Senior Medical Writer - Clinical & Regulatory Leadership
GSK LLP
GSK is seeking a Principal Medical Writer in Durham. This role focuses on leading high-quality medical writing for complex clinical and regulatory projects. Candidates must have a bachelor's degree in life sciences and 5+ years of experience in the pharmaceutical industry. The position involves managing writing projects, coordinating various contributors, and ensuring documents meet regulatory standards. Preferred qualifications include advanced degrees and experience with regulatory submissions. Join a diverse team at GSK and make an impactful contribution. #J-18808-Ljbffr GSK LLP
$120k - $159k
...Consulting, a Indegene Company, is hiring Senior/Principal Medical Writers (USA) to support our growing company in producing regulatory documentation for the international... ...writing. Our writers are integral members of clinical development teams supporting the writing...SeniorRegulatoryLive inWork at officeRemote workWork visa- VOANS is seeking a Medical Director in Durham, NC to oversee clinical care for Senior CommUnity Care. You will guide providers, develop... ...and a benefits package. Strong leadership, collaboration across disciplines, and compliance with regulatory standards are essential. #J-18...SeniorRegulatory
$173.2k - $216.5k
...the forefront. We hold a leadership position in Duchenne muscular... ...of the Role The Senior Neuromuscular Clinical Sales Specialist (NCSS) is... ...use of Sarepta Therapies to medical providers across their assigned... ...judgment and adheres to relevant regulatory and compliance guidelines...SeniorRegulatoryFull timeLocal area$93.1k - $232.8k
...are seeking a US-based Senior Project Manager with proven... ...the delivery of clinical trials and improving patient... ..., SOPs, and regulatory standards. This role combines strategic leadership, operational excellence... ...commercialization of innovative medical treatments to help improve...SeniorRegulatoryFull timePart timeLocal areaImmediate startWorldwide$125.3k - $349k
...is located.About IQVIA Clinical & Patient... ...insight.Role OverviewThe Senior Director, Sales - Large... ...account development, and leadership of a team of Account Executives... ...challenges, evolving regulatory complexity, and the... ...commercialization of innovative medical treatments to help...SeniorRegulatoryFull timePart timeImmediate startWorldwide$93.1k - $232.8k
Senior Clinical Project Manager - Global Study LeadershipAt IQVIA, our Senior... .... You'll provide strategic leadership for complex global clinical... ...quality, timeline, budget, regulatory and customer objectives are... ...of innovative medical treatments to help improve patient...SeniorRegulatoryFull timePart timeImmediate startWorldwideFlexible hours$93.1k - $232.8k
...patients faster.Drive global clinical trials from first site... ...ensure compliance with ICH-GCP, regulatory requirements, and study protocols... ...that combines strategic leadership, operational execution, and... ...commercialization of innovative medical treatments to help improve...SeniorRegulatoryFull timeContract workPart timeWork at officeImmediate startWorldwide- ...quality and excellence. We are Worldwide Clinical Trials, a global team of over 3,500... ..., which are crucial for groundbreaking regulatory submissions. The team includes data support... ...to which you are assigned; provide leadership to the corresponding data management teams...SeniorRegulatoryWorldwide
$93.1k - $232.8k
...are an integral part of clinical trial delivery,... ...the market faster. The Senior Project Lead is an essential... ...and strategic leadership with our customers.Essential... ...applicable clinical research regulatory requirements i.e. ICH... ...of innovative medical treatments to help improve...SeniorRegulatoryFull timeContract workPart timeLocal areaImmediate startWorldwide- GRAIL is seeking a Clinical Laboratory Specialist V to perform advanced post-analytical review of high-throughput clinical genomics data... ..., with emphasis on sequencing metrics, assay performance, and regulatory compliance. You will work on-site full-time in Durham, NC,...SeniorRegulatoryFull time
- IQVIA is seeking a seasoned QA leader to provide strategic oversight across GxP-regulated programs, with emphasis on clinical research, regulatory adherence, and patient safety. You will drive risk-based decision making, CAPA effectiveness, and continuous improvement across...SeniorRegulatory
$85k - $120k
...Senior Clinical Data ManagerData Management leadership on studies and take responsibility for the development of the project... ...of the relationship and regulatory obligation of the CRO industry with... ...comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD,...SeniorRegulatoryFull timePart timeWork experience placementWork at officeLocal areaRemote workFlexible hoursNight shift- An established industry player is seeking a seasoned Business Analyst with a strong clinical regulatory background. With over 10 years of experience in the Pharmaceutical and Biotech sectors, you will play a crucial role in enhancing clinical development processes and managing...SeniorRegulatory
