Director Global Regulatory Writing

3 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

- Prepare and oversee the review and approval of scientific and regulatory submission documents.
- Serve as functional area lead on product teams.
- Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization.
- Provide expertise and guidance on document design and principles of good medical writing to individual staff, the department, product teams, and other functional areas.
- Supervise, train, coach, and mentor regulatory writers.
- Oversee the work of contract writers and CROs assigned to program documents.
- Manage and implement day-to-day departmental activities and operations, including hiring; resourcing projects; leading or participating in cross-functional process development, training, and oversight; business process ownership; and meeting management.
- Assist executive leadership with resource and budget planning and other department management activities, as needed.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory Writing professional we seek is a leader with these qualifications.

Required experience includes:

- 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

The successful candidate will have the following skills:

- Experience reading, understanding, and applying regulations to a constantly changing environment.
- Proven leader in a team environment which requires motivation, negotiation, persuasion, collaboration, and analytical judgment.
- Expertise in analyzing scientific data and interpreting its significance in practical applications.
- Excellent written/oral communication skills and attention to detail.
- Superior time and project management skills.
- Self-starter demonstrating perseverance with a drive for results.
- Strong management and supervisory skills with previous experience developing and delegating to direct reports.
- Advanced knowledge of scientific writing and editing and a detailed knowledge of the clinical development process for new compounds.
- Advanced knowledge of related regulatory/industry considerations and guidelines, compliance issues, and/or issues affecting scientific discovery.
- Advanced understanding and application of principles, concepts, theories, and standards of the scientific/technical field.
- Recognized as a functional-area/subject-matter expert within a defined subject area.
- Applies expert knowledge and broad understanding of multiple disciplines to achieve efficiencies.
- Understands the core business process and purpose of the functional area in Amgen's commercialization process.

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