Senior Manager Informed Consent 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

New

Senior Manager Informed Consent

Shape how patients around the world understand and engage with clinical research...

Location

United Kingdom , Uxbridge; London; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Clinical trial execution experience
Previous people leadership managing teams, projects, or resources
Previous experience in life sciences including managing data on biopharmaceutical clinical research experience
Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)
Experience in roles that include patient centricity and/or Informed Consent Development and oversight

Job Responsibility

Lead and develop a high-performing global Informed Consent Form (ICF) team
Own the end-to-end ICF development process, driving continuous improvement in quality, speed, and standardisation
Provide strategic and operational leadership for ICF planning, resourcing, and execution across the pipeline
Ensure compliance with global and country-specific regulatory requirements and inspection readiness
Partner cross-functionally to deliver patient-centric, clear, and consistent informed consent content
Monitor performance metrics, trends, and inspection findings to drive data-led improvements
Act as a change leader, strengthening collaboration, accountability, and clarity of roles across stakeholders
Line manage and mentor ICF managers, building capability, engagement, and a culture of excellence

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Compliance Analyst

insightsoftware is seeking a detail-oriented and proactive Compliance Analyst to...

Location

United States , Remote

Salary:

Not provided

insightsoftware

Expiration Date

Until further notice

Requirements

Bachelor's degree in information security, Cybersecurity, Computer Science, Risk Management, Legal Studies, Business Administration, or related field
Minimum 3+ years of experience in compliance program management, risk management, or information security roles, preferably in regulated industries or technology companies
Demonstrated experience responding to third-party risk assessments, security audits, customer security questionnaires, RFPs, and compliance due diligence requests
Working knowledge of regulatory frameworks and standards (e.g., ISO 27001, SOC 2 (Type II), NIST, FedRAMP, CMMC, PCI DSS, GDPR, CCPA), trade control regulations (EAR, ITAR), anti-bribery/corruption laws (FCPA, UK Bribery Act), and data privacy principles
A strong knowledge of at least one regulatory framework governing matters pertaining to data privacy, cybersecurity, trade compliance, or third-party risk management
Experience with third-party screening tools and vendor risk management platforms
Familiarity with GRC or data protection management platforms (e.g., OneTrust, ServiceNowMetricStream)

Job Responsibility

Support the development, implementation, and maintenance of a global compliance program, including trade compliance, anti-bribery/corruption, anti-trust, and business ethics
Conduct secondary screening of third parties (vendors, partners, customers) , and assess potential matches against government watchlists of denied, debarred, sanctioned, or restricted parties to ensure compliance with applicable trade compliance, export control and sanctions regulations (e.g., U.S. Department of the Treasury Office of Foreign Assets Control ("OFAC"), U.S. Department of Commerce Bureau of Industry and Security ("BIS"), U.K. Office of Financial Sanctions Implementation ("OFSI"), European Union, and United Nations)
Assist with export classification determinations and licensing requirements for software products and services, including evaluation of Export Control Classification Numbers ("ECCNs")
Support the company's compliance with applicable data protection regulatory frameworks (e.g., GDPR, CCPA)
Support the Corporate Counsel, Data Privacy, AI, Cybersecurity with data protection initiatives and obligations including data mapping exercises, processing activity records, and privacy impact assessments, and coordinate responses to data subject access requests ("DSARs") and privacy-related inquiries
Support privacy management tools and platforms for consent management and privacy workflow automation
Partner with company counsel, InfoSec, and other stakeholders with compliance audits, data privacy questionnaires, and third-party risk assessment processes including vendor due diligence and ongoing monitoring
Support risk and control self-assessments ("RCSA"), audit management, and remediation tracking
Collaborate with stakeholders including the Chief Information Security Officer ("CISO") and the team to quantify, monitor, and report on security and compliance performance
Maintain GRC platforms (e.g., ServiceNow, Archer, MetricStream) to track compliance activities, risks, and controls

Oncology Research Nursing Professional

The Oncology Research Nursing Professional (ORNP) –is a Registered Nurse (RN) wh...

