Senior Medical Writer: Regulatory Submissions Expert
MMS
MMS is a Denver-based, data-focused CRO providing regulatory submission support for pharma, biotech and medical device trials. The Medical Writer will interpret literature, prepare regulatory documents and manage writing projects in a fast-paced environment. Ideal candidates have 3+ years in pharmaceutical regulatory writing, strong MS Word/PowerPoint skills, and experience leading teams under tight timelines. Strong communication and knowledge of ICH guidelines are a plus. #J-18808-Ljbffr MMS
- ...pharmaceutical, biotech, and medical device industries with a... ...approach to complex trial data and regulatory submission challenges. With a global... ...supervision, the Medical Writer will critically evaluate, analyze... ...regulatory documents Expert proficiency with client templates...SeniorRegulatoryRemote jobWorldwide
- Stryker is seeking a Senior Staff Medical Writer for its Endoscopy division. Based remotely within the... ...complex clinical evidence into regulatory and scientific documents across the... ...Marketing to support CERs, PMCF, and submission-ready materials while mentoring junior...SeniorRegulatoryRemote job
$110.1k - $183.4k
...Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division... ...that supports global regulatory compliance and market access... ...performance sources into submission-ready regulatory documents... ...(PMCF) documentation. Expert knowledge of MEDDEV 2.7/1...SeniorRegulatoryFull timeRemote work$150k - $195k
Travere Therapeutics is seeking an Associate Director, Medical Writing to oversee regulatory submissions and ensure compliance with medical writing standards. You will lead medical writing projects and collaborate with cross-functional teams to deliver high-quality documents...SeniorRegulatoryRemote work- MMS Holdings Inc is seeking an experienced Medical Writer based in Denver, Colorado. The role involves writing and editing clinical documents... ..., and mentoring team members. A strong background in regulatory writing and at least 3 years of experience in the pharmaceutical...SeniorRegulatoryRemote job
- ...mortgage servicer focused on service and investor guidelines. The Senior Default Claims Specialist will manage FHA/VA/USDA/MI, Freddie... ..., strong communication, and the ability to prioritize tasks to meet SLAs and regulatory changes. #J-18808-Ljbffr Cornerstone CapitalSeniorRegulatory
- EVERSANA is seeking a Medical Science Liaison (MSL/Sr. MSL) to serve as a field-based scientific expert in cholangiocarcinoma and hepatocellular carcinoma. You will engage... ...while ensuring compliance with SOPs and regulatory guidelines. The role requires advanced scientific...SeniorRegulatory
- Unified Women’s Healthcare is seeking a Senior Counsel Employment to provide legal counsel on a broad range of labor and employment matters... ...with HR, business leaders, and senior management to ensure regulatory compliance and mitigate risk across multiple states. You will...SeniorRegulatory
- ...Stryker is seeking a Senior Staff Medical Writer for the Endoscopy Division, based remotely within... ...United States. The role partners with Regulatory Affairs, Clinical Affairs, Quality,... ...literature, and supporting market access through regulatory submissions. #J-18808-Ljbffr...RegulatoryRemote work
- ...seeks an Associate Director of Academic Compliance to drive regulatory readiness and support location and program leaders. The role... ...Responsibilities include coordinating advisory boards, preparing regulatory submissions, and training university staff across locations. #J-18808-...SeniorRegulatory
- Responsibilities Provide regulatory leadership and oversight for ongoing and planned in vivo... ...regulatory filings (IND/CTA/BLA/MAA submissions). Serve as the primary point of contact... ...relevant experience in regulatory affairs for Senior Director level. Minimum of 15/18/18+...SeniorRegulatory
- ...programming across development programs and guide the Biometrics team. You will oversee external vendors and drive standards for regulatory submissions. This role requires strong SAS expertise, CDISC SDTM/ADaM, Define.XML, and experience with submissions; leadership...SeniorRegulatoryRemote job
$133.71k - $180.9k
...examinations, including the research, formulation, and timely submission of responses to Information Document Requests (IDRs) and... ...monitoring, analyze tax developments, and synthesize regulatory impacts for senior leadershipSkills, Experience and RequirementsCore Skills...SeniorRegulatoryLocal areaFlexible hours$40k - $100k
...in Denver, CO. This role involves collecting documents from research sites, maintaining trial documentation, and organizing regulatory submissions. The ideal candidate should have a Bachelor's degree in Life Sciences and at least 3 years' experience in clinical research...SeniorRegulatoryContract workFlexible hours$138.7k - $215.1k
