Oncology Regulatory Writing Lead - Senior Principal
Syneos Health Inc
Syneos Health, Inc. is seeking a Sr. Principal Regulatory Medical Writer with oncology experience to develop regulatory submissions. This role involves managing writing projects, collaborating with cross-functional teams, and adhering to global guidelines. The ideal candidate will have extensive experience in regulatory document development and strong organizational skills. Benefits include health insurance, a company car or allowance, and flexible paid time off. #J-18808-Ljbffr
- ...Syneos Health, Inc. is seeking a Sr. Principal Regulatory Medical Writer located in Morrisville, NC. You will develop regulatory submissions, manage writing projects, and collaborate with cross-functional teams to ensure high-quality deliverables. The ideal candidate will...PrincipalSeniorRegulatory
$95k - $210.9k
Sr. Principal Regulatory Medical Writer - Oncology Preferred Updated: Yesterday Location: Morrisville, NC, United States Job ID: 25108891-OTHLOC-1500-2DIL... ...timelines and corporate objectives. Manage medical writing projects, including developing timelines (working with...PrincipalSeniorRegulatoryContract workFlexible hours$80.6k - $145k
...A leading life sciences organization located in Morrisville, NC is seeking an experienced... ...the accurate completion of medical writing deliverables. This role involves managing complex writing projects, adhering to regulatory standards, and mentoring junior writers....SeniorRegulatory- ...Scorpion Therapeutics is seeking a Statistical Programming Lead to oversee statistical programming activities for drug development... ...degree, over 10 years of relevant experience, and knowledge of regulatory submissions. Benefits include comprehensive insurance plans, vacation...PrincipalSeniorRegulatory
- ...experienced Medical Writer to develop and manage high-quality clinical, regulatory, and scientific documents. This role involves close... ...environment. The ideal candidate has demonstrated experience in medical writing and regulatory environments, and is adept at managing...SeniorRegulatoryFull timeContract work
$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... ...and corporate objectives. Manage medical writing projects, including developing timelines (working...PrincipalSeniorRegulatoryContract workFlexible hours- ...Syneos Health, Inc. is seeking a Principal Medical Writer to lead the development and finalization of medical... ...documents for clinical studies and regulatory submissions. The role involves... ...study protocols and reports, managing writing activities, and mentoring junior writers...PrincipalRegulatory
$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... ...regulatory requirements. Writes or provides direction and...PrincipalSeniorRegulatoryContract workFlexible hours- ...LLC is looking for a Medical Writer in North Carolina. This role involves leading medical writing deliverables, managing activities for clinical studies, and ensuring compliance with regulatory standards. The ideal candidate should have 3-5 years of experience in medical...SeniorRegulatory
- ...Parexel is seeking a Senior Clinical Research Associate (SrCRA)... ...experience, particularly in oncology, with strong communication and... ...and emphasizes adherence to regulatory standards, including ICH-GCP.... ...opportunity for personal growth within a leading CRO. #J-18808-Ljbffr...SeniorRegulatoryLocal areaRemote work
- TFS HealthScience is a leading global mid-size Contract Research Organization... .... Join Our Team as a Senior Lead Drug Safety 0.8 FTE... ...safety activities including US regulatory requirements Lead, mentor... ...including Dermatology, Neuroscience, Oncology and Ophthalmology. Our core...SeniorRegulatoryContract workFlexible hours
- ...experienced Medical Writer in Raleigh, NC, to author and manage medical writing deliverables across clinical research phases. The ideal candidate will have at least 5 years of experience in clinical or regulatory writing and a Bachelor's degree in a medical or scientific field...SeniorRegulatoryRemote work
- ...lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality... ...With minimal supervision, authors (writes/edits) high‑quality medical writing deliverables... ...and communicates directly with clients, leads team meetings (e.g., project kickoff,...SeniorRegulatoryContract workWork at officeRemote work
- ...Description: Job Title: Principal Biostatistician Job... ...expected to be a very successful Senior Biostatistician who... ...and oral communications with regulatory agencies. Special expertise... ...communication skills including technical writing of all statistical results....PrincipalRegulatoryRemote work
$70.1k - $145k
