Global Medical Writing Lead for Regulatory Submissions
EMD Serono, Inc.
EMD Serono, Inc. is seeking a Senior Principal Medical Writer to lead end-to-end development of regulatory submission documents, ensuring scientific rigor, regulatory compliance, and timely delivery across global markets. You will serve as the primary writing lead within cross-functional teams, shaping strategy and timelines. Hybrid role based in Billerica, MA with 3 days on site. You will mentor writers, drive best practices, coordinate with clinical, regulatory, pharmacovigilance, and #J-18808-Ljbffr EMD Serono, Inc.
- ...Corporation seeks a Senior Principal Medical Writer to lead end-to-end regulatory documentation development for global programs, ensuring... ...delivery. As primary medical writing lead within cross-functional... ...will define strategies, shape submission timelines, mentor writers,...MedicalRegulatory
$115 - $135 per hour
...oncology programs and steer global regulatory strategy from concept to Health... ...regulatory sub-teams, lead critical FDA and EMA interactions... ..., and directly shape global submission pathways for cutting-edge... ...benefits package, including: medical, prescription, dental, vision...MedicalRegulatoryHourly payContract workTemporary workWork experience placementRemote work- ...Massachusetts, is looking for a regulatory professional to manage and... ...products. This role will influence global regulatory strategy and... ...regulatory affairs within the medical device sector, with a... ...relevant field. Strong technical writing and communication skills are...Regulatory
- ...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
$152k - $160k
Reporting to the GVP, Global Medical Affairs, the Manager,... ...to safety vendor, leading operations in development... ...or aggregate report submissions as well as deviations... ...of documents to regulatory agenciesSupport for investigational... ...(verbally and in writing) safety data and...MedicalRegulatoryWork at officeRemote work$178.5k - $257.83k
About the jobAs Global Clinical Development... ...flexible model. You will lead the Clinical Team... ...clinical and medical scrutiny. Ready to... ...strategy, and regulatory needs, and present... ...biostatistics, medical writing, pharmacovigilance... ..., reports), CTD submissions, and interactions...MedicalRegulatoryFull timeTemporary workFlexible hours$17 - $19 per hour
...Shift Lead Pay Range: $17 - $19 /hour The Shift Lead is... ...with 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- 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
$109.6k - $150.7k
...Inc. (NASDAQ: ADI) is a global semiconductor leader... ...for Channel Operations. Lead the Model N 2.0 Automation... ...Negative Claims submissions, POS & Inventory processing... ...operationsExcellent at writing business requirements,... ...parental status, disability, medical condition, genetic...MedicalPermanent employmentFull timeWork at officeLocal areaRelocationFlexible hoursDay shift$127.9k - $191.8k
...organization.Your Role:The Global Labeling Excellence Lead is responsible for... ...labeling activities within Regulatory Quality Safety (RQS). This... ...global labeling project plans, submission timelines, and health authority... ..., safety, quality, medical, commercial, and regional...MedicalRegulatoryLocal areaImmediate start$115k - $130k
...About Us We are a global team of like-minded... ...environment leading to excellent outcomes... ...-motivated Senior Regulatory Affairs Specialist... ...regulatory planning and submission activities. What... ..., R&D, Quality, Medical Affairs, and other... ...Strong technical writing, communication, analytical...MedicalRegulatory- ...Solutions is seeking a Senior Regulatory Affairs Specialist to support the... ...clinical, R&D, quality, and medical affairs teams to drive regulatory planning, submissions, and lifecycle management. You... ...should bring strong technical writing and project leadership. #J-188...MedicalRegulatory
$207.6k - $311.5k
...the globe.Your RoleAs a GPS Global Safety Lead, you will serve as a... ...recognized scientific authority on medical safety, shaping and driving... ...managed in alignment with regulatory requirements and internal... ...safety input into regulatory submission documents such as the...MedicalRegulatoryFlexible hours$174.6k - $262k
...in the US. Your Role:As a Medical Director in Global Clinical Development... ...environment.Key Accountabilities:Lead assigned clinical studies... ...-enabling activities, regulatory submissions, and Health Authority... ...Operations, Safety, and Medical Writing. Support study design,...MedicalRegulatoryWork at officeFlexible hours$126.9k - $215.4k
...Senior Principal Medical WriterAs the Senior Principal... ...Writer, you will lead the end-to-end development of complex regulatory submission documents – ensuring high... ...as the primary medical writing lead within cross-... ...medical writing efforts for global, priority programs...MedicalRegulatoryLocal areaImmediate startRemote work$242.25k - $403.75k
...Director, Portfolio Integration Lead - HematologyDescriptionFor... ...to candidates from either a medical or non-medical background... ...Research & Development (R&D), Global Medical Affairs (GMA) and... ...health authority interactions, regulatory submissions and key development...MedicalRegulatoryFull timeLocal areaRemote workWork from homeRelocation$248k - $280k
...visit Position Purpose: The Director, Global Regulatory Strategy will be responsible for... ...regulatory strategy. Oversee preparation and submission of global regulatory submissions to... ...variety of senior personnel including medical, scientific, and manufacturing staff....MedicalRegulatoryTemporary work$134.64k - $201.97k
...NASDAQ: ADI) is a global semiconductor leader... ...Engineer - Medical DevicesThe Health... ...Cybersecurity Engineer to lead cybersecurity... ...security, privacy, and regulatory compliance of... ...supporting FDA regulatory submissions, including 510(k)... ..., technical writing, communication, and...MedicalRegulatoryPermanent employmentFull timeWork at officeDay shift$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- ...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$126.9k - $215.4k
...Role As the Senior Principal Medical Writer, you will lead the end-to-end development of complex regulatory submission documents—ensuring high... ...Acting as the primary medical writing lead within cross-... ...medical writing efforts for global, priority programs across the...MedicalRegulatoryRemote work- Anika is seeking a Senior Complaint Specialist to manage global medical device complaints in a highly regulated environment from Bedford,... ...will oversee intake, investigation, MDR determinations, and regulatory reporting to ensure compliant, timely, and well-documented outcomes...Regulatory
$185k - $210k
...Description The US Regulatory Strategy lead is responsible for all aspects... ...a critical member of the Global Regulatory Team (GRT) providing... ...to FDA Contributes to Submission Taskforce meeting and... ...growth. A comprehensive medical, dental, and vision package...MedicalRegulatoryOdd jobFull timeTemporary workWork experience placement- ...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
- ...Lead Clinical Data Manager A Few Words About Us Integrated... ...management processes, as well as global regulatory and industry rules and... ...processes and global project submissions through to approval. Responsibilities... ...organizations, CROs and the medical community. · Proven...MedicalRegulatoryContract workFor contractorsImmediate start
$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$90.9k - $131.8k
...hundreds of communities globally. Our purpose is to... ...design work, calculations, writing specifications and... ...deliverable packages for submission to clients and/or... ...as well as client and regulatory agencies standards and... ...week) have access to medical, dental, and vision plans...MedicalRegulatoryFull timeContract workTemporary workPart timeCasual workLive inWork at officeLocal areaFlexible hours- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with cross...RegulatoryFull time
- ...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
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