Legal Counsel-US

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 visit our website to learn more. www.life-mi.com

Ihre Aufgaben

The Legal Counsel-US will be responsible for managing and overseeing US legal work and activities pertaining to the Life Molecular Imaging's Commercial and Medical Affairs divisions. Will draft, review, and negotiate commercial and R&D contracts; create and advise on contract templates, and provide legal advice on corporate, compliance and commercial matters from draft to execution. Will support internal and external audits, aspects of the group compliance program and complementary policies for the US territory.

The responsibilities below do not represent the entirety of the role but rather an overview of some of the key tasks. This position will be responsible for the US and will support Rest of World (RoW) activities. Therefore, you must be able to work outside the normal business hours to support other time zones. You will also need to be able to travel to sites across the US, and potentially internationally when needed. This position is fully remote and will be located on the Eastern Time Zone.

Key Tasks and Responsibilities:

• Understands the regulatory environment (particularly within healthcare market sector) and remains up to date to ensure legal compliance by creating, updating, implementing, monitoring, and enforcing policies, procedures, guidelines, and manuals.

• Identifies risks and ensures that such risks are allocated appropriately to protect the business.

• Provides legal advice to Compliance, Commercial, Medical Affairs and Operational parts of the Life Molecular Imaging business in US (potentially and partially as applicable to ROW) including commercial and corporate law.

• Drafts, negotiates, and reviews commercial contracts covering the entire supply chain.

• Supports Medical Affairs Division in pre-clinical and clinical activities, research, commercial support, and interactions with health care professionals.

• Liaise as needed with US tax and insurance consultants as needed.

• Uses and maintains the contract management system for all contracting.

• Supports implementation and maintenance of the group compliance program and complementary policies.

  What we expect: To be successful in this role, you must be able to handle working in a fast-paced, time sensitive critical industry, with strong attention to detail, with ability to function independently and deliver agreed upon results. Candidates must be a licensed attorney in at least one US jurisdiction with a minimum of three years of experience in medical devices, biotechnology, pharmaceutical or life sciences. Be familiar with radiopharmaceuticals in pre-commercial and post approval (FDA NDA/INDs) settings. We are looking for people who are just as passionate as we are to improving the lives of those with Alzheimer's and other neurodegenerative diseases.

  What you can expect: LMI is seeking candidates who are up for a challenge while being supported by their 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 communities we serve., 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.

Kontakt

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