Cardiology Medical Writing Director — Regulatory Submissions
$285k - $345kPiper Companies
A biotechnology firm in Palo Alto is seeking an Executive Director of Medical Writing to oversee the Cardiology medical writing activities, ensuring high-quality documents that align with clinical and regulatory objectives. The ideal candidate will have over 12 years of experience in regulatory medical writing within biotechnology or pharmaceuticals, demonstrating leadership and excellent communication skills. A comprehensive benefits package, including medical and dental insurance, is offered alongside a competitive salary range of $285,000 to $345,000. #J-18808-Ljbffr Piper Companies
- Rezolute, based in Redwood City, is searching for a Director Global Regulatory Lead to manage regulatory strategies for product development.... ...healthcare. Responsibilities include leading regulatory submissions and developing strategic plans. The position offers a competitive...Suggested
- ...Medical DirectorRedwood City, California, United StatesRevolution... ...to serve as Medical Director in support of Revolution Medicines... ...clinical data supporting regulatory submissions (NDA, BLA, MAA). This role... ...Data Management, and Medical Writing to ensure clinical datasets...Suggested
$339k - $357k
The Division of Cardiology in the Department of Pediatrics at Stanford University seeks a board... ...or Professor in the University Medical Line or Clinician Educator Line. We are... ...heart transplantation, to serve as Medical Director of the Pediatric Advanced Cardiac Therapies...Suggested- ...We sit at the intersection of clinical cardiology, hardware, software, and data, building... ...the day-to-day operational, clinical, and regulatory functions of our Independent Diagnostic... ...ensure all diagnostic tests are ordered in writing by the treating physician and that...SuggestedFull timeFor contractorsWork at officeLocal areaRemote workShift work
- ...the intersection of regulated medical device development and fast-... ...meeting, an FDA pre-submission discussion, or a cross-functional... ...enrollment, data quality, and regulatory timelines. Lead site... ...& Experience Experience in cardiology, electrophysiology, or cardiovascular...SuggestedSeasonal workRemote workFlexible hours
$175k - $236.5k
...operations teams, and Legal and Compliance colleagues to provide regulatory guidance on new and existing products. Translate complex... ...functional stakeholders. Excellent communication, interpersonal, and writing skills, with strong organizational skills and a keen attention...$114k - $228k
...and products in diagnostics, medical devices, nutritionals and branded... ...and peripheral stents.This **Regulatory Affairs Manager** position is... ...clinical strategy and submission activities* Anticipate regulatory... ...communicate verbally and in writing, prepare, and negotiate both...Work experience placementShift work$194k - $199k
...Associate Director, Regulatory CMC Palo Alto, CA (US) Summit Therapeutics Inc. is a biopharmaceutical... ...of life, and resolving serious unmet medical needs. At Summit, we believe in... ...and oversee preparation of regulatory submissions in collaboration with other...Work at office$212k - $318k
.../Responsibilities The Associate Medical Director / Global Safety Physician is responsible... ...organization as well as with external Regulatory Authorities. This individual, under... ...MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests...Contract workWork experience placementRemote workWorldwideFlexible hours$185k - $205k
...therapeutics that address significant unmet medical needs? Then Ascendis Pharma is... ...looking to hire an experienced Associate Director, Regulatory Affairs Clinical Strategy to join our... ...of organized and scientifically valid submissions. Provides expertise in translating regulatory...Temporary workFlexible hours$66.52 - $88.14 per hour
...budget, make financial projections and write reports. Ability to ensure project compliance... ...Knowledge of local, state and federal regulatory requirements related to areas of... ...origin, political beliefs, marital status, medical condition, genetic information, veteran...Hourly payContract workFor contractorsWork experience placementLocal areaRemote work- ...outcomes research studies to help regulatory approvals and key strategic... ...reports), organizing IRB/EC submissions with follow-thorough to... ...appraise scientific literature and write clinical summaries to assist... ..., helping and managing medical device trials Significant knowledge...Interim roleLocal areaRemote workFlexible hoursShift work
- ...entertainment and technology on a global stage. As our operations continue to expand across continents, we are seeking a Director of Global Regulatory Affairs to lead and coordinate the complex regulatory approvals required to safely operate drone shows around the world....Local area
