6,547 Freelance Reviewer jobs in the United States

Actalent is Hiring a QA ReviewerJob Description
The position involves reviewing all analytical reports and raw and electronic data from CMC, including various materials and equipment calibration. The role requires informing the CMC Manager and QA when tests are not within specified limits to take appropriate actions.
Responsibilities
+ Ensure analytical data meets company standards and regulatory requirements.
+ Review test results and raw data for various materials and stability samples, including assays, chromatographic purity, content uniformity, particle size distribution, density, and water determination.
+ Check laboratory notebooks and associated documents for correctness and verify all reagents, standards, and equipment used.
+ Review raw data for audit trails and instrument logs on cGMP instrumentation and equipment.
+ Review validation and method optimization reports.
+ Ensure chemists follow SOPs and cGMP regulations and use correct methods for each product.
+ Promptly review notebooks and sign off on all analytical test results and reports.
+ Analyze and interpret results in written and oral formats.
+ Work with analysts for document corrections and provide guidance on laboratory notebook documentation requirements.
+ Follow SOPs and Safety Guidelines to ensure compliance with cGMP environment and Safety Practices.
+ Provide support during regulatory and internal audits.
+ Review Laboratory Incidents, OOS, OOT, and OOE investigations.
+ Perform additional tasks as assigned by the QA supervisor.
Essential Skills
+ Proficiency in chemistry and quality control.
+ Experience in data review and quality assurance.
+ Familiarity with LC, GC, CAPA, and Change Controls.
+ Bachelor's degree in Chemistry or related field.
+ 4+ years of related experience in pharmaceutical analysis.
Additional Skills & Qualifications
+ Experience with various analytical instrumentation, software, and tests performed in the lab, including HPLC, GC, Dissolution, Raw Materials, etc.
+ Understanding of SOPs, USP/NF procedures, and requirements.
+ Previous cGMP/regulatory experience is preferred.
Work Environment
This is an on-site role from Monday-Friday / both first and second shifts are available. The position generally involves standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. Occasionally, bending, kneeling, crouching, stooping, and crawling may be required.
Pay and Benefits
The pay range for this position is $32.00 - $35.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Fort Lauderdale,FL.
Application Deadline
This position is anticipated to close on Sep 5, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.

Job Description

Job Description

About Us:

VOALA Helping Our Most Vulnerable Change Their Life Stories

Volunteers of America is a non-profit human services organization committed to serving people in need, strengthening families, and building communities. VOALA provides a variety of social services to Los Angeles area communities such as Head Start programs, Upward Bound college prep programs, veterans’ services, homeless shelters, low-income housing program as well as drug and alcohol rehabilitation. Learn more at

PAY RATE: $24.84 - $26.15 Per Hour

BENEFITS: VOALA offers competitive medical, dental, vision and retirement benefits.

JOB SUMMARY AND PURPOSE

Under the direction of a Quality Assurance Coordinator, the Quality Assurance Reviewer I performs Quality Assurance review and audit of VOALA Program documentation and database practices related to grant, contract and legal requirements as well as organization policies and initiatives for assigned human services programs. The QA Department provides dedicated QA teams (Quality Assurance Reviewers and Quality Assurance Coordinators) to support VOALA Programs’ ability to be “audit ready.”

DUTIES AND RESPONSIBILITIES

• Conduct Quality Assurance procedures with their assigned VOALA Programs:
• Execute QA procedures to ensure that VOALA Program files are accurate and meet funder requirements (both hard copy and electronic databases)
• Performs QA audit for every assigned VOALA program each fiscal year
• Strives to have all assigned VOALA programs “audit ready” for external audits
• Acquire broad knowledge of assigned program contracts and grants and their requirements through research and continuous engagement with programs
• Perform special audits of programs with corrective action plans or as otherwise identified by Director of Evaluation and Monitoring. Provide additional support to programs to ensure corrections are made. Provide related training where needed.
• Support programs prior to funder audits and ensure all requirements are in place. Review audit results from funders’ audits. Participate in after audit review of audits.
• Other duties as may be assigned by Director of Evaluation and Monitoring.

ESSENTIAL DUTIES:

• Perform Quality Assurance (QA) in support of VOALA programs, ensure Program records and procedures meet funder requirements and are ready to pass funder audits.
• Stay current with assigned VOALA Program grants/contracts,
• Conduct special audits of Programs, as directed by Director of Evaluation and Monitoring; identify corrective action needed
• Support Programs prior to, during, and subsequent to funder audits; Participate in after audit reviews of all external audits.
• Other duties as required and is subject to change at any time.

