Senior Medical Writer - Immunology Regulatory Submissions
argenx SE
argenx SE is seeking a Senior Medical Writer to author and manage contributions for regulatory submissions, ensuring compliance with medical writing standards. The successful candidate will have a strong background in pharma or biotech, with at least 3 years of clinical/regulatory medical writing experience. The position offers a competitive salary and a comprehensive benefits package. Join us in transforming immunology for patients with severe autoimmune diseases. We value diversity and inclusion in our hiring process. #J-18808-Ljbffr
$128k - $176k
...leading biotech company is looking for a Senior Medical Writer to provide support for developing complex clinical and regulatory documents. The ideal candidate will have a... ...authoring and managing content for regulatory submissions and ensuring quality standards are met....SeniorRegulatoryRemote work- ...A leading biopharmaceutical company is looking for a Senior Medical Writer to develop clinical documents for regulatory submissions. The candidate will manage medical writing projects, lead timelines, and collaborate with cross-functional teams. Key qualifications include...SeniorRegulatoryRemote work
$128k - $176k
...Senior Medical Writer Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing... ...manage SME contribution to develop content for regulatory submissions that is well‑organized, consistent, accurate, and...SeniorRegulatoryTemporary work- ...Overview Senior Medical Writer (Remote) at MMS. Join to apply for the Senior Medical Writer (Remote) role at MMS. About MMS: MMS is a... ...a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents...SeniorRegulatoryFull timeRemote work
- ...healthcare intelligence firm is seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will... ...medical writing experience, particularly in regulatory submissions. This role offers a competitive salary and a...RegulatoryRemote workFlexible hours
- ...A global clinical research organization is seeking a highly organized Senior Regulatory Affairs Associate to coordinate regulatory submissions across regions. The successful candidate will manage submission activities, ensuring timely and compliant filings that support...SeniorRegulatory
$101.8k - $152.6k
...Precision Medicine Group is seeking a Medical Writer to lead the development of high-quality clinical study documents. Responsibilities... ...and QC review of critical clinical documents compliant with regulatory guidelines (ICH, FDA). The candidate must have a BS degree and...SeniorRegulatory- ...We are seeking a highly organized and detail-oriented Senior Regulatory Affairs Associate to serve as a Regional Submission Coordinator . This is a key operational role responsible for coordinating all activities required to deliver regulatory submissions across assigned...SeniorRegulatoryWork at officeLocal area
- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...communication with teams. Benefits include comprehensive medical coverage, 401(k) match, stock incentives, and generous PTO...SeniorRegulatoryRemote work
- ...Precision for Medicine is seeking a Senior Medical Writer responsible for developing high-quality clinical documents. The role involves planning, writing, and reviewing documents in compliance with regulatory guidelines. The ideal candidate will have a BS degree in a...SeniorRegulatory
$120k - $140k
...to travel as needed. Position Summary Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee the operational aspects... ...includes coverage of 99% of the premium paid for medical, dental and vision plans. Company‑paid life insurance...SeniorRegulatoryWork at officeLocal areaRemote workFlexible hours- ...A leading biopharmaceutical solutions organization is seeking a Principal/Sr Medical Editor to oversee regulatory document editing and quality control. The role requires strong familiarity with FDA and EU guidelines, along with the ability to lead projects and mentor...SeniorRegulatoryRemote workFlexible hours
- ...Principal Medical Writer - PublicationsSyneos Health is a leading fully-integrated life sciences... ..., clinical development plans; IND submissions; integrated summary reports; NDA and... ...scientific meetings.Adheres to established regulatory standards, including, but not limited...RegulatoryContract work
- ...Overview Principal Medical Writer job at ICON Strategic Solutions. Remote. ICON plc is a world... ...the development of high-quality regulatory and clinical documents that effectively... ...be crucial in supporting our clients' submissions to regulatory authorities and ensuring...RegulatoryRemote workFlexible hours
