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.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Medical Writing Lead for Regulatory Submissions in Billerica, MA vacancy
- ...Corporation in Billerica, MA is seeking a Senior Principal Medical Writer to lead end-to-end regulatory documentation development, ensuring scientific rigor, regulatory compliance, and timely delivery across global markets. You will mentor writers, define document...MedicalRegulatory
$192.4k - $302.39k
...best of my knowledge.Job DescriptionThe Global Medical Affairs Lead, PDT Immunology is responsible for co... ...D, Global Medical Affairs, clinical, regulatory, safety, compliance, regional and... ...strategic recommendations verbally and in writing.Credible and effective team player...MedicalRegulatoryMinimum wageLocal areaRemote workTakeda
Somerville, MA4 days ago$192.4k - $302.39k
...and empower you to shine? Join us as a Global Medical Lead, PDT Hematology (f/m/x) in our... ...Development, Clinical Science, Quality, Safety, Regulatory, Manufacturing, and Legal throughout -... ...with vendor(s) to ensure timely submission and approvalActively track, enter and...MedicalRegulatoryMinimum wageTemporary workWork experience placementWork at officeLocal areaRemote workTakeda
Somerville, MA5 days ago$212k - $333.19k
...Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...to simultaneously driving regulatory approval as well as launch... ...leader in the context of unmet medical need, competitive landscape... ...through large-scale Phase III/submission projects and global launch...MedicalRegulatoryMinimum wageWork at officeLocal areaRemote workTakeda
Somerville, MA5 days ago$154.4k - $242.55k
...Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived... ...team members in evolving submission and negotiation plans. Formulating... ...strategically interprets scientific, medical, and regulatory data and information...MedicalRegulatoryMinimum wageLocal areaTakeda
Somerville, MA5 days ago$169.4k - $266.2k
...best. As part of the Global Medical Affairs Oncology team... ...Communications Group Lead. This is a hybrid role... ..., NCCN or pathway submissions, animations, and digital... ...needsManage medical writing agency, including oversight... ...and Regulatory: Excellent understanding...MedicalRegulatoryMinimum wageFor contractorsFreelanceLocal areaRemote workTakeda
Somerville, MA2 days ago$300k - $376k
...functional CDT acting as the lead scientific expert for... ...and executes the Medical Monitoring Plan (MMP) strategy... ...sections of relevant regulatory interaction packages... ...and scientific/medical writing skills ~ Proficient in... ...CSL Behring is a global biotherapeutics leader...MedicalRegulatoryOdd jobFull timeRelocation packageFree visa$177k - $278.08k
...role, you will help shape the global commercial strategy for an... ...developments, treatment changes, regulatory pathways, and potential... ...access, insights, manufacturing, medical, regulatory, and regional teams... ....Demonstrated ability to lead globally across functions, work...MedicalRegulatoryMinimum wageLocal areaTakeda
Somerville, MA2 days ago- ...office 3 days a week.Role Summary:Reporting to the Medical Head the Senior Global Medial Affairs Lead Cardiovascular is a highly experienced Medical Affairs... ...a deep understanding of healthcare system pathways, regulatory landscapes, market access, and competitive dynamics....MedicalRegulatoryHourly payFull timeTemporary workWork at officeWorldwide3 days per week
AstraZeneca
Somerville, MA1 day ago $210.9k - $379.2k
...strategic partners worldwide, contributing to global health initiatives.Moderna's commitment... ...worldwide.Moderna is seeking a Global Medical Lead to lead medical affairs strategy across... ...role will interface extensively with regulatory, clinical, commercial, and external...MedicalRegulatoryPermanent employmentFull timeWork at officeWork from homeWorldwideModerna Therapeutics
Somerville, MA2 days ago$122.25k - $176.58k
Job title: GRA Global AdPromo Excellence LeadLocation: Morristown, NJ - Cambridge, MAAbout... ...support for global promotional material regulatory review (30%) with transversal excellence... ...through our diverse portfolio of medical device and diagnostic products. Together...MedicalRegulatoryFull timeWork at officeLocal areaWorldwideSanofi
Somerville, MA4 days ago- ...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
$212k - $333.19k
..., translating scientific, clinical, regulatory, and competitive insights into actionable... ..., and a demonstrated ability to lead in a highly matrixed global environment. You will report to the... ...organization externally at major scientific, medical, and partnering forums to identify...MedicalRegulatoryMinimum wageLocal areaRemote workTakeda
Somerville, MA5 days ago$192.4k - $302.39k
...inspire you and empower you to shine? Join us as a Director, Global Medical Lead, Zasocitinib- Psoriatic Arthritis (PsA) in our Cambridge,... ...affiliate medical teams, while recognizing local practice, access, regulatory, and stakeholder needs.Model Takeda values and a culture of...MedicalRegulatoryMinimum wageWork at officeLocal areaRemote workTakeda
Somerville, MA1 day ago$128.7k - $193k
