- United Therapeutics (Research Triangle Park, NC)
- …Who You Are You are creative and detail-oriented with deep expertise in regulatory submissions and writing, including clinical study reports, clinical ... independently to research, write, and edit abstracts, manuscripts, posters, and several regulatory documents including but not limited to: clinical study… more
- Johns Hopkins University (Baltimore, MD)
- …insurance referral and preauthorization requirements, patient relations and satisfaction, clinical regulatory compliance, and program marketing for all ... responsibility and works collaboratively with the division leadership team to meet clinical practice goals and objectives. The Clinic Manger proactively assesses and… more
- AbbVie (South San Francisco, CA)
- …highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients. ... development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, or GMA) to create development… more
- AbbVie (North Chicago, IL)
- …+ interpreting statistical data to prepare written medical and scientific reports for regulatory bodies; + clinical regulatory writing experience following ... development, clinical research, study designs, & biostatistics to author clinical regulatory documents; + performing medical writing in the… more
- AbbVie (North Chicago, IL)
- …development and drive alignment with functional management. Partner with other functions ( Clinical , Regulatory , Patient Safety, or GMA) to create development ... Purpose The Associate Director, Statistics provides statitical leadership for clinical development and life-cycle management strategies for assigned projects.… more
- Rhythm Pharmaceuticals (Boston, MA)
- …Director of Data Science to lead data-driven initiatives in support of our clinical , regulatory , and scientific objectives. The successful candidate will have a ... role will work collaboratively with key inter-disciplinary stakeholders (eg biostatistics, clinical development and regulatory affairs) to drive the generation… more
- Takeda Pharmaceuticals (Boston, MA)
- …to work collaboratively with diverse teams across different functions, including clinical , commercial, regulatory , and digital health. + Adaptability: Capacity ... Risk Management: Ability to identify, assess, and mitigate risks associated with clinical trials, regulatory compliance, and market access. + Stakeholder… more
- Abbott (Santa Clara, CA)
- …(KOLs) and collaborating cross functionally with other departments including Global Clinical Operations, Research & Development, Regulatory Affairs, and ... of clinical results at industry gatherings, investigational meetings and regulatory agency meetings. + Works collaboratively with R&D, Clinical R&D,… more
- System One (New Brunswick, NJ)
- …on high quality technical reports. + Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets. + Manage the ... authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses… more
- AbbVie (North Chicago, IL)
- …ensuring that the CMC submission strategy is aligned closely with the clinical / regulatory development strategy and provides drug development experience and ... Irvine, South San Francisco, Worcester MA, Waltham, MA Leads global regulatory dossier preparation activities for novel biologics by coordinating cross-functional… more