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2 days
Not Specified
Not Specified
$44.44/hr - $79.76/hr (Estimated)
<p>Legal Support for Development Development currently has 9 active clinical programs with expected new clinical programs in the coming year (approximately 10 studies in planning or soon to be initiated). Clinical trials are currently being conducted in 50+ countries, with a focus on the US, Canada, UK and EU member states. R&D Legal provides legal and strategic advice associated with these global clinical program strategies (including Regulatory, Development, Global Patient Safety & Risk Management, Clinical Operations, Data Sciences). Partner with Vice President, General Counsel, Research & Development and Legal Director in providing timely legal and strategic advice to Development including the following: Interpretating laws/regulations/guidance in any of the 50+ countries where Alnylam clinical trials are conducted or where Alnylam has legal and/or regulatory obligations in carrying out its clinical programs. Advising on any associated risks in complying with such laws/regulations/guidance. Serve as in-house expert in EU and UK laws/regulations impacting global clinical trials. Expertise in advising on in vitro diagnostic regulations (e.g. IVDR regulations) a plus. Serve as legal member on program-related and operational boards/committees, as assigned. Assessing clinical programs and strategy, as well as, underlying policies and procedures, for any legal risks associated with product liability, fraud & abuse, human subject research protections/ethics, privacy, regulatory compliance. Advise on risks associated with government actions or pending, new or existing legislation impacting global clinical programs. Provide legal support to ClinOps and Clinical QA in assessing allegations, conducting investigations, and meeting legal/regulatory reporting requirements. Provide legal, business and strategic advice on relationship support by interpreting contract language for internal business partners to help avoid and/or resolve potential issues. Provide best-in-class legal support for policies, processes, templates, governance principles and support structures that allow Alnylam to successfully grow and scale globally. Contribute to process improvements across our Legal department and organization, as needed. Juris Doctor degree required Minimum 6+ years' experience dedicated to advising on R&D functions (including Regulatory, Development, Global Patient Safety & Risk Management, Clinical Operations, Data Sciences) either in-house and/or a nationally recognized law firm). Expertise in EU and UK laws/regulations impacting global clinical trials. Working knowledge/experience advising on in vitro diagnostic regulations (e.g. IVDR regulations) a plus. Experience drafting and negotiating R&D agreements. Experience in partnering with R&D legal colleagues and business partners to provide advisory and strategic support to global clinical trials. Experience or knowledge in supporting Development organizations Demonstrated exceptional communication skills, including presentation, interpersonal interactions, and written communications Experience effectively working with all levels in the organization Demonstrated commitment to finding solutions, relationship building, continued learning, proactivity and a high sense of confidentiality Excellent interpersonal skills that are demonstrated by being articulate, direct and forthright, and serving as a collaborative and decisive team member and a strategic thinker with a broad perspective Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations Willing to support any areas of Global R&D, as needed. Demonstrated ability to own projects and consistently meet tight timing requirements and high quality standards Strong verbal and written communication skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.</p>
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