Senior Regulatory Writing Manager

Job not on LinkedIn

🕒 August 4

🇺🇸 United States – Remote

💵 $139.6k - $188.8k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Serve as the functional area lead on product teams • Lead writing activities for complex product submissions • Author or oversee regulatory submission documents, 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, and Pediatric Investigation Plans • Conduct formal review and approval of authored documents in accordance with applicable standard operating procedures • Lead regulatory writing activities for complex product submissions, including new and supplemental drug applications and biologics license applications • Provide functional area expertise and input for Global Regulatory Plans and team goals • Participate on Global Regulatory, Evidence Generation, Global Safety, and Label Working Group teams • Supervise contract and freelance writers and mentor junior medical writers • Lead departmental and cross-departmental initiatives • Generate document timelines

🎯 Requirements

• Doctorate degree and 2 years of directly related experience, or Master’s degree and 6 years, or Bachelor’s degree and 8 years, or Associate’s degree and 10 years, or high school diploma/GED and 12 years • Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area • 5+ years of experience in medical writing in the biotechnology or pharmaceutical industry • Ability to lead regulatory writing activities for complex product submissions • Knowledge of regulatory submission documents and applicable standard operating procedures • Experience serving as a functional area lead on product teams • Experience supervising contract and freelance writers and mentoring junior medical writers

🏖️ Benefits

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible • Career development opportunities • Work/life balance