$59.83k - $99.96k
Clinical Research Coordinator (Spanish Bilingual) - School of Nursing... ...screening of electronic medical records, enrolling English‑... ...Manage study operations and regulatory compliance: maintain documentation... ...as co‑author. Demonstrate leadership and professional development...SeniorRegulatoryFull timeTemporary workWork at officeWeekend workAfternoon shift- Fortrea’s Phase I team seeks a Sr. Clinical Project Manager to join our growing operations. This role requires 4-5+ years of global project... ...global projects, drive risk and scope, coordinate cross-functional teams, and ensure regulatory data quality. #J-18808-Ljbffr FortreaSeniorRegulatoryRemote job
- .../Must Have: 1+ years of relevant work experience in a clinical environment or medical setting. High school diploma (A BS would be a plus) or... ...required by the company, country, state, and/or other regulatory bodies. Responsibilities: Provide clinical research...SeniorRegulatoryWork experience placement
$87.2k - $169.3k
IQVIA Early Clinical Development is hiring for a Senior CRA 1. Ideal candidates will have Phase 1 experience across... ...compliance with study protocols, regulatory requirements, and sponsor... ...and commercialization of innovative medical treatments to help improve patient...SeniorRegulatoryFull timePart timeImmediate startWorldwide$118.69k - $189.91k
...DescriptionWe are hiring for a Senior Clinical Pharmacist! This individual... ...stakeholders, providing leadership across formulary management,... ...closely with internal pharmacy, medical, finance, analytics,... ...compliance with applicable regulatory, accreditation, and quality...SeniorRegulatoryFull timeLocal areaRelocationFlexible hours$125.9k - $350.9k
...seeking an accomplished Clinical Project Management... ...programs and partnering with senior sponsor stakeholders... ...is a highly strategic leadership role offering the... ...data management, safety, regulatory, and other functional... ...commercialization of innovative medical treatments to help...RegulatoryFull timePart timeImmediate startWorldwide$87.2k - $169.3k
...Full time R1540075 IQVIA Early Clinical Development is hiring for a Senior CRA 1. Ideal candidates will have... ...compliance with study protocols, regulatory requirements, and sponsor expectations... ...commercialization of innovative medical treatments to help improve patient...SeniorRegulatoryFull timePart timeImmediate startWorldwide- ...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
$84.4k - $211.1k
...of America Full time R1548854 Overview We are seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring...RegulatoryFull timePart timeImmediate startWorldwide$66.5k - $131.5k
...Medical Writer IIThe Late Phase Medical Writer II is responsible for carrying out medical writing... ...ethical standards in accordance with regulatory requirements and Worldwide quality... ...informed consent documents and assents, clinical trial reports (CTRs) including efficacy...RegulatoryWork at officeWorldwideNight shift- Duke Health is seeking a Clinical Nurse IV Leader in Cardiology at Duke Cardiology Arringdon, Morrisville, NC.... ...years of nursing experience. This position emphasizes leadership, collaboration, and adherence to regulatory standards within Duke #J-18808-Ljbffr Duke...Regulatory
- 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
- A senior living community in Durham, NC, is seeking a Resident Care Director (RN) to oversee clinical operations within Assisted Living and Memory Care. This leadership role ensures high-quality, person-centered care... ...and compliance with regulatory standards. The position...SeniorRegulatory
- Trilogy Writing & Consulting is seeking Senior/Principal Medical Writers to support growth and deliver regulatory documents for the pharmaceutical industry. Key responsibilities include leading the writing of clinical regulatory documents and managing multiple projects...RegulatoryRemote jobWork at office
$87.5k - $173.5k
...Senior StatisticianIndependently manages statistical project support... ...sponsors in the design of clinical trials, including statistical... ...(e.g., SAS and nQuery), and regulatory guidance documents, e.g. International... ...in providing statistical leadership to projectsDesign and...SeniorRegulatoryWorldwide- Brighton Health Plan Solutions is seeking a Senior Manager of Medical and Clinical Claim Policy and Configuration to oversee policy content and system... ..., CODING rules, and policy publication while ensuring regulatory alignment and operational #J-18808-Ljbffr Brighton Health...SeniorRegulatoryRemote job
$186.3k
Job Posting Title- Senior Medical Director, Hematology/OncologyLocation... ...leader who provides scientific, clinical, and operational oversight... ..., clinical study reports, regulatory approval submissions, serious... ...consultants, etc.Clinical Leadership & Study ExecutionSupport site...SeniorRegulatoryFull timePart timeImmediate startRemote workWork from homeWorldwideShift work
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