Senior Medical Writer: Regulatory & Clinical Docs Lead
Oxford Global Resources
Oxford Global Resources is seeking an experienced Medical Writer to author, coordinate, and quality‑check clinical, regulatory, and scientific documents supporting drug development. The role involves managing external medical writing resources and ensuring timely delivery across NDA, IND, and CTD workflows. You will collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and Project Management to align scope and insights, while maintaining high standards of English #J-18808-Ljbffr Oxford Global Resources
$109k
A leading global healthcare company is looking for a Medical Writer III in Raritan, NJ. This role involves writing and coordinating essential clinical and regulatory documents. Candidates should have at least 6 years of relevant experience and strong communication skills...SeniorRegulatory$232k - $401.35k
...Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...(J&J) is seeking a Senior Director, Clinical Lead - Neuropsychiatry to be located... ...development and execution of medical and scientific strategies... ...documents for global regulatory filings. The CL will manage...SeniorRegulatoryFull timeLocal areaImmediate start- ...Sr. Medical Writer job at Terumo Medical Corporation. Somerset, NJ. Combining knowledge of science... ...the development and creation of clinical and scientific documents to present information... ...procedure Medical, Writer, Clinical, Regulatory Affairs, Evaluation, Literature,...SeniorRegulatory
- ...An established industry player is seeking a Nonclinical Regulatory Document and Scientific Writer to join their dynamic team. This role requires a strong background in DMPK and regulatory drug development, with responsibilities including authoring and reviewing critical...SeniorRegulatory
- Precision Medicine Group is seeking a clinical trial lead to oversee the operational aspects of clinical studies, ensuring adherence to protocol, SOPs, ICH-GCP, and regulatory requirements. You will manage feasibility, site start-up, enrollment, and quality deliverables...SeniorRegulatory
- ...this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and... ...assurance check of documents, and management of external medical writers. Project Details: Author or coordinate the authoring of...RegulatoryHourly pay
- ...combination products and/or medical devices. The applicant should... ...design controls, and be able to lead and conduct FMEAs. Specific... ...development processes, cGMPs and regulatory requirements are required.... ...material prepared by other writers or establishment personnel 2...Regulatory
$102k - $175.95k
...the best talent for a Senior ServiceNow Architect to... ...architecture diagrams, design docs, and implementation... ...ensure solutions meet regulatory and internal... ...Collaborate closely with domain leads and cross-functional stakeholders... ...benefit programs: medical, dental, vision, life...SeniorRegulatoryFull timeTemporary workLocal areaImmediate start- ...Summary: We are seeking a Senior Business Analyst - Veeva Vault... ...Integration for Veeva Quality Docs/QMS implementation within the... ...specifications. Plan and lead workshops and interviews with... ...stakeholders across Quality Assurance, Regulatory Affairs, and Compliance....SeniorRegulatory
- Johnson & Johnson Innovative Medicine seeks a Sr. Regulatory Affairs Professional, Global TA, to support drug development programs and lifecycle management across multiple therapeutic areas. The role offers a rotational model addressing business needs and career development...SeniorRegulatory
$137k - $235.75k
...hands-on scientific and technical leader, leading a portfolio of RWE projects, developing... ..., and literature reviews to support regulatory agency interactions.Independently create... ...claims, registry data). Familiarity with clinical trial data structureExcellent interpersonal...SeniorRegulatoryFull timeLocal areaImmediate start- Johnson & Johnson Innovative Medicine is seeking a Senior Manager, Regulatory Affairs Labeling Product Leader for a hybrid role based in New Jersey... ...or Pennsylvania. You will drive global labeling strategy, lead target labeling development, and collaborate with cross-...SeniorRegulatory
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Specialist to support the Instrumentation & Accessories... ..., collaborating closely with engineering and clinical teams. Applicants should have 4+ years in medical device regulatory affairs, strong submission...SeniorRegulatoryRemote job
- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Program Lead to drive regulatory strategy for OTTAVA robotic instruments and accessories. You will partner with engineering and clinical teams, develop submission-ready documentation, and guide global regulatory...SeniorRegulatoryRemote job
- ...Americas seeks a Principal Project Manager to lead multi-disciplinary teams in delivering capital... ...definition, risk management, vendor relations, and regulatory compliance across large industrial gas facilities. This senior role requires extensive experience in project...SeniorRegulatory