Qualifications

REQUIREMENTS:

• Must be able to pass a fingerprint clearance, background check, including criminal history, personal references, employment and education verifications

EDUCATION:

• Bachelor’s Degree in social science or related field, or equivalent combination of education and related work experience (4 years)

EXPERIENCE:

• 1 year of experience in quality assurance or data driven environment
• (Five years of related work experience without a degree)

PREFERRED QUALIFICATIONS:

• Experience in data entry and database operations; familiarity with HMIS and/or Service Point
• Working knowledge of Medi-Cal regulations, especially relating to provision of substance abuse treatment

Volunteers of America is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

This employer participates in E-Verify as required by the federal government and will provide the federal government with your Form 1-9 information to confirm that you are authorized to work in the U.S.

If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (OHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment.

Job Description

Job Description

About Us:

VOALA
Helping Our Most Vulnerable Change Their Life Stories

Volunteers of America is a non-profit human services organization committed to serving people in need, strengthening families, and building communities. VOALA provides a variety of social services to Los Angeles area communities such as Head Start programs, Upward Bound college prep programs, veterans’ services, homeless shelters, low-income housing program as well as drug and alcohol rehabilitation. Learn more at

PAY RATE: $29.18 - $30.72 Per Hour

BENEFITS: VOALA offers competitive medical, dental, vision and retirement benefits.

JOB SUMMARY AND PURPOSE

Under the direction of a Quality Assurance Coordinator, the Quality Assurance Reviewer II performs Quality Assurance review and audit of VOALA Program documentation and database practices related to grant, contract and legal requirements as well as organization policies and initiatives for assigned human services programs. The QA Department provides dedicated QA teams (Quality Assurance Reviewers and Quality Assurance Coordinators) to support VOALA Programs’ ability to be “audit ready.”

DUTIES AND RESPONSIBILITIES

• Conduct Quality Assurance procedures with their assigned VOALA Programs:
  • Execute QA procedures to ensure that VOALA Program files are accurate and meet funder requirements (both hard copy and electronic databases)
  • Performs QA audit for every assigned VOALA program each fiscal year
  • Strives to have all assigned VOALA programs “audit ready” for external audits
• Acquire broad knowledge of assigned program contracts and grants and their requirements through research and continuous engagement with programs
• Perform special audits of programs with corrective action plans or as otherwise identified by Director of Evaluation and Monitoring. Provide additional support to programs to ensure corrections are made. Provide related training where needed.
  • Handles more complex programs as assigned by Quality Assurance Coordinator
  • Provides assistance to peers and HMIS specialists as needed
• Support programs prior to funder audits and ensure all requirements are in place. Review audit results from funders’ audits. Participate in after audit review of audits.
• Other duties as may be assigned by Director of Evaluation and Monitoring.

ESSENTIAL DUTIES:

• Perform Quality Assurance (QA) in support of VOALA programs, ensure Program records and procedures meet funder requirements and are ready to pass funder audits.
• Stay current with assigned VOALA Program grants/contracts,
• Conduct special audits of Programs, as directed by Director of Evaluation and Monitoring; identify corrective action needed
• Support Programs prior to, during, and subsequent to funder audits; Participate in after audit reviews of all external audits.
• Other duties as required and is subject to change at any time.

Qualifications

REQUIREMENTS:

• Must be able to pass a fingerprint clearance, background check, including criminal history, personal references, employment and education verifications

EDUCATION:

• Bachelor’s Degree in social science or related field, or equivalent combination of education and related work experience (4 years)

EXPERIENCE:

• 3 years of experience in quality assurance or data driven environment
• (Seven years of related work experience without a degree)

PREFERRED QUALIFICATIONS:

• Experience in data entry and database operations; familiarity with HMIS and/or Service Point

• Working knowledge of Medi-Cal regulations, especially relating to provision of substance abuse treatment

Volunteers of America is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

This employer participates in E-Verify as required by the federal government and will provide the federal government with your Form 1-9 information to confirm that you are authorized to work in the U.S.

If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact Department of Homeland Security (OHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment.

