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About PharmaEssentia:

It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together.

PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung.

Position Overview:

The primary responsibility of a Medical Science Liaison (MSL) is the exchange of medical information with health care professionals (HCPs) involved with the management of myeloproliferative neoplasms (MPNs). As a key member of the Medical Affairs Team, you will facilitate and develop the relationship with the medical/scientific community including physicians and medical centers, by communicating product-related information to investigators and institutions. In addition, you will provide information on research developments, new clinical trials and new concepts in medical treatment, to bring our flagship product to market for the treatment of polycythemia vera (PV).

Key Responsibilities:

• Establish a respectable PharmaEssentia presence in the medical community.
• Identify and develop relationships with the medical community, thought leaders, and treatment advocates.
• Liaise and support the development of key and regional opinion leaders within a broad customer segmentation (community clinics, integrated delivery networks (IDNs), academic centers, etc.).
• Provide high quality medical and scientific support/communications to internal and external customers (e.g., advisory board meetings, regional training courses/workshops together with KOL/ROL, support of speakers with presentations and literature research)
• Lead medical education (disease statement, guidelines, and product information upon FDA approval).
• Manage studies and ensure that proposals are aligned with medical objectives within PharmaEssentia locally and globally. Ensure study projects are in line with commercial objectives.
• Maintain a high level of scientific and technical expertise in hematology, oncology, and blood disorders. Develop and increase knowledge of medical literature. Prepare and present critical reviews of scientific publications and congresses, internally and externally.
• Complete necessary documentation in order to ensure knowledge preservation (e.g., CRM reports). Utilize the necessary tools to develop and follow up on strategic measures (project plans).
• Write and ensure timely submission of locally relevant abstracts at congresses.
• Provide cross-functional support for Market Access and other Medical Affairs activities.
• Monitor competitor activities and marketplace changes.

Qualifications and Experience:

• Advanced Degree Required (PhD, PharmD, or MD)
• Experience in the pharmaceutical industry, including 3+ years in a field medical/MSL role
• Broad knowledge of general medicine with a focus in hematology, oncology or interferons.
• Knowledge in planning and execution of scientific studies and clinical trials
• Ability to develop and maintain relationships with key thought-leaders.
• Ability to introduce the disease state to the KOL community and articulate complex programs.
• Development of product knowledge and knowledge of Company and science
• Excellent writing and oral communication skills (including presentations)
• Strong networking skills (includes internal teams)
• On-time completion of goals with high-quality results
• Project planning and execution
• Quality of judgment and decision making
• Initiative on addressing issues for the team (“roll up your sleeves attitude”)
• Ability to maintain collaborative relationships within a dynamic team environment.
• Adherence and compliance with all required regulatory and GCP guidelines.

This is a remote role. The hired candidate must reside in the designated territory (MI, IN, OH, or KY).

The expected base salary range for this position is $165,240-238,680. Salary offers are based on a wide range of factors including relevant skills, training, experience, education and geographical location. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible for short-term and long-term incentives.

Benefits of working with our team:

PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $150 monthly cell phone reimbursement
• Employee Assistance Program
• Free parking

EEO Statement:

At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.

PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.

At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.

https://us.pharmaessentia.com/careers/

We’re expanding our capabilities across Latin America, and we’re hiring a Senior Clinical Research Associate to support critical studies across Brazil!

As a Senior CRA you’ll posses a wide-ranging and broad experience handling our most complex and advanced assignments. Responsibilities will be dependent upon the type and timing of the program to which the Senior CRA is assigned and will, at a minimum, include start-up and study implementation activities, on-site monitoring of clinical research studies as well as on-going site management. Incumbents are expected to be able to manage appropriately sized or complex clinical trials, and support Clinical Trial Managers and/or Project Managers with trials as required. An increased focus on training and mentoring junior staff members may be expected.

Responsibilities:

• Independently oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports
• Manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager
• If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Performs Monitoring Oversight Visits to assess other CRA team members. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote)
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Communicates effectively and proactively with both site personnel and Precision’s Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues
• Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision’s high quality and professional image
• Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
• Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies
• Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process
• Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with oversight from project team
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. May prepare or assist in preparation of study-specific presentations/training materials and tools
• Assists the team managers in the preparation and review of protocols and other study documentation
• Supports the design and development of CRFs and clinical trial documents as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.)
• Assists with review of clinical study reports
• Functions as a mentor, assisting with the training and developing of new employees and junior monitors
• Interacts with client, participates in proposal activities, including development and client presentations
• Initiates payment requests for investigators
• Travels as necessary according to project needs
• Other job duties as assigned