- ...collective progress and impact.The Senior Director of Advertising & Promotion- Regulatory Affairs drug and device products... ...and Canadian action letters and leads the company in discussions with the... ...with Legal, Compliance and Medical Affairs regularly. Also works with...SeniorRegulatoryTemporary workWork at officeFlexible hours
- Legend Biotech seeks a Senior Manager, MSAT - Viral Vector Lead to provide technical leadership for viral vector... ...in vivo programs across clinical and commercial lifecycles. This role... ...Development, Manufacturing, Quality, Regulatory, and Supply Chain to enable reliable...SeniorRegulatory
- ...Safety (EHS) Sr. Specialist for the third shift at our New Jersey GMP cell therapy facility. You will drive EHS culture, ensure regulatory compliance, and support site programs across Environmental, Health, and Safety functions; collaborate with operations, engineering...SeniorRegulatoryShift work
- Legend Biotech is seeking an EHS Senior Specialist for the 3rd shift at our Raritan, NJ facility. The role focuses on supporting EHS... ...therapy manufacturing environment, driving strong EHS culture and regulatory compliance. The ideal candidate has 5-7 years of relevant EHS...SeniorRegulatoryNight shift
$136.89k - $209.2k
...Senior Counsel Position Summary: Full time salaried position... ...research and development, clinical supply manufacturing, and commercial... ...relations, contract matters, regulatory issues Assist in merger... ...~ Generous 401K match ~ Medical, dental and vision benefits effective...SeniorRegulatoryFull timeContract workWork at officeLocal area- Everest Clinical Research invites applications for a Senior Clinical Data Manager role based in Bridgewater, New Jersey, with on-site duties and work-from-home... ...the USA under our policy. The position emphasizes leading data management activities, CRF design, timelines,...SeniorRemote jobWork from home
- A software development company seeks a Clinical Research Associate in Raritan, NJ. The ideal candidate will have at least 5 years of... ...necessary. The role involves managing clinical trial sites, ensuring regulatory compliance, and working with cross-functional teams. This...SeniorRegulatory
- ...Packaging Designer-CPGWe are seeking an experienced Freelance Lead Graphic Designer with a strong background in consumer packaged... ...ensure print accuracy.Collaborate with Brand Marketing, Packaging, Regulatory, and Production teams.Maintain brand consistency across...SeniorRegulatoryFreelance
$62.5k - $93.75k
Position Summary The Medical Writer is responsible for developing and writing content for their assigned account(s) and works in conjunction... ...pharmaceutical clients, as necessary Attend medical, legal, regulatory review meetings, as necessary Participate in all internal...Regulatory- ...their merit.Job Function: Regulatory Affairs GroupJob Sub... ...the best talent for a Senior Regulatory Affairs Specialist... ...engineering and clinical teams, as well as supporting... ...experience within Medical Device is required (3+... ...skills with the ability to lead multiple projects/tasks...SeniorRegulatoryFull timeLocal areaImmediate startRemote work
$90k - $105k
...Senior Payroll AnalystAmneal Pharmaceuticals LLC is seeking a Senior Payroll Analyst to lead and manage daily payroll operations, ensuring accuracy, compliance, and timely processing... ...Support workers' compensation and other regulatory reporting. Prepare payroll reports and...SeniorRegulatoryFull timeTemporary workFlexible hours$150k - $170k
Description:The Senior Alliance Accounting Manager is responsible for leading the finance operations, reporting, billing support, contract compliance monitoring... ...functionally with business development, FP&A, legal, R&D, regulatory affairs, commercial, tax, treasury, technical...SeniorRegulatoryContract workTemporary workFlexible hours$137k - $235.75k
...their merit.Job Function: Regulatory Affairs GroupJob Sub... ...R&D is recruiting for a Senior Manager, Regulatory Affairs... ...partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the...SeniorRegulatoryFull timeWork experience placementLocal areaImmediate startWorldwide$178k - $307.05k
...cybersecurity, data, AI, and technology risk.As the Senior Legal Director, Cyber & Data Risk, you... ...decisions, emerging risks, and evolving regulatory requirements affecting the organization's... ..., technology transactions, and data.Lead and develop a team of cybersecurity legal...SeniorRegulatoryFull timeLocal areaImmediate start- ...seeks an experienced in-house counsel to serve as a hands-on legal architect across commercial agreements, government contracts, regulatory matters, corporate governance, and employment. You will build guardrails to let the business move fast with confidence, advise the...SeniorRegulatory
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