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Compliance Officer Job at Xelay Acumen

Xelay Acumen San Mateo, CA 94401

Job Description: Compliance Officer

About Xelay Acumen

Xelay Acumen, Inc was founded in 2012 and is the premier strategy and management
consulting firm serving biotechnology, pharmaceutical, and health care provider clients. Our
engagements focus exclusively on high value-add for our clients’ most critically important
issues and challenges.

At Xelay Acumen, Inc., our people are excited to help clients address their most pressing
issues and challenges. We leverage the flexibility and expertise of our diverse network and
organization and bring to bear an unparalleled combination of skill sets: strategic problem
solving, rigorous analyses and methodologies, and clear and concise communications to bring
about uniquely extraordinary results.

Responsibilities

The Compliance Officer role is a full-time position to support and advise on legal and
regulatory matters within the biotechnology, pharmaceutical, and health care provider industry,
and collaborate with client and team members to accomplish project engagement goals and
objectives. Responsibilities include:

1. Compliance - Develop and Monitor Processes and Regulations: 60% of time
  • Publications
  • Processes for Compliant Operations
  • Executive Decision Making
  • Team Development

2. Clinical Patient Trial Data Analyses - Plan and Conduct Clinical and Statistical
Analyses: 10% of time

3. Medical Writing - Create Scientific Reports and Publications: 20% of time
4. Administration and Management - Involve with Cross-Functional Teams: 10%

of time

Desired Qualifications

  • Degree requirements: Bachelor’s or master’s in health administration
  • Deep understanding of HIPAA and OSHA regulations
  • Experience in consulting firm and healthcare industry
  • Strong analytical and problem-solving skills and the ability to conduct complex data

analysis using analytical databases/tools, including Microsoft Excel (eg, pivot tables,
LOOKUP, SUMIF, COUNTIF functions, etc)

  • Extensive experience with PowerPoint presentations in consulting or banking
  • Excellent communication skills, both written and verbal
  • Ability to work well in teams
  • Strong desire and openness to learning and trying unconventional approaches
  • Ability to relocate to the SF-Bay area

Interested parties should send resume to Jobs@XelayAcumen.com

For more information, visit: www.xelayacumen.com or find us on LinkedIn and Facebook.


Detailed Job Description

OUR PEOPLE

Xelay Acumen Compliance Officers are a diverse group of highly qualified people with a wide
range of backgrounds, from life sciences to business to medicine. Offering challenging and
management responsibilities, broad business exposure and unrivaled career prospects, Xelay
Acumen’s Compliance Officer role provides an unparalleled opportunity to apply knowledge,
business intuition, and analytical rigor to real-world challenges, building invaluable skills and
experience along the way. Compliance Officers are MHA students, advanced degree (MD, JD,
PhD, PharmD) candidates and professionals with consulting experience. It's a great way to set
yourself up for future success—at Xelay Acumen and beyond. Compliance Officers leverage
their extensive backgrounds and expertise coupled with the Xelay Acumen training in
leadership, consulting, and management to develop powerful insights and drive results for our
clients. We invest heavily in our people and believe in the apprenticeship model of
management consulting.

Responsibilities may include

1. Compliance - Develop and Monitor Processes and Regulations:
1. Publications:

  • Develop and execute risk assessments and reviews of compliance risk areas
to determine need for improvement, often in consultation and coordination
with internal and external authors
  • Assist with healthcare compliance and policy regulation analysis reporting on
publication, medical information, and healthcare interaction to ensure
products and deliverables are conducted in a compliant manner with industry
standards and regulations

2. Processes for Compliant Operations:
• Under guidance, administer the policies and procedures for the company to

ensure compliance with extensive HIPAA (Health Insurance Portability and
Accountability Act) and OSHA (Occupational Safety and Health
Administration) regulations

  • Continually assist the company in monitoring the products, operations, and
programs to instantly initiate required changes when needed to assure
compliance
  • Research and gather appropriate information and documentation to conduct
company audits with accuracy and efficiency and analyze audit findings
against applicable health compliance standards, federal/state/local laws and
statutes, and company’s policies
  • Initiate and monitor new or revised procedures, including pricing, logistics,
and reimbursement changes within appropriate time frames that follow all
established healthcare regulations

3. Executive Decision Making: Comply with federal, state, and local legal
requirements by studying existing and new legislation; enforcing adherence to
requirements; advising management on needed actions

4. Team Development:
• Develop and train all the internal staff in compliance risk areas of publications

to ensure highest possible level of compliance
  • Develop evaluation metrics to measure the effectiveness of training and

evaluate employee’s performance

2. Clinical Patient Trial Data Analyses - Plan and Conduct Clinical and Statistical
Analyses:
• Assist in data organization
  • Conduct analyses using SQL, STATA, and Excel to evaluate drug’s efficacy and
safety
  • Decide final interpretation of the data in conjunction with other senior
researchers, medical scientists, and management
  • Modify statistical programs to analyze, review, or summarize data


3. Medical Writing - Create Scientific Reports and Publications:

  • Prepares statistical reports, tabulations, and graphs for presentation at meetings
or conferences, and for publication in the journals
  • Plan the number and type of publications (Abstract, Poster, and Manuscript) to
be submitted to the conferences and journals
  • Develop content such as slide kit, abstract, poster, and manuscript for a variety
of clinically oriented products for pharmaceutical clients
  • Ensure writing is of high scientific and literary standards to meet client’s
objectives

4. Administration and Management - Involve with Cross-Functional Teams:
• Perform medical and scientific benchmarking such as providing analogous

examples and explanations using non-technical terminology, and helping
researchers formulate and clarify research issues

  • Consult with medical and clinical Key Opinion Leaders and healthcare
administrators to receive their expert opinion on clinical trial data analyses, new
analyses to conduct, and improving messaging
  • Serve on the senior healthcare management and administration team and
participate in corporate level strategic planning

Time requirements: Full-Time




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