Location

United States of America , Palo Alto

Salary:

83.98 - 111.27 USD / Hour

Stanford Health Care

Expiration Date

Until further notice

Requirements

BSN or higher-level nursing degree required
5 plus years nursing experience required OR 3+ years in an oncology research nurse role required
2 or more years of experience in oncology
California Registered Nurse (RN) license
American Heart Association Basic Life Support (BLS) certification
Ability to communicate vetted information at all levels of the organization
Ability to be highly- and multi- task focused while managing multiple tasks and projects simultaneously across various platforms
Ability to understand information flow and solve problems under pressure
Ability to manage conflict resolution
Ability to adapt and troubleshoot in a unique and quickly changing, fast-paced environment

Job Responsibility

Collaborates with the investigator and serves as lead on study patient screening, eligibility determination and enrollment assessments on assigned clinical trials
Uses independent judgement to assess, identify, and prioritize clinical information to physician, NP, PA and other clinicians for patients who are being evaluated and/or enrolled in a clinical trial
Assesses and documents signs and symptoms of illness, reactions to treatment, changes in physical or psychological condition and general appearance in accordance with the research protocol
Manage patient/family phone calls – collaborating with MD, NP and/or PA as needed to obtain orders for the management of the patient
Manages and communicates all aspects of care as defined by the research protocol with the physician and other health care professionals and research team members
Collaborates with CRC to assure that therapeutic clinical trial flag is placed on the patient during active treatment
Plans, coordinates, and completes randomization (if applicable), patient assessments (toxicity assessment, diagnostic tests, and questionnaires), treatments and follow up care according to the defined protocol treatment plan
Manages the consent process to ensure it is performed in compliance with institutional, FDA, IRB, clinical trial sponsor and other applicable regulations
Oversees and participates in the education of the patient regarding the clinical trial
Alerts principal investigator of any concerns raised by the patient during the informed consent process

Fulltime

Associate Director, Contracts

We are seeking an experienced biotech industry contract specialist to provide ge...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree, or an equivalent amount of relevant industry experience in a legal or related field, is required
6+ years of experience in the life sciences industry drafting and negotiating a variety of contracts
Public company experience required
Prior in-house experience as a member of a Legal Department or clinical affairs department in a biotechnology or pharmaceutical company drafting and negotiating clinical trial agreements strongly preferred
Experience with confidentiality agreements, master services agreements, consulting agreements, clinical trial agreements, GCP guidelines and regulatory requirements for global clinical trials
Exceptional contract drafting and negotiation skills
Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization
Excellent professionalism and interpersonal skills
ability to handle confidential and proprietary information using sound judgement and discretion
Experience with contract management systems and electronic signature systems and high proficiency in Microsoft Office applications required

Job Responsibility

Partner with Legal Department members to assist with the drafting, negotiation and management of a high volume of contracts for clinical, research, quality, manufacturing, commercial and other internal business partners, including clinical trial agreements, master services agreements, consulting agreements, confidentiality agreements, research agreements and other business agreements
Act as a liaison between internal business partners, the Legal Department, external vendors and outside counsel as necessary to facilitate contract implementation, renewals, and terminations
Continue to improve the internal contracting process, including assisting with the administration of our integrated contracts management system, developing internal training materials related to the contracting process and identifying steps to increase efficiency
Help develop and implement new policies, procedures and contract templates and provide related education and training to internal clients
Work closely with members of finance and other departments to help ensure compliance with cross-functional policies and procedures
Develop reports, presentations, spreadsheets, memos and other documents for the Legal Department, internal clients and/or the senior management team
Review clinical study informed consent forms and related documents as needed
Assist with completion, review and validation of needs assessment forms in connection with HCP engagements, including to confirm alignment with fair market value and contractual terms
Identify legal, documentation gaps and contractual risks and escalate matters in accordance with protocols and guidance
Provide practical contracts support to internal clients during contract preparation and negotiation

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Senior Clinical Research Coordinator

The Computational Health Informatics Program (CHIP) is seeking an experienced, h...

