Regulatory Writing Senior Manager Job at Amgen

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

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 timelines

What we offer

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

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

Senior Content Manager

Lead the development, review, and delivery of high-impact medical education cont...

Location

Canada , Toronto

Salary:

Not provided

Fullscript

Expiration Date

Until further notice

Requirements

8+ years in medical writing and editing, preferably with a focus on practitioner education
Deep understanding of scientific writing standards, editorial best practices, and regulatory requirements
Proven ability to write across modalities and tones—from protocols to presentations to podcast scripts
Confidence collaborating with freelancers and SMEs, setting expectations, and providing editorial direction
Familiarity with using AI tools to support content development, with strong human oversight

Job Responsibility

Create and oversee the development of evidence-informed educational content for healthcare professionals
Direct freelance medical writers, providing clear outlines, editorial guidance, and constructive feedback
Collaborate cross-functionally with internal teams and stakeholders to shape content formats and delivery strategies
Tailor content for diverse audiences and formats
Ensure quality and compliance by conducting or reviewing literature searches, validating accuracy of claims, reviewing for FTC/FDA compliance, and adhering to internal style and compliance guidelines
Conduct clear content intake processes to define context, audience, CME requirements, and format
Identify opportunities to improve workflows for editing, reviewing, and approving medical content
Ensure content quality and utility by measuring performance, applying insights, and adapting content to better meet user needs and maximize impact

Fulltime

Senior Manager Accreditation And Professional Regulation

Under the leadership of the Director, the Senior Manager, Accreditation and Prof...

Location

United States

Salary:

80336.75 - 140851.54 USD / Year

Adtalem Global Education

Expiration Date

Until further notice

Requirements

Master's Degree in nursing required
PhD in nursing or a related discipline preferred
Five years of teaching and/or management experience in a higher education setting and experience with assessment, accreditation and regulatory approval processes required
Demonstrated ability to establish and develop positive relationships with state agency personnel
Strong critical thinking skills to assess state requirements that may not be explicit
Strong interpersonal, organizational, writing, editing, and computer skills
Must be willing and able to travel up to 25%-30%, including occasional overnight or out-of-state trips, as business needs require

Job Responsibility

Relationship Building: Establish and nurture strong connections with state regulatory agencies to pave the way for new campus developments
Institutional Representation: Represent our institution to regulatory agencies, supporting both new campus initiatives and existing program changes
Regulatory Management: Oversee the approval processes for campus programs, including documentation, submission timing, visits, and responses
Collaborative Oversight: Work with the editor/writer to prepare and submit applications, self-studies, and reports, ensuring compliance with state nursing board requirements
Compliance Leadership: Ensure timely and appropriate handling of licensing and compliance issues in coordination with corporate departments
Expert Resource: Serve as a resource for the compliance department on State Boards of Nursing regulatory approval matters
Curriculum Guidance: Provide input on undergraduate prelicensure curriculum development to meet state and professional standards
Employee Qualification Assessment: Review and assess qualifications for new and existing campus staff, ensuring compliance with regulations
Advisory Committee Leadership: Establish and support new campus and online advisory committees, attending meetings as needed
Accreditation Support: Assist in the development and submission of professional accreditation change reports

What we offer

Health, dental, vision, life and disability insurance
401k Retirement Program + 6% employer match
Participation in Adtalem’s Flexible Time Off (FTO) Policy
12 Paid Holidays
Eligible to participate in an annual incentive program

Fulltime

Vice President, AML KYC GEDD - Periodic Transaction Review CRIU Senior Manager

The Periodic Transaction Review (“PTR”) process is designed to supplement and en...

