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.
- ...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
$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$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$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$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$221.6k - $305.4k
...Position Scope:The Executive Director, Global Regulatory Affairs oversees the regulatory... ...globally, ensuring timely submissions and successful approvals while leading and developing a high-performing... ...clinical, CMC, pharmacovigilance, medical affairs) to enable successful...MedicalRegulatoryFlexible hours3 days per week$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$100 - $120 per hour
...experience Take full ownership of global regulatory strategy for critical... ...role. As Global Regulatory Lead, you will direct FDA and EMA... ...and steer major submissions through to approval to bring... ...benefits package, including: medical, prescription, dental, vision...MedicalRegulatoryHourly payContract workTemporary workWork experience placementRemote work$221.6k - $305.4k
Position Scope The Senior Director, Global Regulatory Affairs oversees the regulatory... ...globally, ensuring timely submissions and successful approvals while leading and developing a high-performing... ...clinical, CMC, pharmacovigilance, medical affairs) to enable successful program...MedicalRegulatory3 days per week$140k - $216.9k
...understanding of market trends, regulatory drivers, and clients need to... ...across the region.Lead technical delivery of wastewater... ...communications and technical proposal writing.Committed to Health, Safety... ...per week) have access to medical, dental, and vision plans, a...MedicalRegulatoryFull timeTemporary workPart timeCasual workLocal areaFlexible 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$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
$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$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- Symbotic is seeking a Trade Compliance Lead to define, lead, and scale the company’s global trade compliance program across regions. This role will embed compliance... ...supply chain execution, ensuring alignment with regulatory requirements and business growth. You will own...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$148k - $222k
...Associate Director, Medical Writer Location:... ...scientific writing expertise and ensure... ...publications and submission documents. This role... ...: Coordinate and lead the review, approval... ...quality across all regulatory and scientific documents... ...Stay abreast of global regulatory...MedicalRegulatory$126.9k - $215.4k
...Senior Principal Medical WriterWork Your Magic with... ...Medical Writer, you will lead the end-to-end development of complex regulatory submission documents – ensuring... ...as the primary medical writing lead within cross-... ...medical writing efforts for global, priority programs...MedicalRegulatoryRemote workFlexible hours$221.6k - $305.4k
EMD Serono, Inc. is seeking a Senior Director, Global Regulatory Affairs to oversee regulatory strategy for multiple oncology programs. The role includes leading global submissions, managing a regulatory team, and aligning regional plans with program milestones. The ideal...Regulatory$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- ...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
$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$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- 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
- ...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
$229.8k - $381.7k
...to: Provide medical leadership across... ...centric development. Lead clinical... ...Safety, Biostats, Regulatory, Quality, Medical... ...Support regulatory submissions and interactions (... ...leadership across global cross-functional teams... ...~ Strong medical writing and document review...MedicalRegulatoryLocal areaImmediate startShift work$229.8k - $381.7k
...to: Provide medical leadership across... ...centric development. Lead clinical... ...Safety, Biostats, Regulatory, Quality, Medical... ...Support regulatory submissions and interactions (... ...leadership across global cross-functional teams... ...~ Strong medical writing and document review...MedicalRegulatoryFlexible hours3 days per week$251.61k - $377.42k
...Global Product Leader, Late CVRM – Weight ManagementAre you an inspiring... .... In this role, you'll lead a cross-functional Global... ...product, including publications, regulatory documents, and clinical trial... ..., health benefits including medical, prescription drug, dental, and...MedicalRegulatoryHourly payFull timeTemporary workPart time
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