Global Regulatory Writing Manager

3 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

Roles & Responsibilities:

- Author 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;
- Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
- With considerable supervision, manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications;
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
- May provide functional area input for Global Regulatory Plan and team goals
- May work with contract and freelance writers
- May participate in training and mentoring of junior medical writers
- May participate in departmental and cross-departmental initiatives, as appropriate.
- Generate document timelines, with team input
- Keep abreast of relevant professional information and technology

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:

- Doctorate degree OR
- Master's degree and 4 to 6 years of directly related experience OR
- Bachelor's degree and 6 to 8 years of directly related experience OR
- Diploma and 10 to 12 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

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