Senior Medical Writer: Regulatory & Clinical Docs Lead
$70.1k - $145kSyneos Health Inc
Syneos Health, Inc. in Morrisville, NC, is seeking a Senior Medical Writer to lead the writing of clinical and regulatory documents. This role requires expertise in FDA and ICH regulations and prior experience in the biopharmaceutical sector. Responsibilities include managing medical writing activities, ensuring deliverables are completed on time, and mentoring less experienced writers. The position offers a competitive salary range of $70,100 to $145,000 based on qualifications. #J-18808-Ljbffr
$95k - $210.9k
Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have) - Oncology Preferred Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every...SeniorRegulatoryContract workFlexible hours$80.6k - $145k
...Sr Medical Writer, Redaction (Clinical Trial Transparency) Updated: April 29, 2026 Location: Morrisville, NC, United States Job ID: 25105719-OTHLOC... ...trial transparency documents, ensuring compliance with regulatory submission standards and company processes. The role...SeniorRegulatoryFlexible hours- ...pharmaceutical, biotech, and medical device industries with... ...complex trial data and regulatory submission challenges.... ..., the Medical Writer will critically evaluate... ...bias Write and edit clinical development documents,... ...protocol experience, as lead author, required Experience...SeniorRegulatoryRemote workWorldwide
$70.1k - $145k
...Description Medical Writer II/ Sr Medical Writer Syneos Health® is a leading fully-integrated life sciences... ...progress. Our Clinical Solutions team members... ...Job Summary Senior medical writer on clinical study or regulatory project teams. Writes,...SeniorRegulatoryContract workFlexible hours$70.1k - $145k
...ID: 25109024-OTHLOC-1500-2DMO-2DR Syneos Health is a leading fully-integrated life sciences services organization... ...progress. Job Responsibilities Job Summary Senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content...SeniorRegulatoryContract workFlexible hours- ...expertise that empowers biotech, medical device, and pharmaceutical... ...deep domain expertise in regulatory sciences, clinical research solutions, quality... ...less experienced medical writers, as necessary. Adhere to... ...interact directly with clients; lead team meetings (e.g.,...SeniorRegulatoryContract work
$84.4k - $211.1k
...Job Overview: Acts as Lead Medical Writer on most types of writing projects. Prepares... ...the agreed timelines. Performs Senior Review of straightforward... ...medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments...SeniorRegulatoryFull timePart timeLocal areaImmediate startWorldwide- 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
- ...inVentiv Health Commercial LLC is seeking a Sr. Principal Medical Writer to develop clinical documents for global submissions. Ideal candidates... ...extensive medical writing experience and a strong knowledge of regulatory standards, particularly in oncology. This role requires...SeniorRegulatory
- ProPharma is looking for an experienced medical writer in Raleigh, North Carolina. The ideal candidate will have a minimum of 7 years of experience in writing clinical and regulatory documents, with the ability to lead and manage various medical writing deliverables. You...SeniorRegulatory
$70.1k - $145k
Syneos Health/inVentiv Health Commercial LLC is seeking a Senior Medical Writer based in North Carolina. The role involves leading the preparation of clinical and regulatory documents while ensuring compliance with regulatory standards. Ideal candidates will have a Bachelor...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... ...completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects...SeniorRegulatoryContract workWork from home
$120k - $159k
Overview Join to apply for the Senior/Principal Medical Writer - USA role at Trilogy... ...growing company in producing regulatory documentation for the... ...writers are integral members of clinical development teams... ...scientific publications) as the lead writer in collaboration...SeniorRegulatoryLive inWork at officeRemote workWork visa- GSK is hiring a Principal Medical Writer in Durham, North Carolina, responsible for leading the authoring of clinical and regulatory documents. The ideal candidate has over 5 years of experience in medical writing and a Bachelor’s degree in life sciences or a related field...SeniorRegulatory
- 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 candidate will mentor junior writers while managing complex medical writing tasks across various therapeutic...SeniorRegulatoryRemote jobWork from home
- Duke Cancer Institute in Durham, NC seeks a Senior Clinical Research Coordinator to lead a team conducting complex oncology trials, including IP studies... ...and multidisciplinary teams, overseeing regulatory documents, budgets, and data integrity, while contributing...SeniorRegulatory
- Velocity Clinical Research, Inc. is seeking a Subject Matter Expert and leader to manage... ...protocol, GCP, and Velocity SOPs. You will lead study teams, mentor staff, develop... ...startup, recruitment, data management, and regulatory documentation while upholding patient safety...SeniorRegulatory
- ...professionals for Project Leader and Senior Project Leader roles within its Global... ...Project Leadership organization. You will lead global clinical studies across various therapeutic... ...experience in scheduling, resources, and regulatory submissions. #J-18808-Ljbffr ParexelSeniorRegulatory
$70.1k - $145k
...Job Responsibilities Senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents... ...internal team and the client. Core Responsibilities Lead the clear and accurate completion of medical writing...SeniorRegulatoryFlexible hours- Ll Oefentherapie is seeking a Senior Product Manager to oversee product management, regulatory documentation, and software development across medication processes. The candidate will leverage... ...including engineering, regulatory, and clinical stakeholders. Ideal candidates...SeniorRegulatory
$95k - $210.9k
Sr. Principal Regulatory Medical Writer - Oncology Preferred Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer... ...change and accelerate progress. Our Clinical Solutions team members act with a drug development...SeniorRegulatoryContract workFlexible hours- ...Principal Medical Writer ViiV Healthcare, a global specialty HIV company, is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical...RegulatoryLocal areaRemote work
$84.4k - $211.1k
...Job Overview Acts as Lead Medical Writer on any type of writing project, including... ...the agreed timelines. Performs senior review of all types of medical writing... ...and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments...RegulatoryFull timePart time- ...impact of HIV on individuals and communities.ViiV Healthcare is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects. You will work closely with clinical, regulatory, statistical, and cross-...RegulatoryLocal areaRemote work
- WCG is seeking a Senior Principal Statistical Programmer in Cary/Remote USA to lead complex programming efforts for clinical trials. You will design, validate, and standardize outputs... ...cross-functional teams and ensuring regulatory compliance. You will mentor staff, champion...SeniorRegulatoryRemote job
- ...seeking a CRC II to be onsite in Marietta, GA for coordination of clinical trial activities. The role involves protocol review, TMF... ...excellent communication are required. Responsibilities include regulatory documentation, data entry, and collaboration with study teams...Regulatory
- A leading game development company is seeking an experienced attorney to join their regulatory compliance team. This role involves advising senior management on global laws and regulations, leading compliance strategies, and responding to regulatory inquiries. The ideal...SeniorRegulatory
- ...Carolina, is looking for a qualified attorney with at least 8 years of experience in regulatory compliance. The role involves advising senior management on global laws and regulations, leading compliance strategies, and supporting advocacy efforts with regulatory bodies....SeniorRegulatory
- Relias, headquartered near Morrisville, NC, seeks a Senior Product Manager to lead cross‑functional teams including Product, UX and Engineering.... ...development of new healthcare product offerings, translate regulatory requirements, and drive market-ready solutions in a fast-...SeniorRegulatory
- Syneos Health, Inc. in Morrisville, NC is seeking a Senior Site Contracts Specialist to manage site contract and budget negotiations for clinical trials. This role offers an opportunity to work independently with cross-functional teams to streamline the process of bringing...SeniorRemote jobContract workFlexible hours
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