Lead Medical Writer - Clinical & Regulatory Strategy
GlaxoSmithKline
GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences. This role requires strong collaboration and communication skills to work with cross-functional teams. Benefits include a comprehensive program for US employees, along with opportunities for professional growth. #J-18808-Ljbffr GlaxoSmithKline
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Lead Medical Writer - Clinical & Regulatory Strategy in Durham, NC vacancy
- 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...Regulatory
- 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
- ...9Reference26-00208 Responsibilities: Lead and manage clinical data management activities for oncology... ...alignment with study protocols and regulatory requirements. Oversee the design, build... ...ensure alignment of data management strategies with overall clinical development...RegulatoryWork at office
- ...therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team... ..., and deliver practical regulatory solutions. This role... ...with oncology clinical data and endpoints. Prior... ...strategy with commercial and medical affairs objectives. Track...RegulatoryLocal area2 days per week3 days per week
- ...seeking a senior leader to oversee the clinical data technology ecosystem, including... .... This role informs systems strategy, governs configurations, and leads a dedicated platforms team to ensure data integrity and regulatory readiness. You will partner with cross...Regulatory
- IQVIA's Senior Clinical Project Manager - Global Study Leadership leads strategic delivery of large-scale, multi-regional... ...will drive risk management, ensure regulatory compliance and foster... ...collaboration across regions, shaping study strategy and delivering impactful...RegulatoryWorldwide
- Pedestal Health is seeking a Study Start-Up and Regulatory Manager to lead regulatory and start-up activities for multiple clinical research projects. You will act as the SME for IRB/IEC submissions, essential documents, and TMF maintenance, ensuring activation and audit...Regulatory
- ...Agent to develop and execute the company's intellectual property strategy, reporting to the Associate General Counsel, Commercial Legal and Compliance. You will interact with inventors, R&D and regulatory teams to secure IP protection for biopharmaceutical programs in the...Regulatory
- UnitedHealth Group, a global leader in health care, seeks a Clinical Specialty Program Pharmacist to lead specialty execution across clinical strategies and patient care support. This role involves KPI reviews, forecasting, and driving initiatives with client teams across...Remote job
- ...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
GSK LLP
Durham, NC4 days ago $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 startWorldwideIQVIA
Durham, NC3 days ago- Foundation Medicine, Inc. is seeking a Sr Regulatory Affairs Specialist to support regulatory submissions and health authority interactions... ...diagnostic products in the US. This role develops regulatory strategy and prepares submission packages for FDA approvals,...Regulatory
$66.5k - $131.5k
...Medical Writer IIThe Late Phase Medical Writer II is responsible for carrying... ...in accordance with regulatory requirements and Worldwide quality... ...What you will doPrepare and lead the medical writing team on... ...documents and assents, clinical trial reports (CTRs) including...RegulatoryWork at officeWorldwideNight shiftWorldwide Clinical Trials
Durham, NC1 day ago$120k - $159k
..., is hiring Senior/Principal Medical Writers (USA) to support our growing company in producing regulatory documentation for the international... ...are integral members of clinical development teams supporting... ...scientific publications) as the lead writer in collaboration with...RegulatoryLive inWork at officeRemote workWork visaTrilogy Enterprises
Durham, NC3 days ago- 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...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
- ...Wealth Strategist in Chapel Hill, NC to lead advanced wealth planning for ultra‑high‑... ...external professionals to deliver integrated strategies across estate, tax, investment,... ...planning capabilities while maintaining regulatory compliance and firm standards. #J-18808...Regulatory
- ...seeking an Associate Director for Medical Affairs to act as a key liaison in... ..., ensure ethical dissemination of clinical information, and implement strategies in collaboration with colleagues.... ...project management, data analysis, and regulatory guidelines is essential. #J-18808...Regulatory
$220k - $245k
...executive leader for Quality Assurance and Regulatory Compliance in the Clinical Pharmacology Services business unit... ...candidate will influence quality strategy, manage QA teams, and ensure... ...for eligible employees, including medical, dental, vision, and 401(K). #J-18...Regulatory$58.7k - $146.8k
...integrating the patient voice into medical research and development. Our... ...; strategic consulting for regulatory needs; exploratory analyses... ...outcome (PRO) and other clinical outcome assessment (COA) solutions... ...travel possible).IQVIA is a leading global provider of clinical...RegulatoryFull timePart timeImmediate 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,...RegulatoryFull time
- ## Lead Procurement Analyst, Category ManagementApplyremote... ..., you’ll support clinical research by partnering... ...(Clinical Operations, Medical Affairs, etc.) to... ...development of sourcing strategies and improving sourcing... ...health, safety, and regulatory requirement* Ensure that...RegulatoryWork at office3 days per week
- ...Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality to...Regulatory
- Oncology Team Lead, Director Pricing & Contracting Reporting to the... ..., Pricing & Contracting Strategy, the Oncology Lead of Pricing... ...Providers, Pharmacies, Hospitals, Clinics, ASOCs etc.), mandated government... ...information (including family medical history), military service or...Long term contractContract workTemporary workLocal area2 days per week3 days per week
- ...advise developers on environmental diligence, permitting strategies, risk mitigation, and compliance across project lifecycles. The successful candidate will lead agency coordination, oversee permitting and regulatory reviews, and support financing with environmental...Regulatory
$170k - $269.8k
The Market Access Strategy Director leads global market access strategies that... ...positioning. It collaborates with medical affairs, marketing, and R&D... ...methodologies, tools, and regulatory trends Champion innovative... ...ability to synthesize clinical, economic, and policy...RegulatoryTemporary workLocal areaShift work$128.8k - $358.8k
...IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs to... ...stakeholders as needed. Lead the Target Product Label (... .... Proven ability in medical/technical writing. Labeling... ...leading global provider of clinical research services,...RegulatoryFull timeContract workPart timeLocal areaImmediate startWorldwideIQVIA
Durham, NC18 days ago- ...Clinical Nurse Leader (CN IV) Cardiology Stepdown Unit (7100) At Duke Health, we're driven... ...education needs Quality, Safety & Regulatory Support Monitor clinical practice and... ...role in advancing unit-level excellence by leading change, mentoring others, and...Regulatory16 hoursWork at officeShift workNight shift
- ...with guidelines established within the Discipline of Nursing Clinical Ladder Program and the North Carolina Board of Nursing. The position... ...: Administrative Call only CNIV Pathways Leadership/Regulatory: Monitor clinical practice and ensure compliance to practice...RegulatoryLocal areaShift workWeekend workWeekday work
- ...Health is seeking an Education Supervisor to lead onboarding, orientation, and ongoing... ...professional development and advancing clinical knowledge to improve patient care. You will... ...partner with unit leadership to ensure regulatory compliance. Prior intraoperative...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Lead Medical Writer - Clinical & Regulatory Strategy. Be the first to apply!
Related searches
- med surg medical surgical rn registered nurse Durham, NC
- medical student Durham, NC
- medical driver Durham, NC
- medical group Durham, NC
- hybrid medical Durham, NC
- medical malpractice Durham, NC
- non medical Durham, NC
- non certified medical Durham, NC
- medical collections work from home Durham, NC
- non medical in home caregiver Durham, NC