The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval... on how best to interpret the regulatory legislation and guidelines. The Regulatory Affairs Nonclinical / Clinical team plays a key role...
+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related...Responsibilities: Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments...
in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, with additional duties in Canada... to Regulatory Affairs and other departments as appropriate. Review and provide input and communicate externally on regulatory...
Job Title: Associate Director Global Regulatory Affairs Location: Cambridge, MA 02142 Duration: 06+ Months...: knowledge of US Regulatory Affairs Recommended experience: 0-3 years for Associate level, 4-7 years Intermediate level, and 8...
Job Description General Summary: The Medical Affairs Senior Director provides medical and scientific leadership... of Nephrology medical plans. Key Duties and Responsibilities: Develops medical affairs plans, including Launch and Life Cycle...
Analysis Manager you will Monitor regulatory developments released by the U.S. banking agencies and the Basel Committee... Collaborate with the Regulatory Affairs group and engage with industry forums to recommend enhancements to proposed regulations...
Position Overview Bicara Therapeutics is seeking a Manager - Senior Manager of Clinical Supply Chain to lead clinical... with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability...
Job Description General Summary: Vertex Pharmaceuticals Inc. is seeking a Senior Manager for Government Pricing... includes Government Pricing (GP) and State Transparency Reporting. The Senior Manager position is a new and critical role...
. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager... of Statistics- CMC in our Cambridge, MA office. As a Senior Manager of Statistics, you will provide statistical leadership in the...
for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison... States of America Job Description: Johnson & Johnson Innovative Medicines is recruiting for a Senior Medical Science...
of references (if available), and submit a cover letter addressed to 'Hiring Manager Senior Budget Analyst' position. We will ensure... addressed to 'Hiring Manager Senior Budget Analyst' position. We will ensure that individuals with disabilities are provided...
of social platform innovations and best practices Navigate the intersection of corporate affairs, regulatory environment...Senior Vice President, Client Experience, Corporate Health About Weber Shandwick Healthcare Weber Shandwick...
while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine is recruiting for Senior... for humanity. Learn more at . Role Summary We are seeking an experienced and visionary Senior Director to lead our data science...
while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine is recruiting for Senior... for humanity. Learn more at . Role Summary We are seeking an experienced and visionary Senior Director to lead our data science...
while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine is recruiting for Senior... for humanity. Learn more at . Role Summary We are seeking an experienced and visionary Senior Director to lead our data science...
conduct and ethical behavior; Medical Affairs SOPs and guidelines. In collaboration with direct manager, MSL will develop... for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison...
Job Description General Summary: The Senior Medical Science Liaison (Sr MSL) (Nephrology) for Povetacicept programs... of the Medical Affairs strategy and plan. The Sr MSL will engage HCPs in response to scientific educational and research...
Responsibilities Independent Project Management: Operate independently under the guidance of a senior manager... in knowledge of regulatory affairs, research ethics, and Responsible Conduct of Research (RCR) is preferred. Experience with basic...
with us? YOUR ROLE We are seeking a Finance Manager to support our global Trade, Government Affairs, and Tax teams in a uniquely cross... initiatives, providing insights and recommendations to senior leadership. Manage the global budget for Government Affairs...
-functional teams, including R&D, external manufacturing, quality control, vendor quality and regulatory affairs, to align... with Senior Executive leaders is crucial. Execution responsibilities include market analysis and due-diligence, RFx development...