Global Regulatory Submissions Lead - Princeton - Ascendis Pharma A/S

We are seeking a Manager, Medical Writing to play a hands-on role in the development of regulatory and clinical documentation for an oncology-focused pipeline. · ...

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds... · ...

Joining us is a chance to do important work that creates change and shapes the future of healthcare. · Thinking differently is what we do best. To us, change equals opportunity. · Every day our colleagues are challenging what's possible and making headway to innovate new treatmen ...

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the ...

We are seeking a Manager, Medical Writing to play a hands-on role in the development of regulatory and clinical documentation for an oncology-focused pipeline. This position will have significant responsibility for regulatory submissions, including Module 2 summaries, and will pa ...

We are seeking an experienced Drug Development Program Manager to support global R&D drug development assets across the full lifecycle. · Partner closely with Global Program Leads to drive asset-level strategy, planning, and execution · Own lifecycle management (LCM) planning for ...

We are dedicated to building extraordinary futures by developing antibody products and groundbreaking medicines. · We strive to create, champion, and maintain a global workplace where individuals' unique contributions are valued · Our people are compassionate candid purposeful in ...

About Us  · Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. · It is Kardigan's mission to develop multiple targeted treatments in parallel that bring people with cardiovascular d ...

We are looking for a Director to join the Drug Substance team within the Technical Operations department at Kardigan Bio. · This role will support clinical and commercial product lifecycle management including authoring technical assessments monitoring process performance continu ...

We are seeking a Manager or Senior Manager, · Pharmacovigilance (PV) Operations to support the Senior Director of PV · Operations in key areas of the pharmacovigilance function.SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic ind ...

Changing lives. Building Careers. · To us, change equals opportunity. · ...

SystImmune seeks an experienced Director/Senior Director of Clinical Development to lead clinical trials and collaborate across functions.SystImmune is a leading biopharmaceutical company developing innovative cancer treatments. · ...

Kardigan Bio is seeking a strategic and hands-on analytical leader to join our Analytical Development team within Technical Operations. · In this role, you will lead analytical development for small molecules and/or oligonucleotide programs, supporting late-phase development thro ...

We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. · Pursuing an undergraduate or graduate degree with a 2027 graduation date from an accredited U.S. based University in any Science discipline. · ...

The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics. · Drive the development and execution of innovative global regulatory strategies. · Serve as the regulatory lead on the Translational Medicine CLIA Laborat ...

The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, · We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work · ...

The Director of Global HEOR - Oncology is responsible for planning and leading the health economics and outcomes research (HEOR) evidence generation strategy, · Independently lead the strategy, design and execution of robust evidence generation of HEOR studies ...

The Director, Clinical Scientist is responsible for leading/contributing to study design and execution of clinical studies in hematology/oncology. · MS (or equivalent) required; PhD, PharmD, or MD preferred. · Minimum of 5+ years overall related experience with PhD or like degree ...

The Assistant Global Labeling Lead (AGLL) will support Freyr's Client by assisting the Global Labeling Lead (GLL) in authoring, reviewing, and maintaining key labeling documents such as Core Company Data Sheets (CCDS), US Prescribing Information (USPI), and local labeling across ...

SystImmune is seeking an experienced Director/Senior Director of Clinical Development to lead the direction, planning, execution and interpretation of clinical trials within the Clinical Development program. · Lead the design and implementation of clinical development programs gr ...

The Regulatory Affairs Operations Specialist is responsible for supporting Sandoz's regulatory operations with a strong focus on regulatory submissions and publishing activities. · This position supports registration data management, · product life cycle activities, · business pr ...