United States onlyTITLE:
Medical ReviewerTitle: Medical Reviewer
Reports to: Associate Medical Director, US Medical Affairs
Location: Field Based
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of OUD. Indivior is dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
POSITION SUMMARY:
A US Medical Reviewer is responsible for providing input, insight, and direction related to monitoring medical literature/guidelines for company product(s), disease state and relevant competitor data. This position serves as a therapeutic team resource for product information and participates in cross-functional initiatives as needed. The position is also responsible for ensuring high quality therapy area input and review of promotional and non-promotional communications/materials through the Medical/Legal/Regulatory review process.
ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:
- Searches, reviews, and summarizes the available data in the published literature, medical textbooks, and internal documents (e.g., study protocols/reports) to develop high quality responses to requests for information on the clinical efficacy and safety of marketed/investigational products.
- Reviews Medical Information Response Documents to ensure responses reflect all currently available medical information.
- Conducts medical review to ensure/verify clinical accuracy of promotional and non-promotional materials produced by internal business partners through their role on the Medical Review Committee (MRC) and Promotional Review Committee (PRC). Executes the role as described in the MRC and PRC Standard Operating Procedures.
- When necessary, provides written responses to health care professionals requesting medical information by evaluating and synthesizing pertinent data from the scientific literature.
- Maintaining strong understanding of compliance standards and regulations governing the pharmaceutical industry of surrounding creation and utilization of promotional and non-promotional scientific exchange materials.
- Utilizes the appropriate information resources to identify published literature and respond to medical information inquiries.
- As requested, provides medical/clinical support for sales training initiatives for current products, label changes, and drug product launches by reviewing and creating sales training materials and participating in clinical training for commercial colleagues and others as required.
- Collaborate with Medical Affairs, FMP and Commercial to prepare for the launch of a new product, new indication or new clinical data (e.g., creation of a medical information database, dossiers, therapeutic slide decks, and training materials), as needed.
- Assist with the creation and updating standard medical information content on Indivior products utilizing the highest level of evidence; critically evaluate the data with the focus that the information can be shared with HCPs and KDMs by all Indivior local operating companies, as needed
- Maintain high level awareness and understanding of MI and other Medical Affairs policies, procedures, processes, and their application to maintain compliance
- Ensure compliance with timelines, principles and guidelines outlined in all applicable Medical Information control documents for acknowledging and addressing internal stakeholder enquiries
- Support manager in development of team objectives, ensure strong rapport, trust and credibility with key internal stakeholders.
- Assumes the lead on key projects for Medical Affairs and coordinates with interdisciplinary partners as required.
- Contribute to Medical Affairs projects to develop best practices, ways of working and continuous improvement initiatives for creation and delivery of medical information.
- Performs other responsibilities as assigned.
BASIC QUALIFICATIONS:
- PharmD, MD, PhD or other healthcare professional
- Previous experience in pharmaceutical industry in a Medical Affairs/Medical Information or similarly relevant role
- Strong scientific/medical background
- Demonstrated high quality medical communication (verbal/written) skills
- Highly proficient at literature searching with a full understanding of levels of evidence and ability to critically evaluate scientific literature for clinical applicability
PREFERRED QUALIFICATIONS:
- Demonstrated ability to understand and apply policies and guidance
- Previous or current clinical experience in a healthcare setting
- Strong understanding of the value of the Medical Information and Communication functions
- Experience in Medical Content development
- Strong communication and ability to adapt communication to the audience
- A high level of analytical and critical thinking to assimilate, understand and communicate information from different sources
- Ability to work with minimal supervision; highly effective at planning, prioritizing, and managing different tasks
- Strong attention to detail
- Ability to adapt and work in a fast paced, changing environment
- Demonstrated ability to work in an interdisciplinary, cross-functional team
- Proficient at common office-based computer applications
- Relevant therapeutic background desired
BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
3 weeks’ vacation plus floating holidays and sick leave
401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
U.S. Employee Stock Purchase Plan- 15% Discount
Comprehensive Medical, Dental, Vision, Life and Disability coverage
Health, Dependent Care and Limited Purpose Flex Spending and HSA options
Adoption assistance
Tuition reimbursement
Concierge/personal assistance services
Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
Gym, fitness facility and cell phone discounts
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
COMPLIANCE OBLIGATIONS:
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:
Employee Obligations:
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Risk IQ: Know what policies apply to your role and function and adhere to them.
Speak Up: If you see something, say something.
Manager Obligations:
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
