Company Introduction
At Amgen, we are dedicated to changing the world through innovative biotechnological advancements. As a leading global biotechnology company, we are committed to discovering, developing, and delivering innovative medicines to improve the lives of patients worldwide. With a rich pipeline of products, a commitment to excellence, and a collaborative work environment, we offer a unique opportunity for professionals in the life sciences to make a meaningful impact. Amgen is looking for a Global Regulatory Writing Manager to join our team, based in Hyderabad, India.
Responsibilities in the Job
As a Global Regulatory Writing Manager, you will play a critical role in ensuring the accurate and timely creation of regulatory submission documents. Your responsibilities will include:
- Authoring Regulatory Documents: Writing clinical documents such as Clinical Study Reports, Investigator Brochures, Informed Consent Forms, Clinical Overviews, and other regulatory documents.
- Document Review and Approval: Conducting formal reviews of authored documents, adhering to relevant standard operating procedures (SOPs).
- Product Submission Management: Managing regulatory writing activities for product submissions, including new drug applications and biologic license applications, with supervision.
- Team Leadership: Leading and providing functional area input for various product teams, such as the Global Regulatory Team and Evidence Generation Team.
- Mentoring and Training: Assisting in the training and development of junior writers and contributing to the success of departmental initiatives.
- Document Timelines: Generating timelines for regulatory submissions and coordinating with teams to ensure milestones are met.
- Stay Updated: Keeping up-to-date with relevant professional information and technology to enhance your contributions.
Qualifications
To qualify for the Global Regulatory Writing Manager position at Amgen, candidates must meet certain educational and professional criteria. These qualifications include:
- Educational Requirements:
- Doctorate degree, OR
- Master’s degree with 4 to 6 years of directly related experience, OR
- Bachelor’s degree with 6 to 8 years of directly related experience, OR
- Diploma with 10 to 12 years of directly related experience.
- Experience:
- Significant experience in scientific/technical writing and editing, particularly in the clinical development process for new compounds.
- Proficiency with Microsoft Office and word processing software.
Skills
Amgen is looking for professionals with a strong set of technical and interpersonal skills. These skills include:
- Technical Competence:
- Deep knowledge of ICH (International Council on Harmonization) guidelines, GCP (Good Clinical Practice), and regulatory requirements.
- Proficiency in document management systems and regulatory submission processes.
- Soft Skills:
- Excellent written and oral communication skills with attention to detail.
- Strong project management, organizational, and time management abilities.
- Ability to lead teams, negotiate, persuade, collaborate, and demonstrate analytical judgment.
- Self-motivated with a strong drive for achieving results.
How to Apply
If you’re ready to make a difference at Amgen, we invite you to apply for the Global Regulatory Writing Manager position. To start the application process, visit our careers website at careers.amgen.com, where you can submit your resume and cover letter.
Take this opportunity to be part of a team that is pioneering new treatments and changing the world of medicine. Apply now and embark on a rewarding career path with Amgen!