Location

United States , Boston

Salary:

58676.80 - 93901.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree
Master’s preferred
Bachelor’s degree and 4 years of relevant work experience OR Master’s degree and 2 years of relevant work experience
Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex
Well-developed communication skills to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions
Ability to effectively engage with and influence others
build working relationships and can work independently and as a team member, leads others when needed
Act as a resource and must be knowledgeable and compliant in all hospital, State, and Federal regulatory requirements, including hospital policy and procedures

Job Responsibility

In conjunction with the Principal Investigator and/or designees designs, develops, and implement clinical research projects such as enrollment strategies, study materials, and study documents
Responsible for daily operations of the study
Develops and implements processes and procedures to meet study goals and protocol requirements
Participate in training and prepare study related training materials
Plans and prioritizes the work of administrative and support personnel on all clinical study activities
Consents and enrolls patients for research studies by providing detailed information on the Clinical Study to patients and families
Communicates all policies and procedures and responds to all inquiries
Evaluate the suitability of prospective study candidates and make selections based on clinical knowledge of each study
Provide input for updates of SOPs and drafting of new quality documentation
Assist with developing and implementing best practice guidelines for conducting various clinical research protocols

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Program / Project Manager (PMO)

It is the intent of this document to outline a general description of the Scope ...

Location

United States , Minneapolis

Salary:

Not provided

Dash Technologies

Expiration Date

Until further notice

Requirements

planning
Program and Project Leadership Experience in leading discovery, and delivery of IT initiatives aligned with enterprise strategy, regulatory requirements, organizational priorities, and community impact
Stakeholder and Change Management Operate effectively in evolving problem spaces by synthesizing information from multiple sources, identifying patterns and tradeoffs, and driving toward clear decisions and next steps through a hands-on, “lead by doing” approach
Performance and Value Management Establish feedback loops across projects to learn quickly, adapt approaches, and apply lessons learned across the broader program

Job Responsibility

Leads complex, multi-department technology initiatives that strengthen accountability, transparency, and service delivery across the City of Minneapolis—particularly in support of public safety transformation and the City’s compliance with the Minnesota Department of Human Rights (MDHR) settlement agreement and the Department of Justice (DOJ) consent decree
Partner with a Senior IT Program manager to create and manage program and project plans that include clear outcomes, success metrics, budgets, schedules, and risk management strategies
Manage interdependent projects within a broader program framework, ensuring alignment, coordination, and shared accountability
Maintain a tracking mechanism to ensure IT investments and projects meet or exceed customer expectations
Develop business-centric enterprise information management solutions, derived from an assessment of business practices, culture, products, customers and objectives that meet the needs of operating units
Deliver IT solutions integrated into the Enterprise infrastructure and combine appropriate enabling technology, existing IT applications/infrastructure and commercial off-the-shelf products into proposed IT solutions
Operate effectively in evolving problem spaces by synthesizing information from multiple sources, identifying patterns and tradeoffs, and driving toward clear decisions and next steps through a hands-on, “lead by doing” approach

Fulltime

Clinical Research Coordinator II-OB/GYN

Under minimal supervision, coordinates the clinical assessments of the study sub...

Location

United States , New York

Salary:

63653.84 - 85000.06 USD / Year

Mount Sinai Health System

Expiration Date

Until further notice

Requirements

Bachelors degree in sciences or related field
2 years of clinical research

Job Responsibility

Analyzes moderately complex clinical research data
Assists in interpreting clinical research data
Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects
Prepares and ensures grant applications, IRB/GCO documents are submitted
Ensures accurate and complete compilation of subject data through chart reviews
Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Obtains informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests
Independently obtains informed consent for other clinical studies
Mentors Clinical Research Coordinators in training
Performs other related duties

Senior Manager Informed Consent

Amgen

Location:
United States

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 20, 2026

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