Job Description
Insight Global is looking for an Infrastructure Quality Assurance Reviewer to join a food & beverage client remotely in Mexico. Responsible for ensuring documentation accuracy and compliance across all phases of infrastructure delivery projects. This includes validating that required documents are complete, properly named, and stored according to project phase and internal standards. Conducts quality assurance reviews at key lifecycle milestonesinitiation, planning, execution, and closurewhile monitoring budget adherence and vendor payment timelines. Verifies that project trackers maintained by Program Managers are current and accurate. Enforces governance and quality standards, supports QA framework implementation, and collaborates with stakeholders to document and resolve issues. Assists in developing and refining delivery processes, templates, and quality control checkpoints. Engages with project teams to communicate QA findings and ensure follow-through, while providing leadership with regular reports and KPIs on project quality, vendor performance, and documentation compliance.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form ( . The EEOC "Know Your Rights" Poster is available here ( .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: .
Skills and Requirements
- 5+ years of experience in Quality Assurance or Project Delivery within IT Infrastructure or Technology environments.
- Strong understanding of project documentation standards, governance frameworks, and risk/control principles.
- Strong interpersonal and communication skills; able to collaborate effectively across teams. Fluent in English (spoken and written)
- Experience with SharePoint, ServiceNow, and Microsoft Office Suite (Excel, PowerPoint, Outlook).
- Knowledge of ITIL, ITASM (IT Asset and Service Management) - Knowledge of Waterfall and Agile methodologies null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to

Description:

• Medical Review for label, clinical data and disease state
• Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews
• Aligns medical education and scientific initiatives with Scientific Communication Platform
• The Med Reviewer has a key role within the designated Therapeutic Area.
• Working under the leadership of the Scientific Director/Medical Director, this leader supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic and operational input into core medical affairs activities including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation
• This leader ensures tactical execution is relevant to the market- physicians, patients and payors.
• With oversight, contributes to the development of the therapeutic area strategy.
• Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with the indication or asset's strategic plan.
• Leads conference planning and execution.
• Represents at external meetings including investigator meetings, scientific association meetings, etc.
• May be responsible for Medical Review (MR) training for on label, clinical data and disease state.
• Responsible for managing budget for assigned projects including consulting and vendor management.
• Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication
• Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews.
• Aligns medical education and scientific initiatives with the Scientific Communication Platform.
• Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
• Contributes to all launch readiness reviews/planning.

Qualifications:

• Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
• 3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment.
• Substantial understanding of relevant therapeutic area required.
• Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Good understanding of Medical Affairs principles, study design and publications.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
• Ability to interact externally and internally to support global business strategy.
• Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills.
• Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
• Ability to work effectively in a team/matrix environment.
• Ability to influence others without direct reporting relationships.
• Ability to work independently, with the potential to quickly onboard, because candidate has
• Previous experience performing medical review of both medical and promotional materials
• Previous experience reviewing in Veeva PromoMats and/or MedComms (CRM knowledge)
• Previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new
• Oncology background is a plus

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Job Description:
The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients.
Activities:

• Assisting with ongoing continuous improvement projects spanning across departmental needs.
• Responsible for individual and periodic medical device safety reporting.
• Responsible for PI site notifications.
• Providing support for training and automation efforts.
• Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed.
• Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.
• Biomedical engineer or RN Required.
• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day).

Responsibilities:

• Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies.
• Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and Client community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
• Off-label information would be disseminated at this level.
• May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification.

Requirements:

• Bachelor's degree in nursing required or higher with minimum 3-4 years' experience in the medical device industry required.
• Minimum 5 years direct patient care as a Registered Nurse preferred.
• Expert level of understanding of global Medical Device regulations such as FDA, EU-MDR and other guidelines affecting device safety issues.
• Sound understanding and application of device risk management and associated risk management documents such as Clinical Hazards List, Application Failure Mode and Effects Analysis, System Risk Analysis etc.
• Excellent critical thinking and application skills required.
• Ability to speak up and support medical device safety analytics team in meetings and explain position of the clinical team.
• Able to apply clinical knowledge and expertise to adverse event data and perform safety assessment.
• Competent in ability to present device safety event data, orally and in writing.
• Adheres to policies and regulations.
• Must be Computer proficient (Windows, Word, Excel).

