Regulatory Writing Mgr

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let’s do this. Let’s change the world. In this vital role you will author and gain approval of scientific and regulatory submission documents that align 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.

• 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

We are all different, yet we all use our unique contributions to serve patients.

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:

• 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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.