Career Opportunity

Compliance Manager – US

Life Molecular Imaging (LMI) is a global, innovative R&D company focusing on the development and commercialization of molecular imaging radiopharmaceuticals for our approved F-18 amyloid PET tracer Neuraceq® and a pipeline of PET tracers in clinical development. Our vision is to create value for patients and physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.

Compliance Manager - US

Candidates must reside in the Eastern or Central time zones, with Eastern being the preferred to support business needs and interact with global departments.

Summary:
The Compliance Manager is responsible for developing, revising, implementing, and promoting awareness of LMI’s business ethics policies, monitoring the organization’s standards of conduct and ethical relationships with customers, contractors, suppliers, employees, and the communities in which business is conducted. Administer and maintain an effective compliance program for a growing pharmaceutical company, being commercially active in the US, EU and UK.
The responsibilities below do not represent the entirety of the role but rather an overview of some of the key tasks.

Key Responsibilities & Requirements::

  • Maintain an effective compliance communication program for the organization, including promoting: (a) use of the compliance hotline; (b) heightened awareness of Code of Conduct and applicable compliance policies and procedures, and (c) understanding of new and existing compliance issues and related policies and procedures.
  • Oversee and actively manage development and regular revision of compliance policies and procedures designed to prevent illegal, unethical, or improper conduct and evaluate the need for additional policies and procedures.
  • Conduct Risk Assessment and Mitigation Planning (RAMP) with applicable business groups.
  • Perform third party due diligence per LMI policy and create third party due diligence reports for stakeholders.
  • Identify potential areas of compliance risk and implement corrective action plans for resolution of problematic issues.
  • Chair the LMI Compliance Committee and be an active leader for Compliance.
  • Develop and implement compliance audit/monitoring plan for the year and ongoing to remain abreast of compliance activities.
  • Bachelor’s degree required; advanced degree preferred (i.e., Law Degree); license to practice law highly preferred.
  • Minimum 5 years of experience working as in-house compliance in related medical devices, biotechnology or pharmaceutical industry.
  • Three years of experience leading and working with departments on compliance Risk Assessment and Mitigation Plans (RAMPs).
  • Demonstrated compliance policy and standard operating procedure drafting experience.
  • Internal investigations experience.
  • In depth understanding of risks facing a global pharmaceutical company including Anti-Bribery, Anti-Corruption, 3rd party distributors, Open Payments, Anti-Kickback, etc.

What we expect:
At LMI, success stems from adaptability, resilience, and a commitment to our mission. We seek individuals who thrive in a dynamic, rapidly evolving environment and embrace the challenges and opportunities that come with growth. Our ideal candidates are proactive, solution-focused professionals who share our passion and work ethics for advancing neuroimaging technology to transform the lives of patients affected by Alzheimer’s and other neurodegenerative diseases.

What you can expect:
A rewarding and challenging career with the support of coworkers, managers, and other divisions of a global company. You will be able to make significant contributions through your expertise. You can expect what YOU do to matter, as all our employees are an integral part of a global organization as well as the patients and communities we serve. The salary range for this position is $125-130,000, along with a competitive benefits package including medical, dental, vision, life & disability, 401k, and PTO.

Life Molecular Imaging, Inc. is an Equal Opportunity Employer. We believe what we do and our culture of “More Than a Job. It’s Making Life Better” extends to creating a welcoming, safe, and inclusive work environment. If you have what it takes and the passion to make a difference, please apply.

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Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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