Regulatory Writing Sr Mgr Washington
Position: Regulatory Writing Sr Mgr Job at BioSpace in Washington
Regulatory Writing Sr Mgr Job at Bio Space in Washington Bio Space
• Washington, DC, United States
Join to apply for the Regulatory Writing Senior Manager role at Amgen.
At Amgen, our shared mission to serve patients drives everything we do. We strive to become one of the world’s leading biotechnology companies, collaborating globally to research, manufacture, and deliver ever‑better products that reach over 10million patients worldwide. It is time for a career you can be proud of.
What You Will Do
In this key 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 junior writers, and lead departmental activities.
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 Module2 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.
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 and 2 years of directly related experience
• Masters degree and 6 years of directly related experience
• Bachelors degree and 8 years of directly related experience
• Associates degree and 10 years of directly related experience
• High school diploma / GED and 12 years of directly related experience
Preferred Qualifications
• Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
• 5+ years of experience in medical writing in the Biotech / Pharmaceutical industry
What You Can Expect Of Us
We work to develop treatments that take care of others while also caring for our teammates’ professional and personal growth and well‑being. 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.
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 plan.
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
Flexible work models, including remote work arrangements, where possible.
Application
Final date to receive applications :
Amgen does not have an Final date to receive applications for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Apply now for a career that defies imagination at
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.
J-18808-Ljbffr
#J-18808-Ljbffr
Apply Now
Apply Now
Regulatory Writing Sr Mgr Job at Bio Space in Washington Bio Space
• Washington, DC, United States
Join to apply for the Regulatory Writing Senior Manager role at Amgen.
At Amgen, our shared mission to serve patients drives everything we do. We strive to become one of the world’s leading biotechnology companies, collaborating globally to research, manufacture, and deliver ever‑better products that reach over 10million patients worldwide. It is time for a career you can be proud of.
What You Will Do
In this key 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 junior writers, and lead departmental activities.
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 Module2 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.
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 and 2 years of directly related experience
• Masters degree and 6 years of directly related experience
• Bachelors degree and 8 years of directly related experience
• Associates degree and 10 years of directly related experience
• High school diploma / GED and 12 years of directly related experience
Preferred Qualifications
• Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
• 5+ years of experience in medical writing in the Biotech / Pharmaceutical industry
What You Can Expect Of Us
We work to develop treatments that take care of others while also caring for our teammates’ professional and personal growth and well‑being. 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.
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 plan.
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
Flexible work models, including remote work arrangements, where possible.
Application
Final date to receive applications :
Amgen does not have an Final date to receive applications for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Apply now for a career that defies imagination at
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.
J-18808-Ljbffr
#J-18808-Ljbffr
Apply Now
Apply Now