- ...Dart Solutions is seeking a Medical Writer II for a remote role that spans 12 months. The position requires defining and conducting... ...clinical documents while ensuring accuracy and compliance with regulatory submissions. The ideal candidate should possess a Bachelor’s degree...RegulatoryRemote work
$130k - $150k
...A clinical-stage biopharmaceutical firm is seeking a Medical Writer to support clinical development programs. The candidate will be responsible for producing high-quality regulatory documents and collaborating with cross-functional teams to ensure compliance. Requirements...SeniorRegulatoryRemote work- ...Secura Bio is hiring a Director/Senior Director of Global Regulatory Affairs. This strategic leader will develop and implement regulatory strategies... .... Responsibilities include overseeing regulatory submissions and acting as a liaison with regulatory agencies to facilitate...SeniorRegulatory
- ...leading biotechnology company is seeking an Associate Director for Regulatory Affairs, CMC to manage global regulatory strategies for... ...The role involves interfacing with the FDA and producing CMC submissions. Ideal candidates will have 8+ years of experience in CMC regulatory...SeniorRegulatoryRemote work
- ...Bavarian Nordic is seeking a Senior Analyst in Government Pricing to manage complex pricing calculations and support regulatory submissions. This remote position focuses on ensuring compliance with accuracy standards and collaborating across departments. The ideal candidate...SeniorRegulatoryRemote work
- ...company focused on MASH and liver fibrosis is seeking a (Senior) Director, Regulatory Affairs. In this remote role, you will lead U.S. regulatory... ...strategy, particularly for FDA engagement and regulatory submission mechanics. The ideal candidate should have 8+ years of...SeniorRegulatoryRemote work
$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...SeniorRegulatoryRemote work- ...About the job Senior Manager Regulatory Affairs Senior Manager Regulatory Affairs A well-known large consumer products corporation... ...communications Responsible for all US regulatory submissions, supplement notifications, and application of any changes...SeniorRegulatory
$33 - $59 per hour
Medical Technologists- levels I, II and Senior ICON plc is a world-leading healthcare intelligence and clinical... ...for Hematology, Molecular and Immunology. Position Overview: We are seeking... ..., and ensuring compliance with regulatory requirements. Responsibilities:...SeniorRegulatoryWork experience placementFlexible hours$180k - $200k
...Senior Director, Global Head FP&A CellCarta is a leading provider... ...ramps, pricing changes, and regulatory impacts Establish consistent... ...wages ($180,000–$200,000 USD) Medical, dental, and vision benefits... ...integrated analytical platforms in immunology, histopathology, proteomics,...SeniorRegulatoryContract workRemote work- ...Pulse Biosciences is seeking a Medical Writer to develop and edit clinical and regulatory documentation to support medical device development and compliance. Candidates must have a BS in a relevant scientific field and at least 5 years of medical writing experience. Responsibilities...Regulatory
- ...A leading research company is looking for a Sr. VP, Head of Regulatory to lead global regulatory strategies in a remote capacity. The... ...Responsibilities include managing interactions with FDA and EMA, leading submissions, and building a high-performing team. The position offers...SeniorRegulatoryRemote work
- ...Title: Senior/ Principal Statistical Programmer(R) Location: Remote Duration... ...) experience, and exposure to regulatory deliverables (TLFs, ISS/ISE, submissions). Mandatory Skills & Experience:... ...Experience in Oncology, Respiratory, or Immunology, along with RWD/RWE exposure, is...SeniorRegulatoryLong term contractImmediate startRemote work
$144.4k - $189.4k
...BeiGene, Ltd. seeks a Senior Manager, Statistical Programming Project Lead who will be responsible for leading project development... ...collaboration with clinical teams and contributing to regulatory submissions. Salary range for this position is $144,400 to $189,400 annually...SeniorRegulatory- ...Director, Regulatory Affairs – Permanent – Remote Proclinical is seeking a (Senior) Director, Regulatory Affairs for an exciting MASH... ...while overseeing regulatory submission mechanics executed by... ...biopharmaceutical, biotechnology and medical device companies. #J-18808-...SeniorRegulatoryPermanent employmentRemote work
$85k - $110k
...A leading medical communications agency is seeking a Senior Medical Writer who will write accurate and engaging scientific content for healthcare professionals and clients. The ideal candidate will have a PhD or extensive experience, a strong work ethic, and the ability...SeniorRemote work
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