- Merck & Co. (Boston, MA)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director , Quantitative Systems Pharmacology (QSP) . QP2-IO team is ... of oncology drugs from post-PCC to registration. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is ... responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You ... **How you will contribute:** + Defines, develops, and leads global strategies to maximize global regulatory...in collaboration with their regional counterparts. + As the Associate Director , you will be responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee the… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible ... commercialization and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs. Responsibilities and Duties + Act as the… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** ** Associate Director , US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical** ... the role:** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review....regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide… more
- Merck (Boston, MA)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The ... system aspects are integrated + Stay abreast of evolving global regulatory landscapes for medical device and...+ Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and … more
- Takeda Pharmaceuticals (Boston, MA)
- …the development of scientific communications strategy and deliverables, the ** Associate Director , Scientific Communications Lead, Hematology** proactively ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...in life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead, develops and… more
- Merck (Boston, MA)
- **Job Description** The Global Scientific Training Associate Director is accountable for these core activities: + ... Medical Value Capabilities functional areas, and Regional Field Medical Leadership. The Global Scientific Training Associate Director must possess subject… more
- Takeda Pharmaceuticals (Boston, MA)
- …leadership at LOC level Decision-making and Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support ... Access, Global Evidence and Outcomes, Medica Affairs, Clinical Development, Regulatory Affairs, Biostatistics, Global Emerging Markets (GEM; eg, China),… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **OBJECTIVES:** Global Evidence and Outcomes (GEO) contributes to the successful development and ... analysis plans, scientific reports, briefing packages, clinical study reports, and regulatory labelling interactions. + Provide technical expertise and guidance on… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **OBJECTIVES:** As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the ... decks, statistical analysis plans, briefing packages, clinical study reports, and regulatory labelling interactions. Ensure these reflect the COA needs from key… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and/o academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 ... While not essential, prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced understanding of drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Managesanyreportingstaff(Takeda employeesand/orcontractors). + Preparesorsupervisespreparationofhigh-quality DP-CMCsectionsfor Global regulatory filings to ... knowledge. **Job Description** **Objective:** Under the direction of the Director or Sr. Director , ODPD, the Assoc....knowledge of current GMP regulations. + Detailed knowledge of Global regulatory requirements for drug products. +… more
- IQVIA (Boston, MA)
- **MSL Associate Director ** We are excited to announce that currently we are looking for **Medical Science Liaison Associate Director and Player-Coach** ... contribute clinical insight to inform decision making on various aligned teams. The **MSL Associate Director & Player Coach** will have all of the functional… more
- Merck (Boston, MA)
- …and Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role of Associate Director , Quantitative Systems Pharmacology (QSP). QP2-IO team is ... post-PCC to registration. As a subject matter expert, the Associate Director within the QP2-IO Group will...analyses on programs + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and… more
- Takeda Pharmaceuticals (Boston, MA)
- …provider's needs, enhance patient experience, and remain compliant with company and regulatory standards. As the Associate Director , Patient Services ... grounded in purpose and be empowered to deliver your best. Join Takeda as the Associate Director , Patient Services Operations out of our Cambridge, MA office. As… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced ... by Design (AQbD) principles, aligning with ICH Q14, ICH Q2(R2), and global regulatory expectations for biologics. + Lead technical assessments and risk analyses… more
