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
$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...SuggestedTemporary workFlexible hours- Director of Regulatory Affairs The Director of Regulatory Affairs is accountable for the delivery... ...Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure... ...delivering global regulatory strategies and submissions. Demonstrated success in leading...SuggestedWork experience placement
$295k - $339k
...clinical science drug developer to serve as Medical Director in support of Revolution Medicines'... ...of clinical data supporting regulatory submissions (NDA, BLA, MAA). This role is uniquely... ...Biostatistics, Data Management, and Medical Writing to ensure clinical datasets,...SuggestedFull timeLocal area$298k - $350.6k
...Develop and participate in the writing and review of protocols,... ...reports and other clinical and regulatory documents Provide... ...final reports Act to provide medical oversight and safety monitoring... ...for global regulatory submissions Work closely and collaboratively...SuggestedFull time$339k - $357k
...The Division of Cardiology in the Department of Pediatrics at Stanford University seeks a... ...Professor 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...Suggested$346k - $397k
...science drug developer to serve as Senior Medical Director of Clinical Development in support of... ...and may extend to studies supporting regulatory submissions including Breakthrough-Therapy-... ...generation of trial design, protocol writing/ICF (writing or amendment), constructing...Full timeLocal area$165k - $220k
...of eye health in the future. The Director, Regulatory Affairs leads global regulatory strategy... ...interactions, ensure highquality submissions, and manage regulatory risk across the... ...may also be eligible to participate in medical, dental, vision insurance, disability...Temporary workWork visa$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$120.28k - $160.15k
...Education Lab seeks a full time Director of Operations,... ...team inputs, timelines, and submission processes. Lead budget... ...in industry standards and/or regulatory requirements. Ability to... ...• Occasionally stand/walk, writing by hand, use a telephone, lift...Hourly payFull timeContract workFixed term contractCasual workWork at office$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- ...pivotal clinical trials targeted for regulatory submission. This role will oversee and manages clinical... ...clinical trial sites, CROs, KOLs and medical societies; grow, develop and manage... ..., conducting literature review, writing clinical section for regulatory submission...Work at officeLocal areaWorldwideFlexible hours
$167.36k - $235.49k
...Executive Director, Institutional Research, Planning, and Effectiveness... ..., both orally and in writing, including the ability to synthesize... ...that may arise with your submission. You may also visit our "Applicant... ...package which includes medical coverage for employee and eligible...Full timeContract workTemporary workWork experience placementWork at officeLocal areaImmediate start- ...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
- ...clinic culture Monitor proper labeling, storage, transport, and chain-of-custody procedures for specimens in accordance with regulatory and laboratory requirements Compliance & Risk Management Ensure compliance with OSHA Bloodborne Pathogens Standard (29...Local area
$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$225k - $275k
...Who You Are You are an experienced regulatory affairs professional with expertise in... ...directly to the planning, preparation, and submission of high-quality regulatory submissions... ...) preferred. For Associate Director, we expect 7+ years of pharmaceutical/...Flexible hours- ...world leader in applying deep learning to medical image acquisition to enable faster,... ...the role: The Quality Engineering & Regulatory Affairs Manager will be part of the executive... ...documentation, validation script writing, IQ/OQ/PQ execution). General understanding...WorldwideShift work
$120k - $145k
...Job Description Job Description The Regulatory Affairs Manager is responsible for monitoring... ...have strong analytical and technical writing skills Experience: ~5+ years with... ...mental disability (including HIV/AIDS), medical condition (including cancer and genetic...Contract workWork experience placementWork at office- ...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
- ...Head Of Regulatory The Head of Regulatory is responsible for ensuring Hippocratic AI's life sciences platform meets the scientific, medical, and regulatory standards required to operate within life science environments. You will serve as the company's authoritative...
- ...compliance program and manage any day-to-day regulatory issues and communicate any compliance... ...policies and procedures including writing internal control investment memos for HQ... ...religion, physical or mental disability, medical condition, veteran status, marital status...
$162k - $186k
...Senior Manager, Regulatory Affairs Guilford, Connecticut or Palo... ...business priorities. Define submission plans, timelines, and resourcing... ...for Class I and Class II medical devices (preferably imaging/MRI... .... Ability to speak, write, and use all office equipment...Work at officeWork visaShift workNight shiftWeekend work3 days per week$200k - $269.8k
.... To learn more, visit The Associate Medical Director/Medical Director, will act as a key participant... ...cycle (Phase1-3) Participate in the writing and review of clinical protocols,... ...clinical operations, safety, biometrics, regulatory, medical writing, to achieve project...Full time$124.52k - $153.62k
...California seeks a Clinical Research Manager to oversee pioneering research in Parkinson's disease. The role requires operating within regulatory frameworks while managing clinical staff, budgets, and engaging with external stakeholders. Candidates need a Bachelor's degree...Full time- ...catchment area. The Senior Director, Clinical Operations leads the... ...staff to assure compliance with regulatory agencies, provide timely... ...management systems, electronic medical records, and clinical research... ...critical thinking skills, writing skills, communication skills...Temporary workWork at officeLocal area
$170k - $230k
...presentations and key reporting to the Board of Directors and Executive Team About you: ~ An... ...-blocks ~ Excellent presentation and writing skills and the ability to clearly... ...package including competitive compensation, Medical, Vision, and Dental coverage, generous...Work at officeRelocationHome officeFlexible hours- ...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...
- SCALIS in Palo Alto, California is seeking a Director of Global Regulatory Affairs to oversee permitting for large-scale drone light shows globally. The ideal candidate will manage regulatory compliance, coordinate approvals with aviation authorities, and ensure operations...Remote job
$255k - $265k
...best-in-class therapies to address unmet medical needs. Our culture fosters a place... ...skills. The Associate Medical Director is involved in the design, safety monitoring... ..., manuscripts, presentations, and regulatory submissions Contribute to design of the Clinical...Temporary workFlexible hours
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