Senior Medical Writer — Regulatory Submissions Expert
MMS
MMS is a data-focused CRO seeking an experienced Medical Writer to analyze medical literature, develop regulatory documents, and ensure scientific rigor in study materials. You will draft protocols, study reports, and safety summaries, coordinating with clients and project teams on timelines. The role requires leadership in writing projects, experience with regulatory submissions, and strong MS Office skills, with collaboration across cross-functional teams to deliver compliant documents. #J-18808-Ljbffr MMS
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Senior Medical Writer — Regulatory Submissions Expert in Raleigh, NC vacancy
- Syneos Health in Remote/NC seeks a Senior Medical Writer with proven clinical document writing experience. You will... ...with data management, biostatistics, regulatory and medical affairs to produce high-quality submissions. Minimal travel may be required. #J-18808-Ljbffr...SeniorRegulatoryRemote job
- Syneos Health is seeking a senior medical writer with proven clinical document writing experience... ...of clinical study documents and submissions. This role coordinates writing activities... ...mentors junior writers, and ensures regulatory alignment across multiple stakeholders...SeniorRegulatory
- ...be based anywhere in the US. Summary: Serves as a senior medical writer on clinical study or regulatory project teams. Plans and coordinates report-writing... ...protocol amendments clinical study reports IND submissions and annual reports Integrated summary reports NDA...SeniorRegulatoryContract workWork from home
- ...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
- ...that empowers biotech, medical device, and... ...deep domain expertise in regulatory sciences, clinical research... ..., NDA, BLA, MAA, eCTD submission‑level documents). Supervise... ...experienced medical writers, as necessary. Adhere... ...with subject matter experts in clinical operations...SeniorRegulatoryContract work
- INC Research is seeking a Senior Medical Writer to support clinical study and regulatory project teams. This position is home based anywhere in the US. The ideal... ...deliverables like clinical protocols, IND submissions, and more, adhering to regulatory standards. Applicants...SeniorRegulatoryRemote jobWork from home
- ...Associate Director/Director/Sr. Director, Regulatory CMC to lead global CMC regulatory... ...commercialization of biologics. You will guide submissions, risk mitigation, and cross-functional... ..., partnering with CMOs and external experts to support product lifecycle management...SeniorRegulatory
- ProPharma in Raleigh, North Carolina, seeks a skilled medical writer with at least 5 years of experience. The role involves authoring a variety of clinical and regulatory documents while ensuring adherence to regulatory standards. The ideal candidate will demonstrate strong...SeniorRegulatory
- ProPharma is looking for an experienced medical writer in Raleigh, North Carolina. The ideal... ...of experience in writing clinical and regulatory documents, with the ability to lead and... ...You will collaborate with subject matter experts and ensure timely completion of projects...SeniorRegulatory
- Syneos Health seeks a Senior Medical Writer/PMW with proven strong clinical document writing experience to join our Clinical Solutions team. You will lead the clear and accurate completion of regulatory documents across studies, coordinating activities with minimal supervision...SeniorRegulatory
- Syneos Health is seeking a senior Medical Writer to lead the production of high-quality medical writing deliverables across multiple study documents... ..., coordinating with data management, biostatistics, regulatory affairs, and medical affairs. You will ensure regulatory...SeniorRegulatory
- Syneos Health is seeking a principal medical writer to lead the development and review of complex regulatory and scientific documents, ensuring accuracy and alignment with client goals and regulatory guidelines. The role includes mentoring junior writers, coordinating cross...SeniorRegulatoryRemote job
$92.97k - $129.23k
Expert Product Advisor - Payer Encounters Submission Partners closely with highly complex and strategic payer/health plan customers to serve as a strategic... ...workflows, claims integration, risk adjustment, and CMS regulatory requirements into actionable product insights,...Regulatory$70k - $98k
...societal value of creative medical treatments to payers,... ...you an experienced Senior Medical Editor in the... ...and works with clinical writers, account teams,... ...with each client’s MLR submission process and support the... ...with the medical/legal/regulatory submission preparation...SeniorRegulatoryWork at officeFlexible hours$75k - $122.5k