...Syneos Health, Inc. is looking for a Medical Writer II to lead the creation and management of critical medical... ...requires 3-5 years of relevant experience in medical writing and a strong understanding of FDA regulatory standards. Responsibilities include collaborating with...SeniorRegulatoryFlexible hours- ...Description Principal Statistical Programmer (US, CAD, UK only) Syneos Health® is a leading fully-integrated life sciences services... ...experience, plus experience writing specifications for ADaM datasets... ...SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains...PrincipalRegulatoryContract work
$80.6k - $145k
...specializing in redaction for clinical trial transparency. Located in Morrisville, NC, the role involves ensuring compliance with regulatory standards and providing quality assurance on various clinical documents. Ideal candidates are detail-oriented, possess strong...SeniorRegulatoryFlexible hours- ...Syneos Health, Inc. is seeking a Senior Medical Writer in Morrisville, NC, to lead and execute comprehensive medical writing deliverables. This role is essential in drug development... ...coordination across departments to meet regulatory standards. The ideal candidate will have...SeniorRegulatory
- ...KBI Biopharma Inc. is looking for a Sr/Principal Computer Systems Validation Specialist in Durham, NC. This individual will oversee enterprise... ...lifecycle deliverables and ensuring compliance with regulatory standards. Candidates need substantial experience in Data Integrity...PrincipalSeniorRegulatoryRemote work
$73.16k - $103.53k
...integrity of controlled substance management within the facility. Candidates should have a Bachelor's degree and relevant experience in regulatory reporting. The position offers a competitive salary range of $73,164-$103,528 along with comprehensive benefits including a 401(k...SeniorRegulatory- Syneos Health, Inc. is looking for a Senior Medical Writer based in Morrisville, NC. This role involves writing, editing, and coordinating clinical and regulatory documents while serving as a... ...this full-time position, you will lead writing deliverables, coordinate activities...SeniorRegulatoryFull timeFlexible hours
- ...Kriya Therapeutics in Morrisville is seeking a Senior Manager, Clinical Data Management to oversee operational data management across... ...clinical programs. This role demands expertise in data quality and regulatory compliance while collaborating with various teams. The ideal...SeniorRegulatoryFlexible hours
- Job Summary Labcorp is seeking a Senior Lead Biostatistician - Oncology Evidence Generation to join our cross‑functional Evidence Generation team, supporting... ...of experience with clinical study documentation and regulatory standards (e.g., protocols, SAPs, GCP principles)....SeniorRegulatoryTemporary workCasual workFlexible hours
$190k - $260k
...Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years of regulatory experience in the bio/pharmaceutical industry and involves overseeing global regulatory strategies for drug development...SeniorRegulatory- ...ECA, headquartered in Raleigh, North Carolina, is seeking a Compliance Manager to oversee regulatory compliance strategies across its affordable housing portfolio. This role involves interpreting Land Use Restriction Agreements (LURAs), tracking compliance timelines,...SeniorRegulatory
- ...Principal Exposure Data Scientist - Chemical Insights Research Institute... ...assessment, risk assessment, regulatory decisions, and public health... ...diverse audiences, including senior management, amplification... ...technical reports.* Assist in writing research proposals and securing...PrincipalRegulatoryWork at officeFlexible hours
- ...Parexel is seeking a Senior Regulatory Consultant – Advertising & Promotion to provide strategic regulatory guidance across cross‑functional teams. This position requires extensive experience in FDA regulations and the ability to advise senior stakeholders on compliant...SeniorRegulatory
- ...additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required... ...key holder work experience. Must be fluent in reading, writing, and speaking English. (Except in Puerto Rico) Preferred...RegulatoryWork experience placementSeasonal workLocal areaShift work
- Green Alpha Property Management in Raleigh, North Carolina is seeking a Compliance Manager to oversee regulatory compliance strategies across their affordable housing portfolio. The role focuses on interpreting Land Use Restriction Agreements (LURAs), tracking affordability...SeniorRegulatory
$119.26k - $163.98k
## Lead Risk Assessment Research ScientistApplylocations: Morrisville, NCtime type: Full... ...endpoints to inform chemical safety, regulatory policy, and public awareness. **UL Research... ...and its utility, responding verbally or in writing to questions from peer-reviewers, and...RegulatoryWork experience placementWork at officeWorldwideFlexible hours
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