Minimum Education & Experience:

• 4-year college degree or equivalent experience in a scientific or healthcare discipline
• 5 years or more as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Significant site management experience or equivalent experience in clinical research
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Preferred Education & Experience:

• Graduate, postgraduate degree
• Experience monitoring in rare and complex therapeutic areas
• Experience monitoring EDC trials and EHR records
• Experience in biopharma or relevant therapeutic area
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the country
• Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
• Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Can assist junior CRAs in problem resolution
• Ability to travel overnight. Up to 60% travel on average, based on regional requirements. International travel as needed
• Select opportunities require Oncology experience preferably in early phases
• Exhibits self-motivation and is able to work and plan independently as well as in a team environment.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Demonstrated ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Demonstrated focus on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.

#LI-AG2 #LI-REMOTE

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.

It's fun to work in a company where people truly BELIEVE in what they're doing!

The range for this role is $31.97 per hour to $43.51 per hour

Actual base pay will be determined based on a successful candidate’s work location, skills/abilities, experience, and education.

Interested applicants must be willing and able to work onsite minimum 4 times per week in either our Melbourne, FL or Orlando, FL office.

The Mission

At Christian Care Ministry we believe that Christians can, and should, share in one another’s burdens. Through the use of Medi-Share®, a healthcare sharing ministry for Christians, we cultivate that belief. To that end, our Mission Statement is as follows: Connecting people to a Christ-centered community wellness experience based on faith, prayer, and personal responsibility.

The Team

Everyone at Christian Care Ministry is in agreement with our Statement of Faith, which outlines our core beliefs. Although we aren’t perfect people, we are serving our perfect God and our Members to the best of our ability.

The Job

The Senior Clinical Reviewer works to summarize and correlate concise, accurate information on medical reviews to determine eligibility of medical bills per the program guidelines. In this role, 70% of the time is spent performing pre-service and post-service medical reviews and/or reviews for high dollar, complex medical cases and collaborating with other departments to optimize cost savings.  This position leverages AI-enabled clinical review tools and electronically ingested data (278 transactions) to enhance the accuracy, efficiency, and consistency of medical reviews.  The Senior Clinical Reviewer will be expected to make decisions regarding timing and omission of medical reviews in deference to other department processes based on the dollar amount of the bill and the Ministry’s cost strategy.

Essential Job Duties & Responsibilities

• Organize and review medical records, lab results, radiology, and pathology reports for conditions ineligible for sharing (CIF’s)
• Determine eligibility of members’ medical bills and/or upcoming procedures/treatments according to the program guidelines
• Perform pre-service and post-service medical reviews utilizing AI-enabled clinical review tools to make evidence-based, consistent, and efficient determinations of sharing eligibility
• Review and interpret pre-service eligibility data (via 278 EDI transactions) to support streamlined medical review workflows
• Integrate structured electronic data with clinical documentation to support accurate and timely eligibility determinations
• Collaborate with other departments to maximize cost savings for individual cases and optimal outcomes for the members
• Appropriately apply the program guidelines to the individual cases reviewed
• Work autonomously to prioritize and manage workload
• Document effectively in appropriate systems, including outputs supported by AI tools and electronic data ingestion processes
• Comply with all organizational HIPAA requirements and ensure proper handling of electronic transaction data
• Support process improvements related to automation, using AI tools and electronic data ingestion workflows
• Contribute to the exercise and expression of the Ministry’s Christian beliefs
• All other duties as assigned

Essential Skills & Abilities

• Understanding of medical bill processing and provider bill negotiation
• Knowledge and practical application of AI-assisted medical review tools and clinical decision support technologies
• Ability to understand Availity 278 transactions and electronic pre-service eligibility workflows
• Ability to interpret structured electronic data and integrate it with clinical documentation during the medical review process
• Ability to multitask in multiple operating systems
• Ability to work for extended periods of time on the computer
• Proficiency in interpreting medical records and writing detailed reports and conclusions
• Strategic understanding of negotiations, third party processes, bill validation, and care management to determine when to utilize/defer to these processes for active review cases
• Ability to be objective and impartial and conclude a case
• Ability to communicate effectively with both internal and external customers
• Interpersonal skills and ability to work as a member of a team
• Ability to adapt to changing processes
• Working knowledge and application of program guidelines
• Understanding of systems and workflows as they relate to the type of review or assignment
• Ability to utilize the internet including e-mail and search engines
• Word processing skills of at least 25 wpm
• Basic knowledge in Microsoft Office (Excel, Word, Outlook, Teams) and ability to use a database system
• Knowledge of document imaging system

