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
- 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
$195k - $240k
Element Science, Inc. is a medical device and digital health company... ..., and Invus Opportunities. DIRECTOR OF REGULATORY AFFAIRS SUMMARY OF ROLE: We... ...regulatory strategy and submissions for our products, managing... ...of effective regulatory writing fundamentals and ability to...SuggestedTemporary workLocal areaVisa sponsorshipWork visaRelocation packageFlexible hours$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...$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$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$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...$250k - $275k
...Evommune is seeking a highly motivated and experienced Senior Director of Regulatory Affairs to lead global regulatory strategy and operations... ...developing and executing regulatory strategies, overseeing submission activities (INDs, CTAs, NDAs/BLAs/MAAs), and partnering...Work at officeRemote work2 days per week3 days per week$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$66.52 - $88.14 per hour
...problems. Under the direction of the Laboratory Directors and the Laboratory Manager, investigates, writes, and implements technical procedures and policies... ...service needs. ~ Under the guidance of the section Medical director, develops and implements department...Hourly payTraineeshipWork experience placementNight shift$105.1k - $192.6k
...benefits and consequences using Microsoft Excel, PowerBI or Alteryx. Writing tax technical memos to succinctly articulate issues,... ...and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range...Work experience placementSummer holidayFlexible hours- Corcept Therapeutics in Redwood City, California is seeking a Director of Regulatory Affairs CMC to lead the preparation of CMC regulatory documents from pre‑IND to marketing authorization across multiple therapeutic areas. This hybrid role requires oversight of a high...
$213k - $240k
...culture. Job Title: Director, Clinical Operations... ...circumstances (e.g., regulatory changes, unexpected site... ...required in a scientific/medical field preferred A... ..., SOP and Study Plans writing, CAPA preparation, and... ...closure Experience with a submission-ready eTMF, regulatory...Full timeContract workFlexible hours3 days per week$150k - $160.5k
...animal staff Strong knowledge of regulatory requirements and inspection... ..., and technical writing skills, with strong attention... ...including comprehensive health (medical, dental, and vision) insurance... ...Note to External Recruiters Submission of unsolicited resumes prior...Contract workWork at officeLocal area$256k - $384k
...organization as well as with external Regulatory Authorities. This individual will work... ...(MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests... ...product labeling. Support review of medical/scientific literature to identify...Remote workWorldwideFlexible hours- ...Director, Regulatory CMC (Hybrid – San Francisco Bay Area) We are partnering with a well-funded, clinical-stage biotechnology company... ...regulatory expectations and successful IND/CTA, BLA, and NDA submissions. This is a hybrid role based in the San Francisco Bay...
$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$250k - $275k
...biopharmaceutical company located in Palo Alto is seeking a Senior Director of Regulatory Affairs. This role involves leading the regulatory strategy for investigational products, managing submissions and interactions with regulatory authorities. Candidates should have...$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
- ...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...
- ...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
- SCALIS, located in Palo Alto, California, is seeking a Director of Global Regulatory Affairs to oversee the permitting strategy for drone light shows. The role involves managing compliance with aviation regulations globally, coordinating with internal teams and external...Remote jobFlexible hours
- Director of Global Regulatory Affairs At Nova Sky Stories, we create large-scale drone light shows that redefine entertainment and technology on a... ...and best practices. Work with C++ and Qt/QML codebases to write effective, maintainable test code. Ensure test coverage and...Local areaRemote workFlexible hoursNight shiftWeekend work
$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$238.9k - $281.1k
Director, Regulatory Affairs CMC Redwood City, California, United States Lead the preparation of CMC regulatory documents from pre‑IND to marketing authorization submissions across multiple therapeutic areas, molecules, and regions. This hybrid role will be on‑site three...Full time3 days per week- ...Description Primary Function of Position This Director role leads the enterprise level Multiport Business Unit (MP-BU) Regulatory Affairs (RA) teams supporting the total... ...first, always. Oversee premarket regulatory submissions for USA and CA, including registrations, 51...Local area
$87.4k - $253k
...driven revenue growth strategy. Minimum 5 years of experience writing business cases. Minimum 2 years of experience leading or... ...Accenture offers a market competitive suite of benefits including medical, dental, vision, life, and long-term disability coverage, a 401...Live inWork at officeLocal area
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