- J&J Family of Companies (Boston, MA)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory ... people can reach their potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a highly experienced … more
- Takeda Pharmaceuticals (Boston, MA)
- … response documents and key components of regulatory submissions. + The Associate Director , Medical Writing is seen as an expert in medical ... therapies to patients worldwide. Join Takeda as a Associate Director Medical Writing where you...documents. Collaborate with all Takeda regions to ensure a medical writing regulatory document strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology ... contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- J&J Family of Companies (Boston, MA)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory ... Authorities. + Provides technical expertise and technical input in the preparation and writing (as applicable) of regulatory dossiers for submission to Health… more
- Pfizer (Boston, MA)
- …industry standards, new technology, and new processes that impact Medical Writing . + Proficiency with global regulatory guidance (especially ICH, FDA, and ... anticipated delays, information gaps, or potential shortcomings in quality. + Communicates Medical Writing 's position on resource and timeline needs for assigned… more
- Novo Nordisk (Lexington, MA)
- … Medical /Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing , Program Management, CMC and Regulatory Affairs teams. Will ... ready to make a difference? The Position The International Medical Director serves as a subject matter...Work with, Clinical Operations, Non-Clinical Research, Medical Writing , Program Management, CMC and Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **About the role:** Join Takeda as an Executive Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You ... with and influences other cross-functional departments (eg Development Operations, Regulatory Affairs, Medical Affairs, Data Science Institute, Clinical… more
- J&J Family of Companies (Cambridge, MA)
- … safety, biostatistics, regulatory affairs, clinical supplies unit, medical writing , clinical pharmacology, legal, finance, quality assurance, strategy ... Medical Director , Clinical Development - Psychosis... Regulatory Affairs in the development of drug regulatory strategies + Executes medical -related consultation for… more
- Takeda Pharmaceuticals (Boston, MA)
- …and plasma-oriented therapies for patients with serious, complex diseases. The Medical Director - Hematology, Neuroimunology & Specialty Care (HNSC) ... and/or Transplant medicine to clinical development, taking into consideration the medical , scientific, regulatory and commercial perspectives. They will lead… more
- State of Massachusetts (Boston, MA)
- …services. As Deputy Commissioner for Clinical & Professional Services**and**serving as State Medical Director , you will establish and oversee a proactive system ... DMH serves the Commonwealth as the State's Mental Health Authority. The State Medical Director is responsible for monitoring performance trends in the MH… more
- Globus Medical, Inc. (Methuen, MA)
- …CAPA, MDR, NCMR, and all relevant compliance activities + Work closely with Regulatory Affairs in planning, coordination, writing , and execution of 510(k), IDE ... enabling technology division is searching for an enthusiastic Senior Director of Product Development to lead our navigation and...+ Represent the company in a professional manner to regulatory bodies, Medical Board of Directors, Clinical… more
- Organon & Co. (Boston, MA)
- …support the approved early development plans. The TMED Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction ... **The** **Position** **This position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will be responsible for… more
- Cardinal Health (Boston, MA)
- …(CMC) Development + Nonclinical Development and Consulting + Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + ... & Filing + Quality Review Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + … more
- Dana-Farber Cancer Institute (Brighton, MA)
- In collaboration with the Senior Director of Network Operations, site Medical Director and Nurse Director , the Operations Director will oversee daily ... Bank, Food Services, Radiation Oncology, etc. + _DFCI:_ VP, Network Operations; Medical Director , Network; VP, Network Nursing/Patient Care Services; Senior … more
- KPMG (Boston, MA)
- …practice and people development initiatives including contributing to industry and regulatory publications, writing professional articles, and speaking about ... **Business Title:** Director , Consumer Compliance **Requisition Number:** 118205 - 40...and solutions by addressing emerging compliance risks resulting from regulatory change, business transformation, and industry disruption + Evaluate… more
- Takeda Pharmaceuticals (Boston, MA)
- …publications systems for reporting metrics to meet stakeholder needs + Manage medical writing agency, including oversight on execution of publications plans ... applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs, and Medical Affairs to fully understand development… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism ... in **programs focused on respiratory disease.** + The Senior Director of Clinical Research will be responsible for phase...KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory , Operations, etc.). * Develop the primary and secondary… more
- Fujifilm (Boston, MA)
- **Overview** As the Associate Director of Biosafety, you will serve as the Corporate Biosafety Officer (BSO) and provide expertise in biorisk management, ... and safety. This position will report to the Global Director , Biosafety and Toxicology, and sit under the global...Toxicology, and sit under the global quality leadership group ( Regulatory , IT, Safety, QA, and QC). **External US** The… more
- Boston College (Chestnut Hill, MA)
- …in excess of $3.5 billion. **Job Description** Under the direction of the Director of Financial Aid, this position oversees all financial aid systems, including the ... Services Information Systems department as well as system vendors to ensure regulatory changes are implemented in a timely and successful manner. Shares… more
- Avania (Boston, MA)
- …and complex range of service solutions including Analytics, Clinical Operations/Trials, Medical writing , strategic consulting, regulatory , quality, market ... Avania are hiring - Director , Business Development - Full Service CRO - Medical Devices - Boston, MA Expansive growth in our Business Development team creates… more