Core Competencies/Demonstrable Behaviors

• Action Oriented – taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
• Plans and aligns – planning and prioritizing work to meet commitments aligned with organizational goals
• Member First – exhibits full commitment to serving members and/or clients by prioritizing their needs first in alignment with our program’s purpose.  This commitment is demonstrated through understanding of the program(s), provided through quality and timely service while exercising empathy in every interaction.  Every CCM employee shares responsibility to steward resources faithfully, removing barriers to understanding, and creating accessible, connected, and Christ-centered experiences.
• Humble – demonstrates Christ-Centered humility by honoring others, accepting feedback, and prioritizing collective success over individual recognition
• Hungry – exhibits initiative, perseverance, and commitment to serving God through excellence.  Demonstrates passion for personal and organizational growth while diligently advancing the mission of Christian Care Ministry
• Smart – shows relational and emotional intelligence, communicates effectively, collaborates harmoniously, and reads social cues with grace and discernment

Education and/or Experience

• Current Unrestricted LPN/LVN license with 5+ years’ experience in a healthcare payer industry or RN license with sound knowledge of anatomy and physiology and disease processes
• 1-3 years’ experience in medical reviews required
• 2-3 years of clinical experience strongly preferred
• Experience with Utilization Review or Case Management preferred

Supervisory Responsibilities

• This job has no supervisory responsibilities

Incentives & Benefits

We work hard to serve our Medi-Share Members, but know we can only do that if we invest in our employees professionally, financially, physically, socially, and spiritually. We purposefully invest in our employees so that our employees can invest in others.

For full-time employees working 30 hours or more, some of our benefits include, but are not limited to:

• 100% paid Medical for employees/99% for family
• Generous employer Health Savings Account (HSA) contributions
• Employer-paid Life Insurance (3x salary) and Long-term Disability Insurance
• 6 weeks of paid parental leave (for both mom and dad)
• Dental - two plans to choose from
• Vision
• Short-term Disability
• Accident, Critical Illness, Hospital Indemnity
• 401(k) – up to 4% match on ROTH or Traditional contributions
• Generous paid-time off and 11 paid holidays
• Wellness plan including Financial, Occupational, Mental/Spiritual, and Physical health incentives up to $50/mo
• Employee Assistance Program including no cost, in-person mental health visits and employee discounts
• Monetary Anniversary Awards Program
• Monetary Birthday Awards
• Tuition Reimbursement Program

Minimum Age Requirement: Due to the nature of the responsibilities associated with this position—including independent decision-making, access to confidential information, and potential exposure to regulated environments—candidates must be at least 18 years of age at the time of hire. This requirement is in accordance with applicable federal and state labor laws and is intended to ensure compliance with workplace safety and legal standards.

The range for this role is $31.97 per hour to $43.51 per hour

Actual base pay will be determined based on a successful candidate’s work location, skills/abilities, experience, and education.

Interested applicants must be willing and able to work onsite minimum 4 times per week in either our Melbourne, FL or Orlando, FL office.

The Mission

At Christian Care Ministry we believe that Christians can, and should, share in one another’s burdens. Through the use of Medi-Share®, a healthcare sharing ministry for Christians, we cultivate that belief. To that end, our Mission Statement is as follows: Connecting people to a Christ-centered community wellness experience based on faith, prayer, and personal responsibility.

The Team

Everyone at Christian Care Ministry is in agreement with our Statement of Faith, which outlines our core beliefs. Although we aren’t perfect people, we are serving our perfect God and our Members to the best of our ability.

The Job

The Senior Clinical Reviewer works to summarize and correlate concise, accurate information on medical reviews to determine eligibility of medical bills per the program guidelines. In this role, 70% of the time is spent performing pre-service and post-service medical reviews and/or reviews for high dollar, complex medical cases and collaborating with other departments to optimize cost savings.  This position leverages AI-enabled clinical review tools and electronically ingested data (278 transactions) to enhance the accuracy, efficiency, and consistency of medical reviews.  The Senior Clinical Reviewer will be expected to make decisions regarding timing and omission of medical reviews in deference to other department processes based on the dollar amount of the bill and the Ministry’s cost strategy.