Job Description

Pay range: 34-44/hr
*depending on experience

Description:

The primary responsibilities would include
• Medical Review for label, clinical data and disease state
• Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews
• Aligns medical education and scientific initiatives with Scientific Communication Platform

What are the top 3-5 skills, experience or education required for this position (in order of priority):
1. Ability to work independently, with the potential to quickly onboard, because candidate has.
a. .previous experience performing medical review of both medical and promotional materials
b. .previous experience reviewing in Veeva PromoMats and/or MedComms (CRM knowledge)
c. .previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new disease states.
2. Ability to share concisely and clearly the rational for review decisions with broader Commercial and Medical Teams

Purpose
The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific Director/Medical Director, this leader supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic and operational input into core medical affairs activities including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation, this leader ensures tactical execution is relevant to the market- physicians, patients and payors.
Responsibilities
1. With oversight, contributes to the development of the therapeutic area strategy.
2. Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with the indication or asset's strategic plan.
3. Leads conference planning and execution. Represents at external meetings including investigator meetings, scientific association meetings, etc.
4. May be responsible for Medical Review (MR) training for on label, clinical data and disease state.
5. Responsible for managing budget for assigned projects including consulting and vendor management.
6. Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication
7. Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews.
8. Aligns medical education and scientific initiatives with the Scientific Communication Platform.
9. Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
10. Contributes to all launch readiness reviews/planning.

Qualifications - External
1. Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
2. 3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required.
3. Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
4. Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
5. Good understanding of Medical Affairs principles, study design and publications.
6. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
7. Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
8. Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills.
9. Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
10. Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

Job Description:
The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific Director/Medical Director, this leader supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic and operational input into core medical affairs activities including thought leader engagement plans and field provider interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives and promotional material generation, this leader ensures tactical execution is relevant to the market- physicians, patients and payors.
Responsibilities:

• With oversight, contributes to the development of the therapeutic area strategy.
• Contributes to the development of and leads the execution of the medical education tactics, advisory boards, and thought leader engagement plan in line with the indication or asset's strategic plan.
• Leads conference planning and execution. Represents Client at external meetings including investigator meetings, scientific association meetings, etc.
• May be responsible for Medical Review (MR) training for on label, clinical data and disease state.
• Responsible for managing budget for assigned projects including consulting and vendor management.
• Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication.
• Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews.
• Aligns medical education and scientific initiatives with the Scientific Communication Platform.
• Contributes to the generation of Medical Information (MI) communication content and supports training on MI materials.
• Contributes to all launch readiness reviews/planning.

Requirements:

• Advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
• 3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment.
• Substantial understanding of relevant therapeutic area required.
• Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIP nd patient privacy laws, EU Directive and other applicable local regulations.
• Good understanding of Medical Affairs principles, study design and publications.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
• Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
• Ability to interact externally and internally to support global business strategy.
• Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills.
• Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
• Ability to work effectively in a team/matrix environment.
• Ability to influence others without direct reporting relationships.

Top Skills:

• previous experience performing medical review of both medical and promotional materials.
• previous experience reviewing in Veeva Promo Mats and/or Med Comms (CRM knowledge).
• previous experience in AML or various therapeutic areas with a proven ability to rapidly comprehend and excel in mastering new disease states.
• Ability to share concisely and clearly the rational for review decisions with broader Commercial and Medical Teams.

