Current jobs related to Regulatory Writing Senior Manager - Washington DC - Amgen

  • Regulatory Writing Manager

    3 weeks ago

    Washington, Washington, D.C., United States Amgen Full time

    Unlock Your Potential as a Regulatory Writing Manager at AmgenAre you a skilled writer with a passion for regulatory affairs? Do you want to make a meaningful impact in the biotechnology industry? Amgen is seeking a talented Regulatory Writing Manager to join our team!About the Role:As a Regulatory Writing Manager, you will be responsible for preparing and...

  • Regulatory Writing Specialist

    3 days ago

    Washington, Washington, D.C., United States Amgen Full time

    Amgen Internship OpportunityAmgen is a leading biotech company dedicated to serving patients with serious illnesses. As a Regulatory Writing Specialist, you will play a crucial role in preparing scientific and regulatory submission documents that comply with global regulatory standards.Key Responsibilities:Understand and comply with SOPs, templates, best...

  • Regulatory Writing Graduate Intern

    2 days ago

    Washington, Washington, D.C., United States Amgen Full time

    Amgen is a leading biotech company dedicated to improving the quality of life for people around the world. As a Regulatory Writing Graduate Intern, you will play a crucial role in helping us achieve this mission.Key Responsibilities:Prepare scientific and regulatory submission documents that comply with global regulatory standards.Understand and comply with...

  • Regulatory CMC Manager

    1 month ago

    Washington D.C., United States Amgen Full time

    Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...

  • Regulatory CMC Manager

    4 weeks ago

    Washington D.C., United States Amgen Full time

    Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading...

  • Associate General Counsel, Regulatory

    2 months ago

    Washington, United States Financial Industry Regulatory Authority (FINRA) Full time

    This position is responsible for directing and managing the complete life cycle of the adoption of new regulatory requirements. The incumbent provides expert knowledge to the Board of Governors and senior management, advising them on high-impact, legally and politically complex and sensitive regulatory initiatives and rule changes. This position is...

  • Senior Regulatory Attorney

    4 weeks ago

    Washington, Washington, D.C., United States U.S. Bank Full time

    Job Title: Senior Regulatory AttorneyU.S. Bank is seeking a highly skilled Senior Regulatory Attorney to join our Legal Regulatory Group. As a key member of our team, you will provide regulatory legal advice to senior management on new products and services, rulemakings, strategic business and regulatory initiatives, and supervisory...

  • Regulatory Attorney

    3 days ago

    Washington, United States Federal Energy Regulatory Commision Full time

    Job Summary: We are seeking a highly skilled Regulatory Attorney to join our team at the Federal Energy Regulatory Commission. As a key member of our Office of General Counsel, you will play a critical role in advising on complex legal matters related to public utilities.Key Responsibilities:Apply relevant experience and professional knowledge to case...

  • Senior Manager, Lead for U.S. Regulatory Policy

    1 week ago

    washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Senior Director – Law

    5 months ago

    Washington, United States PhRMA Full time

    Overview The Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director in the Law Department. The Senior Director will serve as regulatory counsel and provide both legal counsel and advocacy support along with other members of the Law team on issues relating to the regulation and approval of biopharmaceutical products...

  • Senior Manager, Lead for U.S. Regulatory Policy

    3 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Senior Manager, Lead for U.S. Regulatory Policy

    3 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Senior Manager, Lead for U.S. Regulatory Policy

    3 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Senior Manager, Lead for Regulatory Policy

    3 days ago

    Washington, Pennsylvania, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a highly skilled Senior Manager, Lead for U.S. Regulatory Policy to develop and implement the organization's regulatory policy strategy.As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S., Europe, and rest of world issues of a regulatory and policy nature impacting the plasma-derived therapies industry.Key...

  • Senior Manager, Lead for Regulatory Policy

    2 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    Job SummaryPPTA seeks a highly skilled Senior Manager, Lead for U.S. Regulatory Policy to lead the development and implementation of the organization's U.S. regulatory policy strategy.Key ResponsibilitiesDevelop and execute a comprehensive U.S. regulatory policy strategy to advance the interests of the plasma-derived therapies industry.Collaborate with...

  • Senior Regulatory Paralegal

    3 days ago

    Washington, United States Jobot Full time

    Job Title: Senior Regulatory ParalegalWe are seeking a highly skilled Senior Regulatory Paralegal to join our team at a nationally recognized law firm. As a key member of our busy worldwide antitrust practice, you will assist with regulatory filings, document preparation, and client support.Job Summary:The ideal candidate will have direct experience in...

  • Senior Regulatory Attorney

    1 week ago

    Washington, United States US Bank Full time

    At U.S. Bank, we're committed to excellence in all aspects of our business. As a Senior Regulatory Attorney, you'll play a key role in providing expert legal counsel to our clients and colleagues, ensuring compliance with regulatory requirements and advancing our business objectives. Your expertise will be invaluable in navigating complex regulatory issues...

  • Senior Regulatory Attorney

    1 month ago

    Washington, United States US Bank Full time

    Job DescriptionAt U.S. Bank, we're committed to creating a diverse workforce and fostering a culture of inclusion. We're seeking an experienced attorney to join our Legal Regulatory Group (LRG), providing legal support to senior management on new products and services, rulemakings, strategic business and regulatory initiatives, and supervisory matters.The...

  • Senior Director – Regulatory Counsel

    1 month ago

    Washington, Washington, D.C., United States PhRMA Full time

    Job Title: Senior Director – Regulatory CounselThe Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a highly skilled Senior Director to join our Law Department. As a key member of our team, you will serve as regulatory counsel and provide legal counsel and advocacy support on issues related to the regulation and approval of...

  • Regulatory Compliance and Risk Management Expert

    3 days ago

    Washington, Washington, D.C., United States KPMG Full time

    Job Summary:KPMG is seeking a highly skilled Manager to join our Advisory Services team in the Capital Markets practice. The ideal candidate will have a strong background in regulatory compliance and risk management, with a minimum of five years of experience in a related field.Key Responsibilities:Develop and implement compliance and risk management...

Regulatory Writing Senior Manager

3 months ago

Washington DC, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Regulatory Writing Senior ManagerLive

What you will do

Lets do this. Lets change the world. In this vital role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include:

  • Author or oversee the authoring of all 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 the formal review and approval of authored documents, following applicable standard operating procedures
  • With limited supervision, lead regulatory writing activities for complex 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)
  • Provide functional area input for Global Regulatory Plan and team goals
  • Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
  • Lead departmental and cross-departmental initiatives, as appropriate
  • Generate document timelinesWin

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:

    Doctorate degree 2 years of directly related experienceOr

    Masters degree and 6 years of directly related experienceOr

    Bachelors degree and 8 years of directly related experienceOr

    Associates degree and 10 years of directly related experienceOr

    High school diploma / GED and 12 years of directly related experiencePreferred Qualifications:

  • Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area5+years of experience in medical writing in the Biotech/Pharmaceutical industryThrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 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 accommodation.