Collaborates with medical writing to author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program. 10 years of pharmaceutical clinical drug development experience Experience within CNS, Rare Disease or Cardio-metabolism preferred Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH) Ability to manage multiple competing priorities with good planning, time management and prioritization skills Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports Interact with key stakeholders across Clinical Development functional areas Problem solving, prioritization, conflict resolution and critical thinking skills Strong communication, technical writing, and presentation skills experience