**Do you want your voice heard and your actions to count?**
Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world's leading financial groups. Across the globe, we're 120,000 colleagues, striving to make a difference for every client, organization, and community we serve. We stand for our values, building long-term relationships, serving society, and fostering shared and sustainable growth for a better world.
With a vision to be the world's most trusted financial group, it's part of our culture to put people first, listen to new and diverse ideas and collaborate toward greater innovation, speed and agility. This means investing in talent, technologies, and tools that empower you to own your career.
Join MUFG, where being inspired is expected and making a meaningful impact is rewarded.
The selected colleague will work at an MUFG office or client sites four days per week and work remotely one day. A member of our recruitment team will provide more details.
The Americas Global Financial Crimes Division (GFCD) Quality Assurance (QA) team organizationally resides within the Global Financial Crimes Compliance (FCC) Program Management department. GFCD works to ensure that our organization conducts its business such that we protect our reputation, our business, and our clients within the regulatory and legal framework. It is responsible for the establishment and maintenance of effective systems and controls to protect clients' assets and to mitigate the risk that MUFG might be used to further financial crime.
GFCD QA is responsible for driving QA standardization and consistency in both the first and second lines of defense through setting minimum QA standards, providing technical advisory, discharging oversight and governance, and building an effective QA execution capability.
The individual will be responsible for carrying out QA reviews over key financial crimes controls (AML and Sanctions) in the Regional Americas GFCD QA Execution function. As Americas GFCD Senior QA Reviewer, you will contribute to the operation of the financial crime compliance framework. Thus, your responsibilities and accountabilities include, but are not limited to, supporting the implementation of the QA program in a "business as usual" environment to mitigate the financial crime risks. The Americas GFCD Senior QA Reviewer role reports directly into the Americas GFCD QA Execution Lead.
**Qualifications**
+ Executing QA reviews in accordance with the QA operating manuals.
+ Executing quality control (QC) over the QA reviews in accordance with the QA operating manuals.
+ Supporting the drafting, refreshing, and maintaining the Americas GFCD QA Execution components of the Americas GFCD QA operating manual.
+ Supporting the drafting, refreshing, and maintaining the Americas GFCD QA Execution annual plan.
+ QA execution and supporting the deployment over regional GFCD-owned FC controls to QA functions across the region.
+ Supporting the implementation of a coordinated, consistent, and risk-based AML and Sanctions QA program.
+ Communication of the results of the QA reviews relating to financial crimes controls to the appropriate parties and are addressed in a timely manner.
+ Supporting the planning, designing, scoping, executing, escalating, and reporting QA reviews as a part of the overall QA cycle in accordance with the Global FCC QA Methodology.
+ Delivery of the work assigned to the role holder, including meeting target dates and deadlines.
+ Quality of the work assigned to the role holder, including the completeness and accuracy of the work.
+ Escalating identified risks or issues to the Americas GFCD QA Execution Lead in a timely manner.
+ Completing actions on time where the role holder is the action owner.
+ Completing mandatory training on time.
+ Achieving annual personal objectives or escalating risks to achieving the annual personal objectives to the Americas GFCD QA Execution Lead in a timely manner.
+ Maintaining technical and non-technical personal development to meet the demands of the role.
+ The role holder will be a role model through leading by example and may need to support more junior members through coaching and mentoring.
**Experience**
+ 3-5 years of experience working within a Financial Crimes Compliance Quality Assurance role
+ Operating ABC, AML, and/or Sanctions control processes.
+ Experience interacting with compliance subject matter experts.
+ Moderate financial industry and compliance experience, preferably within a global organization in a role directly involved with operational activities
+ Knowledge of: QA concepts, including sampling, stratification, QA testing, and QA MI.
+ Proven excellence in execution in complex and demanding situations.
+ Collaborative with strong interpersonal communication skills.
+ Process oriented couple with a strong ability to develop appropriate program enhancing strategies.
+ Detail-oriented and organized execution.
+ Good presentation skills.
+ Demonstrated ability to manage multiple projects simultaneously.
**Education**
+ Financial crimes risk management or control design and evaluation related certifications.
The typical base pay range for this role is between $90k-$112k depending on job-related knowledge, skills, experience and location. This role may also be eligible for certain discretionary performance-based bonus and/or incentive compensation. Additionally, our Total Rewards program provides colleagues with a competitive benefits package (in accordance with the eligibility requirements and respective terms of each) that includes comprehensive health and wellness benefits, retirement plans, educational assistance and training programs, income replacement for qualified employees with disabilities, paid maternity and parental bonding leave, and paid vacation, sick days, and holidays. For more information on our Total Rewards package, please click the link below.
MUFG Benefits Summar ( y
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws (including (i) the San Francisco Fair Chance Ordinance, (ii) the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, (iii) the Los Angeles County Fair Chance Ordinance, and (iv) the California Fair Chance Act) to the extent that (a) an applicant is not subject to a statutory disqualification pursuant to Section 3(a)(39) of the Securities and Exchange Act of 1934 or Section 8a(2) or 8a(3) of the Commodity Exchange Act, and (b) they do not conflict with the background screening requirements of the Financial Industry Regulatory Authority (FINRA) and the National Futures Association (NFA). The major responsibilities listed above are the material job duties of this role for which the Company reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of conditional offer of employment, if any.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of personnel so classified.
We are proud to be an Equal Opportunity Employer and committed to leveraging the diverse backgrounds, perspectives and experience of our workforce to create opportunities for our colleagues and our business. We do not discriminate on the basis of race, color, national origin, religion, gender expression, gender identity, sex, age, ancestry, marital status, protected veteran and military status, disability, medical condition, sexual orientation, genetic information, or any other status of an individual or that individual's associates or relatives that is protected under applicable federal, state, or local law.
At MUFG, our colleagues are our greatest assets. Our Culture Principles provide a roadmap for how each of our colleagues must think and act to become more client-obsessed, inclusive and innovative. They reflect who we are, who we want to be and what we expect from one another. We are excited to see you take the next step in exploring a career with us and encourage you to spend more time reviewing them!
**Our Culture Principles**
+ Client Centric
+ People Focused
+ Listen Up. Speak Up.
+ Innovate & Simplify
+ Own & Execute