...Associate Director, Start-up Lead, SiteID & Activation to lead... ...strategies across our global clinical trial portfolio. Key... ...feasibility assessmentsDrive regulatory submissions and site activations from protocol... ...Are:Minimum Qualifications:Medical or Life Sciences degree or...MedicalRegulatoryFlexible hoursMerck
Billerica, MA5 days ago$251k - $409.3k
...opportunity to shape how medical evidence reaches the... ...people who need it most. As Global Head of Scientific Communications, you will lead a global organization... ...medical-legal-regulatory review process. You will... ...information, or medical writing within the biopharmaceutical...MedicalRegulatoryLocal areaFlexible hoursMerck
Billerica, MA16 hours ago$321k
...as a Vice President, Global Clinical Lead - Solid Tumor in our... ...Strategy Group, Global Regulatory Affairs, Quantitative... ..., assessing the medical and scientific implications... ...Multiple NDA/MAA submission experienceProven ability... ...both verbally and in writing and influencing...MedicalRegulatoryMinimum wageWork at officeLocal areaRemote workNight shiftTakeda
Somerville, MA3 days ago$260.8k - $326k
...a clinical-stage global biopharmaceutical... ...Obexelimab, Zenas’ lead product candidate,... ...Communications, and Medical Information. In... ...professionals, researchers, regulatory authorities, and... ..., and writing vendors as needed.... ...dossiers/formulary submission dossiers.Establish...MedicalRegulatoryContract workZenas BioPharma
Waltham, MA1 day ago$115k - $130k
...About Us We are a global team of like-... ...collaborative environment leading to excellent... ...-motivated Senior Regulatory Affairs Specialist... ...regulatory planning and submission activities.... ...Clinical, R&D, Quality, Medical Affairs, and other... ...Strong technical writing, communication,...MedicalRegulatoryBrioHealth Solutions, Inc.
Burlington, MA4 days ago$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 startMerck
Billerica, MA4 days ago- ...Development to join its US-based Labelling team within Global Regulatory Affairs. You will lead the development and maintenance of Global Datasheets, manage... ...and regulatory colleagues to ensure the company’s medical position is reflected in all labeling materials, and you...MedicalRegulatory
$248.5k
...experience.CPL: Provides strategic medical guidance and leads the development of... ..., across functions, and on global projects, developing independent... ..., investigators, and regulatory authorities in oncology, and... ...oncologyExcellent medical/scientific writing skillsSuccessful track...MedicalRegulatoryFull timeWork at officeLocal areaNovartis
Somerville, MA2 days ago$148.5k - $214.5k
...Immunology Asset/Indication Lead Location: Cambridge,... ...with U.S. Medical Affairs/Value & Access... ...pipelinesAlign closely with the Global HEVA team to ensure US... ...; experience with HTA submissions strongly... ...understanding of the legal and regulatory environment of the pharmaceutical...MedicalRegulatoryFull timeContract workSanofi
Somerville, MA2 days ago$206.25k - $297.92k
...World Evidence (RWE) Strategy Lead, you will establish and execute RWE strategies across global Therapeutic Areas, translating medical needs into evidence that drives regulatory, access and medical... ...regulatory or reimbursement submissions.Use of innovative RWE methodologies...MedicalRegulatoryFull timeLocal areaSanofi
Somerville, MA4 days ago$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 hoursMerck
Billerica, MA5 days ago$200.8k - $301.3k
...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 hoursMerck
Billerica, MA3 days ago- ...MA. This role administers U.S. and global benefit programs, including medical, dental, vision, life, disability,... ..., ensuring accurate enrollment and regulatory compliance. You will analyze utilization... ...budgeting and renewals, and lead open enrollment with HRIS, payroll,...MedicalRegulatory
$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 workQdoba
Lexington, MA3 days ago- ...CSL is seeking a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products... ...deliver compliant, timely regulatory solutions. You will lead submissions, manage change controls, and interact with regulators as an...Regulatory
CSL
Waltham, MA2 days ago $132.4k - $251.6k
...problems. With our three market leading businesses, world-class... ...our RTX Corporate team: RTX Global Ethics & Compliance has an outstanding... ...and in alignment with regulatory, policy, and audit requirements... ...for stakeholders to consider Medical, dental, and vision insurance...MedicalRegulatoryContract workTemporary workWork experience placementWork at officeRemote workWork from homeFlexible hoursRTX
Tewksbury, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Medical Writing Lead for Regulatory Submissions. Be the first to apply!
Related searches
- advanced medical Billerica, MA
- medical group Billerica, MA
- non medical Billerica, MA
- medical screener reception technician Billerica, MA
- medical imaging Billerica, MA
- medical equipment delivery driver Billerica, MA
- medical authorization Billerica, MA
- part time medical Billerica, MA
- medical affairs Billerica, MA
- remote medical claims processor Billerica, MA