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    Legal Director, Regulatory Affairs - London, United Kingdom - Moderna Therapeutics

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    Description

    Moderna is seeking a Director, Legal UK who will be responsible for providing best in class legal support for Moderna's growing presence in the UK, Europe and Middle East.

    The role is strategically important in supporting Moderna's build, presenting opportunities to counsel across the enterprise on local legal requirements, regulatory matters, construction, manufacturing, alliance management, commercialisation and market access.

    The successful candidate will play an instrumental role in the scale up of this platform-based biotechnology company, and in building legal support to support long-term growth.

    Serve as the legal lead for the UK and other affiliates and/or alliance management teams across Europe and Middle East, participating in leadership teams as a strategic business partner.

    Partner and collaborate cross-functionally, leveraging global expertise, technology and capabilities, to act as enterprise connector and maintain global excellence and compliance.

    Provide legal support for the successful construction and operation of Moderna's first mRNA manufacturing facility and R&D centre in the United Kingdom.

    Partner with supply chain, manufacturing, quality and procurement teams and provide support operations of the mRNA facility.

    Partner with research and clinical development and provide support to enable local R&D activities including clinical site startup, vendor outsourcing and strategic collaborations.

    Support contract implementation and dispute resolution (if applicable) related to R&D, manufacturing, supply chain, distribution, commercial, medical affairs and strategic matters.

    Support on GxP and regulatory compliance topics, including interactions with health authorities.
    Advise on engagement with patient organizations and health care professionals and support medical affairs/scientific engagement activities.
    Support Government Affairs activities, including engagement with industry associations.
    Participate in promotional review, grant review, and medical review committees.

    Support the digital delivery of scientific engagement and promotional content, providing guidance on the General Data Protection Regulation and other privacy laws and regulations.

    Advise on engagement with patient organizations and health care professional organizations.
    Collaborate with Compliance to mitigate enterprise risk, including supporting the drafting and implementation of SOPs and policies.

    Be curious about Moderna's mRNA platform and relentlessly support its commercialization for a potential COVID-19 vaccine and in other modalities.

    Legal qualification from an accredited law school; Minimum 7+ years of post-qualification experience in private practice, pharmaceutical and/or biotech industry.

    Ability to collaborate and provide support across a broad range of key areas and with a variety of functional stakeholders, including marketing, scientific engagement, supply chain, finance, medical, pharmacovigilance, manufacturing, quality, procurement, engineering, contracting, communications, and business development.

    Intense sense of urgency, curiosity, and ambition to excel and build something from the ground up, navigating all the requisite ambiguity and complexity that comes with writing the rulebook while executing in real time.

    Professional competence English required and a second European language preferred.
    We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
    Quality healthcare and insurance benefits
    Lifestyle Spending Accounts to create your own pathway to well-being
    Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown

    By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

    Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

    We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

    Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
    Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.

    Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at .We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

    To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

    Our Vision :

    To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

    Third Party Staffing Agencies

    For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.

    Reasonable Accommodation Notice
    Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.

    Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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