Global Regulatory Medical Writing Lead
Biopharma Careers
Biopharma Careers in the United States is seeking a Senior Principal Medical Writer to lead end-to-end development of complex regulatory submission documents across international markets. You will define strategy, timelines, and align cross-functional teams in clinical, regulatory affairs, pharmacovigilance, and statistics. You will mentor writers, drive consistency, and ensure high quality deliverables while navigating global submissions for multiple programs in a hybrid work arrangement in #J-18808-Ljbffr Biopharma Careers
- ...Serono, Inc. is seeking a Senior Principal Medical Writer to lead end-to-end development of regulatory submission documents, ensuring... ...compliance, and timely delivery across global markets. You will serve as the primary writing lead within cross-functional teams, shaping...MedicalRegulatory
- Millipore Corporation seeks a Senior Principal Medical Writer to lead end-to-end regulatory documentation development for global programs, ensuring scientific rigor, quality, and timely delivery. As primary medical writing lead within cross-functional teams, you will define...MedicalRegulatory
$115 - $135 per hour
...high-stakes oncology programs and steer global regulatory strategy from concept to Health... ...cross-functional regulatory sub-teams, lead critical FDA and EMA interactions, and... ...comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and...MedicalRegulatoryHourly payContract workTemporary workWork experience placementRemote work- ...Inc. in the United States seeks a GPS Global Safety Lead to steer integrated safety strategies... ...risk management, and collaborate with regulatory bodies and cross-functional teams to ensure... ...lifecycle. The role requires a medical or pharmacy degree with 5+ years in drug...MedicalRegulatory
$100k - $186.3k
...Director to support and help lead operations of our state-of-the... ..., including other Harvard Medical School-affiliated hospitals.... ...Support: Contribute to grant writing, progress reports, and high-impact... ...: Ensure adherence to regulatory, ethical, and institutional guidelines...MedicalRegulatory- Biopharma Careers is seeking a Global Labeling Excellence Lead to advance operational excellence across global labeling activities within Regulatory Quality Safety. You will partner with process owners to implement compliant, scalable labeling processes and apply change...Regulatory
$152k - $160k
Reporting to the GVP, Global Medical Affairs, the Manager, Global Medical... ...to safety vendor, leading operations in development of... ...submissions of documents to regulatory agenciesSupport for investigational... ...communicate (verbally and in writing) safety data and clinical/pharmaceutical...MedicalRegulatoryWork at officeRemote work$17 - $19 per hour
...POSITION SUMMARY: The Shift Lead is responsible for executing... ...policies, procedures, and regulatory requirements. KEY DUTIES/RESPONSIBILITIES... .... Fundamental reading, writing, math and computer/POS skills... ...$19/hour Benefits: Medical, Dental, Vision, & 401k for...MedicalRegulatoryLocal areaShift workWeekend work$185.8k - $278.6k
...and career advancement across the globe.Your Role: As a Medical Director within the Global Medical Unit, you will serve as a key scientific leader responsible... ...in close partnership with the Global Medical Strategy Lead and a broad network of internal and external stakeholders...MedicalFlexible hours$178.5k - $257.83k
About the jobAs Global Clinical Development Strategy... ...flexible model. You will lead the Clinical Team to... ...the highest clinical and medical scrutiny. Ready to get... ...franchise strategy, and regulatory needs, and present for... ...biostatistics, medical writing, pharmacovigilance, regulatory...MedicalRegulatoryFull timeTemporary workFlexible hours- ...clients in transforming their technologic and regulatory processes to enhance the safety,... ...national challenges.Excellent analytic writing and verbal/presentation skills to senior... ...is expected.Research experience with the global financial system.Ability to bridge finance...RegulatoryWork experience placementLocal area
$134.2k - $202.2k
...the organization.Your Role:The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized product labeling in... ...information (PIs), and global packaging text in compliance with regulatory standards. The LPL supports country regulatory affairs...RegulatoryLocal areaImmediate startWorldwide- Skills Alliance Enterprise is seeking an experienced Regulatory Affairs professional to lead global project teams for assigned oncology programs, driving regulatory submissions from planning through approval. You will chair the GRST, coordinate interactions with FDA/EMA...RegulatoryRemote job
- EMD Electronics is seeking an Inspection Management Lead to coordinate multi-site GCP/GVP regulatory inspections within Healthcare R&D. The role requires leading... ...in inspection readiness. You will oversee a global inspection process, manage communications, and report...Regulatory
