Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
Post : Global Regulatory Writing Manager
Role Description
To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.
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
Candidate Profile
• Doctorate degree OR
• Master’s degree and 3 years of directly related experience OR
• Bachelor’s degree and 5 years of directly related experience OR
• Associate’s degree and 10 years of directly related experience OR
• High school diploma / GED and 12 years of directly related experience
• Experience with regulatory documents in Regulatory Affairs, Research, Development, or related area
• 5+ years experience in medical writing in the Biotech/Pharmaceutical industry
• 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.
• 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
Additional Information
Experience : 3+ years
Qualification : Doctorate degree OR Master’s degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-202300
End Date : 20th January 2025
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