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Technical Resources International
Bethesda, MD, United States
Job Title MANAGER, REGULATORY AFFAIRS Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Applicatio
Job Source: Technical Resources InternationalTechnical Resources International
Bethesda, MD, United States
Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application
Job Source: Technical Resources InternationalJohns Hopkins Medicine
Bethesda, MD, United States
The Johns Hopkins Health System Corporation is a not-for-profit organization dedicated to providing the highest quality of care in the treatment and prevention of human illness. JHHS is an academically based health system consisting of: The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Johns Hopkins Howard County Medical Center, Sub
Job Source: Johns Hopkins MedicinePhilip Morris USA
Washington, DC, United States
Manager Regulatory Affairs Be a part of a revolutionary change At PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. We can now provide legal a
Job Source: Philip Morris USAJTI Inc
Washington, DC, United States
We're JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from . It's how we've grown to be present in 130 countries. But our business isn't just busine
Job Source: JTI IncJTI
Washington, DC, United States
Search by keyword and location and click "create alert" to receive your job alerts by email: Select how often (in days) to receive an alert: Professional area: Corporate Affairs & Communications Contract type: Permanent Professional level: Experienced Location: Washington, DC, US, 00000 We’re JTI, Japan Tobacco International and we beli
Job Source: JTIHR Retail
Bethesda, MD, United States
Regulatory Affairs Manager - (MGRRA_COMPANY_1) Share this job as a link in your status update to LinkedIn. Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multip
Job Source: HR RetailJT International S.A.
Washington, DC, United States
We're JTI, Japan Tobacco International and we believe in freedom . We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from . It's how we've grown to be present in 130 countries. But our business isn't just busine
Job Source: JT International S.A.Washington, DC, United States
**HOW MIGHT YOU DEFY IMAGINATION?**
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Regulatory Writing Manager**
**Live**
**What you will do**
Lets do this. Lets change the world. In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards.
+ Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)
+ Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
+ Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
+ Lead study timelines for regulatory documents and regulatory submission strategy
+ Act as a functional area representative and lead on product teams
+ Assist with the following activities: hiring, resourcing therapeutic areas and project teams, and departmental governance
+ Ensure quality of regulatory submission documents at all stages of development
+ Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams
+ Participate in departmental meetings, as well as departmental and cross-departmental initiatives
**Win**
**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
**Or**
Masters degree and 3 years of Writing Regulatory or scientific submission/documents experience
**Or**
Bachelors degree and 5 years of Writing Regulatory or scientific submission/documents experience
**Or**
Associates degree and 10 years of Writing Regulatory or scientific submission/documents experience
**Or**
High school diploma / GED and 12 years of Writing Regulatory or scientific submission/documents experience
**Preferred Qualifications:**
+ Masters or higher degree in biology, chemistry, or other scientific field
+ 5+ years in writing clinical and regulatory documents
+ Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
+ Ability to analyze medical data and interpret its significance
+ Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
+ Strong written/oral communication skills and attention to detail
+ Understanding and application of principles, concepts, theories, and standards of scientific/technical field
+ Strong time and project management skills, engaging approach, and perseverance with a drive for results
+ Leadership skills and ability to guide and influence the work of others
+ Strong leadership in a collaborative team environment
**Thrive**
**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.
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 plan
+ Stock-based long-term incentives
+ Award-winning time-off plans and bi-annual company-wide shutdowns
+ Flexible work models, including remote work arrangements, where possible
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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.
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Email Alert for Regulatory Affairs Manager jobs in Washington, DC, United States
ⓘ There was an unexpected error processing your request.
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