...standard CST business hours. As a Senior Scientific Associate, you will write medical content for our clients while... ...necessary. Attending medical, legal, regulatory review meetings. Participating... .... Mentoring junior level writers. Qualifications Doctorate level...SeniorRegulatory- JPMorgan Chase & Co. is looking for a Senior Home Lending Advisor in Raleigh, NC. This role involves serving as the primary point of contact for customers while ensuring compliance with regulatory requirements. Responsibilities include mentoring team members, developing...SeniorRegulatory
- ...takes curious minds, problem-solversand experts who care about getting it right. It also... ...Supporting the client in all aspects of safety submission Supports the Submission Manager in... ...knowledge and understanding of global regulatory reporting requirements to ensure compliance...SeniorRegulatoryWork experience placement
- SCN BestCo is seeking a Senior Maintenance Planning Supervisor to lead a world-class maintenance team and optimize planning, scheduling... ...PMs with OEM guidance and RCA findings, and ensuring regulatory and safety compliance across the site. #J-18808-Ljbffr NCBiotechSeniorRegulatory
- ...ProPharma is seeking an experienced Senior Medical Writer to support medical writing deliverables across clinical research and regulatory domains. In this hybrid role, you will author... ...reports, CSRs, IBs, and regulatory submissions, coordinating with cross-functional teams...Regulatory
$145k
Premier Research is looking for a Senior Regulatory Submissions Lead to join our Regulatory Submissions... ...of our team, you help us deliver the medical innovation that patients are desperate... ...support by serving as a subject matter expert in specialized areas and complex...SeniorRegulatoryTemporary work- ...Commission. Position: The Medical Writing function plays... ...-quality clinical, regulatory, and scientific... ...clear, accurate, and submission-ready documentation aligned... ...expectations. The Medical Writer collaborates closely... ...documents and, at the senior level, lead complex...RegulatoryContract work
- Syneos Health in the United States is seeking a Sr Medical Writer for Late Phase inflammation programs. You will lead the creation... ...and medical affairs to deliver high-quality manuscripts and regulatory submissions. The role requires mentorship of junior writers, strict...RegulatoryRemote job
- TG Therapeutics, Inc. is seeking an experienced Medical Writer II or III to author and lead clinical, regulatory, and scientific documents across programs. You will... ...Affairs, Biostatistics, and Safety to ensure submission-ready deliverables and alignment with regulatory...Regulatory
- ...Overview:This position will serve as a Nationally Recognized Senior Subject Matter Expert (SME) to provide Senior Technical Advisory services to... ...briefings to agency leadership and public boards, regulatory bodies, and community stakeholders with absolute clarity...SeniorRegulatoryHourly payPart timeLocal areaRemote workFlexible hours
- ...leading biopharmaceutical company in North Carolina seeks an experienced Senior Director, Head of Regulatory Affairs. This role involves defining global regulatory strategy and overseeing submissions, with a focus on biologic products. Candidates should have over 15...SeniorRegulatory
- Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to serve as... ...cross‑functional teams in North America. You will author HA submissions for US and Canada, guide strategy, and ensure compliance with...SeniorRegulatory
- RTI International is seeking a Senior Nonclinical Regulatory Affairs Scientist to lead nonclinical regulatory strategy and drive regulatory submissions across a diverse portfolio of products. You will work with clients, sponsors, CROs, and RTI’s multidisciplinary teams...SeniorRegulatory
- Grifols seeks a Regulatory Affairs professional in Clayton, NC to implement global registration strategies, ensuring compliance with... ...collaborating with various departments to manage regulatory submissions effectively. Qualified candidates should have a Bachelor’s degree...SeniorRegulatory
$172.5k - $222.5k
...What you’ll be responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global... ...remediation of any identified findings.Supporting submission of regulatory reports, validating data accuracy, and ensuring...SeniorRegulatoryFlexible hours- ...projects by analyzing trial data, validating outputs, and ensuring regulatory compliance. You will work with SAS and R to produce high-... ...Responsibilities include reviewing SAPs, CSRs, and regulatory submission data, collaborating with cross-functional teams, and maintaining...RegulatoryRemote jobFor contractors
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Medical Writer — Regulatory Submissions Expert. Be the first to apply!
Related searches
- medical writer Raleigh, NC
- senior medical writer Raleigh, NC
- medical editor Raleigh, NC
- fulfillment expert Raleigh, NC
- guest service support expert Raleigh, NC
- technology expert Raleigh, NC
- srs distribution Raleigh, NC
- senior associate architect Raleigh, NC
- senior dynamics crm developer Raleigh, NC
- senior application security Raleigh, NC