- ...quality standards working with Sales, Finance, IT, CRM, and ERP globally. You will lead initiatives around Lead-to-Order and Order-to-Cash,... ...Lead Management, Invoicing, and Master Data while balancing regulatory requirements and regional needs. #J-18808-Ljbffr...Regulatory
$140k - $160k
A global diagnostics leader seeks a QA Manager in Bedford, Massachusetts. This role involves... ...timely investigations, and adhering to regulatory standards. Ideal candidates should... ...experience in quality management within medical diagnostics. The position offers a competitive...MedicalRegulatory$109.6k - $150.7k
...Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that... ...owner for Channel Operations. Lead the Model N 2.0 Automation program... ...operationsExcellent at writing business requirements, functional... ...parental status, disability, medical condition, genetic information...MedicalPermanent employmentFull timeWork at officeLocal areaRelocationFlexible hoursDay shift- ...Overview:The Senior Counsel, Global Compliance, Competition & Trade... ...embed controls, anticipate regulatory developments, and share best... ...to election and eligibility: Medical, Dental, Vision, Disability,... ...Dr Pepper (Nasdaq: KDP) is a leading beverage company with more than...MedicalRegulatory
$127.9k - $191.8k
...outside of the organization.Your Role:The Global Labeling Excellence Lead is responsible for advancing... ...across global labeling activities within Regulatory Quality Safety (RQS). This role... ...partnering with regulatory, safety, quality, medical, commercial, and regional...MedicalRegulatoryLocal areaImmediate start- ...Human Rights Office within the Global Compliance team, supporting... ...operations and the value chain. Leads the implementation,... ...and other applicable legal and regulatory requirements.This individual... ...Transparency Request FormFresenius Medical Care is an equal opportunity...MedicalRegulatoryFull timeWork at officeRemote workWork from home
- ...:The Construction Management Lead - Clinics is responsible for... ...cost efficiency, quality, and regulatory compliance.This leader oversees... ...timelines.Partner with the Global Real Estate Center of Excellence... ...Request FormFresenius Medical Care is an equal opportunity...MedicalRegulatoryFull timeFor contractorsLocal areaRelocationNight shift
- ...The role involves close collaboration with the Medical Lead on interpretation of data, study designs, and regulatory documents. You will conduct medical monitoring and... ..., oversee vendor monitoring, and work with a global, multidisciplinary team to integrate complex data...MedicalRegulatory
$115k - $130k
...Annually About Us We are a global team of like-minded... ...environment leading to excellent outcomes.... ...self-motivated Senior Regulatory Affairs Specialist to... ...Clinical, R&D, Quality, Medical Affairs, and other cross... ...changes. Strong technical writing, communication,...MedicalRegulatory- BrioHealth Solutions is seeking a Senior Regulatory Affairs Specialist to support the... ...partners with clinical, R&D, quality, and medical affairs teams to drive regulatory planning... ...Candidates should bring strong technical writing and project leadership. #J-18808-Ljbffr...MedicalRegulatory
- Lantheus Medical Imaging Inc seeks an Associate Director of 3PL Operations to lead cold chain and radioactive pharmaceutical logistics, focusing on third-party providers to ensure quality, regulatory compliance, and efficiency. The role requires on-site presence in Massachusetts...MedicalRegulatory
$207.6k - $311.5k
...advancement across the globe.Your RoleAs a GPS Global Safety Lead, you will serve as a recognized scientific authority on medical safety, shaping and driving integrated... ...and strategically managed in alignment with regulatory requirements and internal governance standards...MedicalRegulatoryFlexible hours$134.2k - $202.2k
...across the globe. Your Role The Associate Director of Global Labeling / Labeling Product Lead (LPL) ensures globally harmonized product labeling in... ...information (PIs), and global packaging text in compliance with regulatory standards. The LPL supports country regulatory affairs...RegulatoryLocal areaWorldwideFlexible hours$229.8k - $381.7k
...globe.Your role: In your role as Global Program Head (GPH), you hold... ...or clinical area. You will lead one or more Global Program... ...development, securing global regulatory approvals, ensuring market access... ...significant scientific or medical knowledge. You should have a...MedicalRegulatoryFlexible hours3 days per week$174.6k - $262k
...in the US. Your Role:As a Medical Director in Global Clinical Development Oncology... ....Key Accountabilities:Lead assigned clinical studies and... ...registration-enabling activities, regulatory submissions, and Health... ..., Safety, and Medical Writing. Support study design, dose...MedicalRegulatoryWork at officeFlexible hours$248k - $280k
...For more information, visit Position Purpose: The Director, Global Regulatory Strategy will be responsible for developing and delivering... ...to effectively manage a variety of senior personnel including medical, scientific, and manufacturing staff. Well organized, self-motivated...MedicalRegulatoryTemporary work
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