The Senior Manager Regulatory Affairs provides senior-level leadership for global regulatory strategy and execution for new, modified, and marketed CONMED medical devices. Directs regulatory submission strategy, agency engagement, labeling and claims review, product lifecycle...SeniorRegulatoryWork experience placementWork at office- A clinical laboratory is seeking a Regulatory Affairs specialist in Denver, Colorado, with at least 8 years of experience. The role involves preparing documents for regulatory submissions, engaging with FDA and cross-functional teams, and reviewing promotional materials...Regulatory
$230k
Nova Pneuma in Colorado is seeking a Senior Regulatory Affairs Manager to oversee regulatory strategies and submissions for product candidates. The ideal candidate will have a bachelor’s degree in a scientific discipline and over 10 years of relevant regulatory experience...Regulatory$72.35k - $103.4k
...global import and export regulations. The Senior Global Logistics & Trade Compliance... ...managing tariff programs, and interpreting regulatory shifts. Partnering across sourcing, procurement... ...from your application documents before submission and throughout our application process....SeniorRegulatoryLocal areaFlexible hoursShift work$96.25k - $137.5k
...DISH.Job Duties and ResponsibilitiesThe Senior HR Business Partner has foundational HR... ...design Provide expertise in technical and regulatory aspects of employment, including hiring,... ...from your application documents before submission and throughout our application process.EchoStar...SeniorRegulatoryHourly payLocal areaFlexible hours$118k - $130k
...to work in a collaborative environment? As an experienced Regulatory Reporting Senior Consultant, you will have the ability to share new ideas... ...responsible for overseeing the preparation, review, and submission of regulatory reports within the defined scope of 40 Act...SeniorRegulatoryLocal areaVisa sponsorship- ...programs and standard work for environmental report management and submission Lead global facility EH&S reviews to detect hazards and... ...Corrective Action Implementation Risk Management Due Diligence Regulatory Knowledge Environmental Reporting Process Leadership...SeniorRegulatoryRelocation
$156k - $241k
...cost-effective manner.As a Wastewater Treatment Subject Matter Expert, you will be responsible for mentoring, quality, technical excellence... ...experience in wastewater treatment, wastewater modeling, and regulatory compliance.Experience in leading and mentoring others....RegulatoryFull timeWork at officeLocal areaRemote workFlexible hours$151k - $215k
...everything we do. As part of our Medical Affairs team, you'll foster... ...inspiring journey. The Senior Principal Biostatistician (... ...clinical trial designs to regulatory submissions while applying scientific rigor... ...stakeholders and external experts/KOLs Demonstrated leadership...SeniorRegulatoryFull timeRemote work$96.25k - $137.5k
...person interview.This role bridges the gap between high-level regulatory requirements and day-to-day data/AI projects and operations. Direct... ...of school/graduation from your application documents before submission and throughout our application process.EchoStar will provide...SeniorRegulatoryLocal areaFlexible hours$120k - $150k
...Senior Design Manager/Document ControllerFleet Data Centers designs... ...with specifications, regulatory requirements, and industry best... ...project alignment.Monitor document submission and approval timelines,... ...including 100% employer-covered medical, dental, and vision insurance...SeniorRegulatoryWork at officeRemote work$85k - $95k
LivaNova is seeking a Regulatory and Clinical Specialist to support clinical evaluations and regulatory submissions for active implantable medical devices. The role entails preparing evaluation plans, managing submissions, and collaborating across teams to ensure compliance...RegulatoryRemote jobFlexible hours- ...consistency and compliance with legal and regulatory requirements. Provide proactive process... ...case information as required to support submission. Assist in performing regulatory... ...general financial accounting or analysis for Senior level. Note: Candidates with a Master's...SeniorRegulatoryWork at office
$85k - $95k
...GHJ is looking for a Senior Specialist, Payroll... ...GHJ’s subject matter expert for Dayforce Payroll and... ...reconciliation, final submission and post-payroll validation... ...compensation related regulatory requirements.... ...childbirth or related medical conditions), sexual orientation...SeniorRegulatoryFull timeLocal areaWorldwideDay shift- ...Job Description EisnerAmper is seeking a Senior Consultant – FEMA in our Government... ...funding opportunities and development and submission of proposals. May be required to occasionally... .... Keeping up with ever-changing regulatory requirements, Governmental Accounting Standards...SeniorRegulatoryWork at officeLocal area
$72.35k - $110k
...precision in estimated tax reporting. The Senior Tax Accountant will solve data... ...and compliant tax posture in a fast-paced regulatory environment.The ideal candidate is highly... ...from your application documents before submission and throughout our application process.EchoStar...SeniorRegulatoryLocal areaFlexible hours
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