Senior Medical Writer, Devices & Regulatory Submissions
ProPharma Group
ProPharma Group is seeking a senior medical writer to lead authoring and coordination of regulatory submissions and clinical study documents. You will collaborate with medical writing leadership, operations, and clients to deliver high-quality materials on time. The role emphasizes advanced knowledge of clinical research, FDA/regulatory guidelines, and strong communication and project management skills. A bachelor’s degree and 7+ years of experience in medical writing are required, with hybrid #J-18808-Ljbffr ProPharma Group
- ...empowers biotech, med device, and pharmaceutical organizations... ...domain expertise in regulatory sciences, clinical... ..., pharmacovigilance, medical information, and R&D... ..., NDA, BLA, MAA, eCTD submission level documents).*... ...less experienced medical writers, as necessary.*...RegulatoryMedical deviceContract workWork at officeRemote work
- ...Senior / Principal Scientist, QC and Analytical Development at LifeSprout Full... ...Integrity, Cross-functional Collaboration, Regulatory Submissions Description Description Senior... ...Hopkins University spinout. We are a medical device company creating revolutionary...SeniorRegulatoryMedical deviceFull timeImmediate startRemote workVisa sponsorship
- ...Inc. in Cupertino, CA, seeks a Senior Legal Counsel to support health products regulatory matters across global products... ...for health features and medical devices, collaborating with cross-functional... ...involves working with FDA submissions and international agencies, aligning...SeniorRegulatoryMedical device
$101.7k - $136.7k
## Senior Medical WriterApply: Remote (US): Full time: Posted Yesterday... ...fighting cancer.The Senior Medical Writer is responsible for writing,... ..., and formatting clinical regulatory documents that conform to... ...or international regulatory submission and internal document...SeniorRegulatoryHourly payFull timeContract workLocal areaRemote workShift work$84.37k - $120.53k
## Senior Medical WriterApply: Remote (US): Full time: Posted 2 Days Ago: JR104959**About... ...insurance**About the role**A Senior Medical Writer will create, research, edit and... ...applicable clinical documents for submission to regulatory authorities.* Prepare, develop, and finalize...SeniorRegulatoryFull timeContract workWork at officeRemote workFlexible hours$121.8k - $167.53k
...advances to patients who live with genetic diseases. ROLE: The Senior Medical Writer applies advanced documentation preparation and document... ...studies and reporting clinical study results for regulatory submissions and publications. RESPONSIBILITIES: Drafts and edits documents...SeniorRegulatoryFull timeFor contractorsWorldwideShift work$90k - $100k
...#LifeatRealChem. Position Summary The Senior Medical Writer serves as an integral part of the RealChemistry... ...and accuracy, and support Veeva submissions of all medical communication deliverables for client medical/legal/regulatory reviews by highlighting all relevant...SeniorRegulatoryFor contractorsWork experience placementCasual workWork at officeLocal areaRemote workNight shiftWeekend work2 days per week$130k - $196k
## Senior BiostatisticianApply: Hybrid: Dallas, Texas... ...cross-functionally with medical, product, engineering, data science, regulatory, and operations teams... ...health technology, medical device, pharmaceutical,... ...regulated environment (e.g. submissions involving the FDA or...SeniorRegulatoryMedical deviceFull time$92k - $138k
## Senior Regulatory Affairs SpecialistApply: Remote: Remote, US: Full time... ...strategies for new devices, new launch markets, and post... ...completing and maintaining product submissions and regulatory filings for clearance... ..., etc.), engineering, medical technology, regulatory...SeniorRegulatoryMedical deviceMinimum wageFull timeWork experience placementLocal areaRemote workWorldwide$142.77k - $161.9k
# Senior Design Quality EngineerReview the role, location... ...design quality, regulatory strategy, complaint handling... ...a small, fast-moving medical AI company. The... ...for a senior medical-device software design quality... ...letter-to-file or a new submission applies, and drive the...SeniorRegulatoryMedical deviceLive in- 4. Senior Design Quality Engineer# Senior Design Quality... ...quality system and regulatory record that hold it... ...Andreessen Horowitz, American Medical Association's venture... ...-to-file or a new submission applies, and drive the... ...on AI/ML-enabled devices, cybersecurity under Section...SeniorRegulatoryMedical deviceFor subcontractorLive in
- Senior R&D Technical Writer - Transfusion Country United States Shift 1st About the Position Introduction... ...IVD design history files and regulatory submissions. Strong understanding of Quality... ...within a Regulated Industry (medical device / pharma preferred.) Experience working...SeniorRegulatoryMedical deviceWork at officeRemote workWorldwideShift work
- ...and Responsibilities: Senior Director/Director, CMC/... ...Manufacturing and Controls, Regulatory CMC, and Quality... ...Organizations (CMOs or CDMOs) and Device area for DC/DV/DHF CMC regulatory submissions to CDER and CDRH and... ...products, and/or medical devices is required, as...SeniorRegulatoryMedical deviceFull timeContract workWorldwide