Location

Malaysia , Kuala Lumpur

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

6-10 years’ experience related to performing enhanced due diligence reviews of high-risk accounts preferred
Anti-Money Laundering (AML) Certification
Previous supervisory experience
Efficient verbal and written communication skills
Experience using online search tools
Experience writing and preparing Suspicious Activity Reports (SARs)
Bachelor’s/University degree, Master’s degree preferred

Job Responsibility

Identify the Monthly Global PTR Population required to be produced in accordance to the scope and requirements, and assist with delivering formally to all regions
Assist in formally advising the key stakeholders of the client record renewal process, including relevant KYC Owners, of publication and availability of these reports for each region
Liaise with KYC Owners and the Business Support Unit on client records with issues (i.e. tech issues, renewal date shifts, etc.) on PTR Report production requirements, escalating to the proper channels where applicable, and advising the Global PTR Group to begin production when necessary
Frequently collaborate with regional PTR management / SMEs to gather feedback on all PTR Program initiatives, ensuring overall consistency in the process and procedures is in place, as well as for any implementation of new processes or changes to the program
Provide subject matter expertise of AML analysis and recommendations for the Relationship Managers, BSU and Local/Regional Compliance
Preparation of Suspicious Activity Reports (SARs) and recommend relationship retention or termination, and track account closures as required
Lead or participate in the development, implementation and/or maintenance of processes and procedures to ensure compliance with current regulatory guidance and Citi policy and achieves a “best in class” performance
Lead or participate in the hiring, training, mentoring and assessment processes related to employee candidates
Lead or participate in the development, testing, training and implementation of new or enhanced processes
Provide innovative, relevant, and substantial input on project-level initiatives in consideration of all regions in the Global PTR Program

What we offer

Citi provides programs and services for your physical and mental well-being including access to telehealth options, health advocates, confidential counseling and more
Citi provides access to an array of learning and development resources to help broaden and deepen your skills and knowledge as your career progresses

Fulltime

Vice President, AML KYC GEDD - Periodic Transaction Review CRIU Senior Manager

The Periodic Transaction Review (“PTR”) process is designed to supplement and en...

Location

Malaysia , Kuala Lumpur

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

6-10 years’ experience related to performing enhanced due diligence reviews of high-risk accounts preferred
Anti-Money Laundering (AML) Certification
Previous supervisory experience
Efficient verbal and written communication skills
Experience using online search tools
Experience writing and preparing Suspicious Activity Reports (SARs)
Bachelor’s/University degree, Master’s degree preferred

Job Responsibility

Identify the Monthly Global PTR Population required to be produced in accordance to the scope and requirements, and assist with delivering formally to all regions
Assist in formally advising the key stakeholders of the client record renewal process, including relevant KYC Owners, of publication and availability of these reports for each region
Liaise with KYC Owners and the Business Support Unit on client records with issues (i.e. tech issues, renewal date shifts, etc.) on PTR Report production requirements, escalating to the proper channels where applicable, and advising the Global PTR Group to begin production when necessary
Frequently collaborate with regional PTR management / SMEs to gather feedback on all PTR Program initiatives, ensuring overall consistency in the process and procedures is in place, as well as for any implementation of new processes or changes to the program
Provide subject matter expertise of AML analysis and recommendations for the Relationship Managers, BSU and Local/Regional Compliance
Preparation of Suspicious Activity Reports (SARs) and recommend relationship retention or termination, and track account closures as required
Lead or participate in the development, implementation and/or maintenance of processes and procedures to ensure compliance with current regulatory guidance and Citi policy and achieves a “best in class” performance
Lead or participate in the hiring, training, mentoring and assessment processes related to employee candidates
Lead or participate in the development, testing, training and implementation of new or enhanced processes
Provide innovative, relevant, and substantial input on project-level initiatives in consideration of all regions in the Global PTR Program

What we offer

Citi provides programs and services for your physical and mental well-being including access to telehealth options, health advocates, confidential counseling and more
Citi provides access to an array of learning and development resources to help broaden and deepen your skills and knowledge as your career progresses

Fulltime

Senior Change Management Business Analyst

Supports Non-Financial Regulatory Reporting project portfolio by planning and ex...

