- Orchard Therapeutics (Boston, MA)
- …on design of clinical development strategies and protocols that meet strategic, scientific and regulatory objectives of Orchard's clinical assets . Cultivate ... effective cross-functional collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory , Medical Affairs , Pharmacovigilance and other teams… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. + Ability to broadly… more
- Bristol Myers Squibb (Cambridge, MA)
- …plan (IDP) in partnership with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug ... maximize program impact + Actively supports Investor Relations and Public Affairs in managing external BMS communications **Integrates commercialization inputs and… more
- Genentech (Boston, MA)
- …practices + Partner closely with senior leadership across PD-DSA, clinical development, regulatory affairs , and data science teams to shape the future of ... and excellence in therapy area-level governance / Development Boards to ensure scientific rigor in study design, analysis, and interpretation + Evaluate challenges… more
- Bausch + Lomb (Boston, MA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- Takeda Pharmaceuticals (Boston, MA)
- …with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification. ... various key stakeholder functions (eg. Clinical, Clinical Operations, Medical Affairs , Commercial, Medical Writing) and represents Nonclinical and Translational… more
- Takeda Pharmaceuticals (Lexington, MA)
- …strategies and tactical plans. + Thorough understanding of legal, compliance, and regulatory guidelines related to medical affairs in the pharmaceutical ... USBU and Global level on relevant internal meetings, understanding the US scientific and medical landscape and patient/medical journey for assigned pipeline assets… more
- Takeda Pharmaceuticals (Boston, MA)
- …within the CoE of Global Medical. + Provides innovative thinking and scientific expertise into peri- and post-approval research programs and real-world evidence ... of a strategy for all study types within Global Medical, ie Medical Affairs Sponsored Studies (MACs). Also, develops Areas of Interest (AOI) for Collaborative… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... data from various sources including non-clinical, clinical, post-marketing and scientific literature. + Conduct signal detection, monitoring, evaluation, interpretation,… more
- Sanofi Group (Cambridge, MA)
- …leaders, patient advocacy associations, clinical development, Global Medical Leadership, Regulatory , Medical Affairs , Product Communications, and lead agency ... and science story in partnership with Clinical Development and Global Medical Affairs . + Provide oversight and commercial accountability for Global Corporate … more