Legal Support member

Life Molecular Imaging GmbH (LMI) is a German-based Research & Development (R&D) organization focused on developing PET imaging solutions for diseases with high unmet medical needs. Our vision is to build our position as an innovator and leading player in the Molecular Imaging field. We aim to create value for patients & physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.

Ihre Aufgaben

Life Molecular Imaging GmbH is looking for a qualified German- or UK-qualified paralegal or business lawyer with a strong interest in or experience with contract law, ideally also in drafting and negotiating contracts, as well as a keen understanding of legal matters related to the pharmaceutical and life sciences industries. As a Legal Support member, you will work closely with our Legal Counsel EU, collaborate with EU and UK management teams, and liaise with our US-based Head of Legal. This role requires business fluency in English, expertise in international legal matters, and is preferably based in Berlin or Brandenburg.,

• Contract Drafting and Review: Assist in the drafting, review, and negotiation of various contracts, including but not limited to supply agreements, licensing agreements, research collaborations, clinical studies and vendor contracts.

• Data Protection Compliance: Ensure that the company's data processing activities comply with applicable data protection laws, including the General Data Protection Regulation (GDPR) and other relevant regulations. This includes reviewing data protection impact assessments, advising on data transfer mechanisms, and managing data protection inquiries and incidents.

• Legal Research: Stay updated on relevant laws, regulations, and industry trends within the pharmaceutical and life sciences sectors and data protection to provide informed legal guidance.

• International Collaboration: Work closely with cross-functional teams across different geographical locations, ensuring legal compliance, data protection, and risk mitigation in international transactions and operations.

• Support for Legal Counsel EU: Collaborate with the Legal Counsel EU in managing legal documentation, maintaining records, ensuring data protection processes are efficient and compliant, and addressing data protection-related issues.

• Regulatory Compliance: Assist in ensuring that the company's activities, especially those involving data processing, comply with relevant regulatory requirements, including those in the pharmaceutical and life sciences sectors and data protection laws.

• Team Collaboration: Engage in legal discussions, provide legal guidance on data protection matters to various departments, and participate in legal strategy discussions with the legal team., 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.

Ihr Profil

• Paralegal or business lawyer certification (Wirtschaftsjurist) or a related field.

• Strong interest in or prior experience with contract law, ideally incl. drafting and negotiating contracts.

• Knowledge or experience in pharmaceutical and life sciences legal matters is a significant advantage.

• Familiarity with data protection laws, including GDPR.

• Business fluent in English, both written and spoken.

• Experience in handling international legal matters, data protection compliance, and transactions.

• Intercultural empathy

• MS Office skills, especially Word, Excel, and PowerPoint

• Preferred residence in Berlin or Brandenburg, Germany.

Wir bieten Ihnen

• Competitive salary.

• Flexible work hours, including the option for remote work.

• Opportunity to work with a passionate and innovative team dedicated to improving healthcare.

• A collaborative and supportive work environment.

  If you are a dedicated legal professional with a passion for contract law, pharmaceuticals, life sciences, and data protection, and are excited to contribute to our mission, we encourage you to apply for this full-time position. Join Life Molecular Imaging GmbH and be a part of a team committed to making a difference in the world of healthcare.

  Please send us your application as a single pdf document to the below e-mail address. Don't forget to include a cover letter detailing your interest in this position and your past relevant work experience and a resume.

  Annekathrin Kirchner jobs@life-mi.com Life Molecular Imaging GmbH Tegeler Str. 6-7 13353 Berlin

  We are looking forward to receiving your application!

  *The person counts, not the gender! Life Molecular Imaging is committed to diversity, rejects discrimination, and does not think in categories such as gender, ethnic origin, religion, disability, age, or sexual identity. Life Molecular Imaging GmbH 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. 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.

Kontakt

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