Location

United Kingdom , Belfast

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Significant financial services experience, especially in global markets trading and investment banking operations
Proven end to end change management expertise is required (e.g., Requirement elicitation, documentation and sign off, project planning including supporting the identification of Test data, oversight of Test scripts and being an SME for Business Stakeholders and Tech Teams of the change being managed)
Preferable to have experience of raising issues in JIRA and JIRA workflows, Agile and Waterfall project experience, data analysis skills, and ability to understand process/data workflows
Knowledge of capital markets products (cash securities, derivatives)
Expertise in non-financial regulatory reporting (e.g., CASS, DP, CFTC, SEC, EMIR, MiFID II/MiFIR)
Proven experience in successful project implementation and operational process improvement
Experience with cross-functional teams and documenting business/technology requirements and test plans
Consulting, stakeholder management, and conflict resolution skills
Technical understanding of securities processing (product, process, system)
Strong analytical skills for large datasets and proficiency in Microsoft Office, Visio, and Project

Job Responsibility

Gathering requirements, writing requirements, communicating requirements to technology
Support the Change Management Lead in the direct management of multiple regulatory reporting projects
Provide guidance and mentorship to junior team members
Work closely with business functions to execute necessary policy, process, and technology change
Liaise with Business Execution and Transformation teams
Support the governance of program/projects including facilitation of steering committee and working groups
Identify key project risks and escalate accordingly
Ensure that the delivery from the workstreams/projects meets requirements and is to the appropriate quality, on time and within budget

What we offer

Generous holiday allowance starting at 27 days plus bank holidays
A discretional annual performance related bonus
Private medical insurance packages
Employee Assistance Program
Pension Plan
Paid Parental Leave
Special discounts for employees, family, and friends
Access to learning and development resources

Fulltime

Aqd corporate reporting advisory senior manager

This is an opportunity for a talented, high performing and ambitious Senior Mana...

Location

United Kingdom , London; Greater Manchester; Leeds; Birmingham; Reading

Salary:

Not provided

BDO UK LLP

Expiration Date

Until further notice

Requirements

ACA/ICAS qualified or overseas equivalent
Senior Manager in a technical team or have other relevant experience in technical financial reporting
Strong working knowledge of IFRSs, UK GAAP, and the Companies Act
Sector specialism for financial services, particularly Banking and Alternative Finance, Fintech or Insurance
Knowledge of content requirements for the annual report of a company listed on either the Main Market or the AIM market of the London Stock Exchange
Knowledge of the wider financial reporting environment, including future developments in law, regulation and emerging areas
Practical experience of performing technical reviews of annual reports of listed companies
Proven ability to apply technical knowledge to complex financial reporting issues and provide practical and supportable solutions
Strong oral and written communication skills, and an ability to adapt as appropriate to the scenario
Ability to create productive relationships across the firm and network and to influence other senior professionals

Job Responsibility

Work with Managers, Senior Managers, Directors and Partners within both AQD, the Audit Stream and across the wider firm
Maintain and encourage an open and constructive environment in which to provide technical accounting support and advice
Bring pre-existing financial services specialist technical accounting knowledge and experience to the CRT team and contribute to all output areas
Provide support and supervision to the more junior team members
Technical review of a personal portfolio of annual reports of publicly traded and other higher risk companies
Providing clear and practical solutions to the most complex technical financial reporting queries, and act as a consultant for the more junior members of the team in your specialist area
Preparing and presenting financial reporting training, updates and seminars both internally and externally
Helping to develop financial reporting tools and guidance for application by the firm’s partners and staff
Writing articles and other publications on financial reporting matters for internal and external communications
Assisting with the preparation of draft responses to external consultations in relation to legal, regulatory and financial reporting matters

What we offer

Health and wellness programmes
Pension plan with matched employer contributions
Private medical access for you and your family
Income protection plan
Holiday purchase scheme (up to 10 additional days)
Bike to work scheme
Agile working
Wellbeing programmes
Career development programmes
Mentoring and coaching

Regulatory Writing Senior Manager

Amgen

Location:
United States

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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