- OPEN Health in the United States seeks a Senior Medical Writer in Global Medical Affairs & Communications to craft scientifically accurate,... ...business proposals, with travel up to 20% and a strong emphasis on quality and regulatory awareness. #J-18808-Ljbffr OPEN Health GroupSeniorRegulatory
- LifeSprout is seeking a Senior/Principal Scientist to lead QC and analytical development for biomaterials and medical devices. You will design, validate, and maintain test methods... ...requires strong hands-on method development, regulatory-style documentation, and cross-...SeniorRegulatoryMedical deviceRemote job
- Syneos Health, Inc. is seeking a Principal Medical Writer to lead complex medical writing deliverables for multiple studies. The role supports... ...work from the USA, with a focus on publication planning and regulatory quality across therapeutic areas. The ideal candidate will...SeniorRegulatoryRemote job
- Real Chemistry is seeking a Senior Medical Writer to support the Medical Communications division by translating complex science into clear clinical... ..., mentorship of junior writers, and strict adherence to regulatory standards while delivering high-quality materials for...SeniorRegulatory
- Avanos Medical, Inc. is seeking a Senior Software Engineer for its Alpharetta, GA-based R&D team. You will review... ...lifecycle activities for connected medical devices. You will collaborate with Systems Engineering, Quality, Regulatory, and external CDMOs, and support design...SeniorRegulatoryMedical device
- Senior Medical Writer - Global Medical Affairs & Communications By continuing to use and navigate this website, you are agreeing to the use of... ...& product positioning of pharmaceutical, biotech & medical device clients. Level of experience and ability to effectively partner...SeniorMedical deviceWorldwide
- ...and drive quality system improvements for in-vitro diagnostic devices. Responsibilities include audits, CAPA management, and collaboration... ...with cross-functional teams to ensure product quality and regulatory readiness across the lifecycle. #J-18808-Ljbffr Werfenlife SA...SeniorRegulatoryMedical device
- ...experienced Software Development Manager to lead embedded software for medical devices and drug delivery applications. You will manage a team through full development lifecycle, ensure regulatory alignment, and collaborate with cross-functional teams across engineering...SeniorRegulatoryMedical device
- ...Overview Merrimack Manufacturing is a medical device manufacturer located in the Manchester... ...to life. Position Summary The Senior Supplier Quality Engineer (Sr. SQE) is... ...capable of consistently meeting quality, regulatory, and performance expectations. This role...SeniorRegulatoryMedical deviceContract workRemote work
$75k - $112.5k
...clinical, and societal value of creative medical treatments to payers, providers,... ...around the world. Position Summary: The Senior Medical Writer is responsible for developing and writing... ..., as necessary Attend medical, legal, regulatory review meetings and participate, as...SeniorRegulatoryRemote work- ...Description POSITION SUMMARY: The Senior Product Development Engineer leads... ...commercialization efforts to launch innovative medical devices in the foot and ankle industry. This... ...Work collaboratively with Quality, Regulatory, Operations, and Marketing personnel to...SeniorRegulatoryMedical deviceCasual work
- MiniMed seeks a Senior Software Quality Engineer to lead quality activities for digital... .../web/cloud). You’ll work with R&D, Regulatory, Marketing and Operations to drive a robust... ...in Agile/Waterfall/DevOps within the medical device industry. Hybrid role in Northridge, CA...SeniorRegulatoryMedical device
- Orthogonal is a development and consulting firm that focuses on SaMD and connected medical devices. We seek a Senior Quality and Regulatory Consultant to translate risk and business goals into a right-sized plan and work across a portfolio of engagements rather than being...SeniorRegulatoryMedical deviceRemote job
$133k - $212k
**Senior Manager, Scientific Communications**The Senior... ..., presentations, and regulatory documents aligned with... ...content.* Oversee submission, review, approval, and... ...for evidence capture, device and system performance... ...a master’s degree in medical or clinical Affairs within...SeniorRegulatoryMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...onsite role will guide architecture and the evolution of a new medical technology platform and the RETeval portfolio. You will design... ..., and collaborate with hardware, clinical, quality, and regulatory teams to bring products from concept through commercialization...SeniorRegulatoryMedical device
- ...R&D team. The role focuses on verification and validation of medical device software, coordinating cross-functional efforts and leading a... ...automation skills, test strategy leadership, and adherence to regulatory standards, with a hybrid work model in Maple Grove, MN. #J-1...SeniorRegulatoryMedical device
$130k - $170k
...Description BryceTech is seeking a Senior Acquisition Specialist to... ...Acquisition Executive for Medical Products (PAE MP). This... ...medical product development and regulatory requirements Responsibilities... ...and blood products, medical devices, and other regulated medical...SeniorRegulatoryMedical deviceContract workTemporary workFor contractors
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