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Amgen Inc
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Manager, Global Regulatory Writing

Manager, Global Regulatory Writing

Amgen Inc

9 - 13 years

16 - 20 Lacs

hyderabad

Posted:2 days ago| Platform:

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Skills Required

technical writing gcp analytical project management standard operating procedures clinical development oncology mentor ms office supervision

Work Mode

Work from Office

Job Type

Full Time

Job Description

What you will do Let s make an impact. Let s change the world. In this crucial role, youll cultivate strong business relationships with key cross-functional team members. You may also take on the role of functional area lead on product teams, oversee writing activities for product submissions (with supervision), mentor and train junior writers, and support various departmental initiatives as needed.

Roles Responsibilities:

Prepare regulatory submission documents as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents
Perform the formal review and approval of authored documents, ensuring compliance with applicable standard operating procedures
With significant supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications and biologics license applications
Act as the functional area lead on product teams, such as the Global Regulatory Team, Evidence Generation Team, Global Safety Team, and Label Working Group.
May contribute functional area input to the Global Regulatory Plan and team objectives
May collaborate with contract and freelance writers.
May assist in training and mentoring junior medical writers.
May contribute to departmental and cross-departmental initiatives, as needed.
Develop document timelines with input from the team.
Stay up to date with relevant professional information and emerging technologies.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

9-13 years of directly related experience

Preferred Qualifications:

Functional Skills:

Proficiency with word processing and other Microsoft Office Programs
Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
Ability to understand and follow complex standard operating procedures (SOP s), guidance documents, and work instructions
Understanding and application of principles, concepts, theories and standards of scientific/technical field
Substantial knowledge and understanding of International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidance s and requirements

Soft Skills:

Excellent written/oral communication skills and attention to detail
Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
Proficient time and project management skills.
Self-starter with a drive and perseverance to achieve results

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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Manager, Global Regulatory Writing