatory industry standards.
Comprehensive understanding of Amgen’s commercialization process and the core business functions supporting product development.
Thrive
What you can expect of us
At Amgen, we invest in your growth, well-being, and career aspirations. Here’s what you can expect:
Opportunities to learn, grow, and advance within our global organization.
A diverse, inclusive community where ideas are valued, and you are empowered to act.
A competitive Total Rewards Plan, including health, finance, wealth, work/life balance, and career development benefits.
Apply now
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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