- ...Primary Function of Position This Director role leads the enterprise level Multiport Business Unit (MP-BU) Regulatory Affairs (RA) teams supporting the total product... ...first, always. Oversee premarket regulatory submissions for USA and CA, including registrations, 51...Local areaWorldwideFlexible hours
$120k - $145k
...Requisition #: REGUL011881 Description The Regulatory Affairs Manager is responsible for... ...Must have strong analytical and technical writing skills Experience 5+ years with Bachelor... ...mental disability (including HIV/AIDS), medical condition (including cancer and genetic...Full timeContract workWork experience placementWork at office$73.68 - $110.52 per hour
...directly with service line leaders, medical staff (e.g. Co-Management),... .../other guidelines and regulatory specifications to include Joint... ...physician leadership, and department directors. Works closely with clinical... ...Plan verbally and in writing as it applies to department.)...Work at officeShift work$159k - $231k
...interaction design, visual design, user research, writing). Preferred qualifications Experience... ...interfaces and collaborating with medical experts, doctors, and coaches. We are... ...approval by the Alphabet Inc. board of directors or its delegate, the terms of the relevant...For contractorsFlexible hoursShift work$115k - $125k
...motivated Safety & Compliance Supervisor to oversee safety programs, regulatory compliance, and employee training for our transfer station,... ...Strong ability to communicate effectively, both orally and in writing. · Ability to quickly learn department policies, procedures,...Full time- ...specified. About the Role The Head of Regulatory Affairs is responsible for leading and... ...trials for pharmaceuticals, biologics, and medical devices, and (b) AI‑driven SaMD... ...and support regulatory strategies and submissions for AI‑enabled SaMD products, including...Work at office
- ...submitting renewals; compiling and submitting regulatory reports; scheduling and running meetings... ...those relating to DBAs Manage Director/Officer changes, including scheduling fingerprinting... ..., communication, interpersonal and writing skills are a must Benefits Intuit...
$180k - $250k
...efficiency meets empathy in one of Silicon Valley's most desirable locations. About This Role Join us as our new Medical Director at Midtown Veterinary Hospital , where you'll combine clinical excellence with strategic leadership. You'll serve as the...Relocation package- ...Position: Executive Director, Regulatory Affairs CMC Location: Redwood City, CA Job Id: 270-1156 # of Openings: 1 Allakos Inc. is a dynamic... ...: Creates and implements CMC regulatory strategies for CTA submissions and marketing applications. This role will have accountability...
$25k
...****@*****.*** Overview OB-GYN Hospitalist Medical Director Sequoia Hospital | Redwood City, CA Responsibilities... ...providers Ensure compliance with clinical standards, regulatory requirements, and best practices Clinical Practice Highlights...Full timeTemporary workPart timeImmediate startRelocation packageFlexible hoursShift work$142.6k - $261.5k
...verbal communication, presentation, client service and technical writing skills. Ability and comfort level researching client... ...and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range...Summer holidayFlexible hours$142.6k - $261.5k
...verbal communication, presentation, client service and technical writing skills. Knowledge of leading practices, benchmarking, peer... ...and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range...Summer holidayFlexible hours$304k - $423k
Director, Regulatory Affairs, Global Investigations and Enforcement Competition corporate_fare Google place Mountain View, CA, USA bar_chart Director+ Required Qualifications 15 years of experience in litigation, regulatory investigations, and enforcement. Admitted...- Google Inc. is seeking a Director of Regulatory Affairs in Mountain View, CA, to lead a team focusing on regulatory scrutiny, enforcement actions, and mitigation of risk. The role encompasses establishing essential policies and processes for managing complex legal matters...
- Pharma Search Partners, Inc. is seeking a Senior Director/Director of Biostatistics to lead statistical efforts in oncology drug development... ...in oncology. Strong knowledge of statistical methods and regulatory guidelines is essential. #J-18808-Ljbffr Pharma Search...
$211k - $264k
...signaling pathway. The Opportunity: The Director, Global CMC Regulatory is a strategic leadership role... ...portfolio. Oversee the preparation and submission of high‑quality CMC dossiers for... ...ancestry, age, disability, marital status, medical condition, and veteran status. Base...Worldwide$125k - $150k
...Early - Diagnose Early is bringing non-invasive biometric and medical testing to the world. We improve and lengthen life through the... ...development cycles and release management processes Excellent writing skills and willingness to write documentation An...
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