Essential Job Duties & Responsibilities

• Organize and review medical records, lab results, radiology, and pathology reports for conditions ineligible for sharing (CIF’s)
• Determine eligibility of members’ medical bills and/or upcoming procedures/treatments according to the program guidelines
• Perform pre-service and post-service medical reviews utilizing AI-enabled clinical review tools to make evidence-based, consistent, and efficient determinations of sharing eligibility
• Review and interpret pre-service eligibility data (via 278 EDI transactions) to support streamlined medical review workflows
• Integrate structured electronic data with clinical documentation to support accurate and timely eligibility determinations
• Collaborate with other departments to maximize cost savings for individual cases and optimal outcomes for the members
• Appropriately apply the program guidelines to the individual cases reviewed
• Work autonomously to prioritize and manage workload
• Document effectively in appropriate systems, including outputs supported by AI tools and electronic data ingestion processes
• Comply with all organizational HIPAA requirements and ensure proper handling of electronic transaction data
• Support process improvements related to automation, using AI tools and electronic data ingestion workflows
• Contribute to the exercise and expression of the Ministry’s Christian beliefs
• All other duties as assigned

Essential Skills & Abilities

• Understanding of medical bill processing and provider bill negotiation
• Knowledge and practical application of AI-assisted medical review tools and clinical decision support technologies
• Ability to understand Availity 278 transactions and electronic pre-service eligibility workflows
• Ability to interpret structured electronic data and integrate it with clinical documentation during the medical review process
• Ability to multitask in multiple operating systems
• Ability to work for extended periods of time on the computer
• Proficiency in interpreting medical records and writing detailed reports and conclusions
• Strategic understanding of negotiations, third party processes, bill validation, and care management to determine when to utilize/defer to these processes for active review cases
• Ability to be objective and impartial and conclude a case
• Ability to communicate effectively with both internal and external customers
• Interpersonal skills and ability to work as a member of a team
• Ability to adapt to changing processes
• Working knowledge and application of program guidelines
• Understanding of systems and workflows as they relate to the type of review or assignment
• Ability to utilize the internet including e-mail and search engines
• Word processing skills of at least 25 wpm
• Basic knowledge in Microsoft Office (Excel, Word, Outlook, Teams) and ability to use a database system
• Knowledge of document imaging system

Core Competencies/Demonstrable Behaviors

• Action Oriented – taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
• Plans and aligns – planning and prioritizing work to meet commitments aligned with organizational goals
• Member First – exhibits full commitment to serving members and/or clients by prioritizing their needs first in alignment with our program’s purpose.  This commitment is demonstrated through understanding of the program(s), provided through quality and timely service while exercising empathy in every interaction.  Every CCM employee shares responsibility to steward resources faithfully, removing barriers to understanding, and creating accessible, connected, and Christ-centered experiences.
• Humble – demonstrates Christ-Centered humility by honoring others, accepting feedback, and prioritizing collective success over individual recognition
• Hungry – exhibits initiative, perseverance, and commitment to serving God through excellence.  Demonstrates passion for personal and organizational growth while diligently advancing the mission of Christian Care Ministry
• Smart – shows relational and emotional intelligence, communicates effectively, collaborates harmoniously, and reads social cues with grace and discernment

Education and/or Experience

• Current Unrestricted LPN/LVN license with 5+ years’ experience in a healthcare payer industry or RN license with sound knowledge of anatomy and physiology and disease processes
• 1-3 years’ experience in medical reviews required
• 2-3 years of clinical experience strongly preferred
• Experience with Utilization Review or Case Management preferred

Supervisory Responsibilities

• This job has no supervisory responsibilities

Incentives & Benefits

We work hard to serve our Medi-Share Members, but know we can only do that if we invest in our employees professionally, financially, physically, socially, and spiritually. We purposefully invest in our employees so that our employees can invest in others.

For full-time employees working 30 hours or more, some of our benefits include, but are not limited to:

• 100% paid Medical for employees/99% for family
• Generous employer Health Savings Account (HSA) contributions
• Employer-paid Life Insurance (3x salary) and Long-term Disability Insurance
• 6 weeks of paid parental leave (for both mom and dad)
• Dental - two plans to choose from
• Vision
• Short-term Disability
• Accident, Critical Illness, Hospital Indemnity
• 401(k) – up to 4% match on ROTH or Traditional contributions
• Generous paid-time off and 11 paid holidays
• Wellness plan including Financial, Occupational, Mental/Spiritual, and Physical health incentives up to $50/mo
• Employee Assistance Program including no cost, in-person mental health visits and employee discounts
• Monetary Anniversary Awards Program
• Monetary Birthday Awards
• Tuition Reimbursement Program

Minimum Age Requirement: Due to the nature of the responsibilities associated with this position—including independent decision-making, access to confidential information, and potential exposure to regulated environments—candidates must be at least 18 years of age at the time of hire. This requirement is in accordance with applicable federal and state labor laws and is intended to ensure compliance with workplace safety and legal standards.