Senior Medical Writing Lead for Regulatory Submissions
BioSpace, Inc.
Lilly is seeking an Associate Director-Medical Writer to lead and drive the development of high-quality regulatory and scientific documents for submissions and internal communications. You will coordinate with clinical development, regulatory, biostatistics, medical affairs, and legal teams to ensure accuracy and regulatory compliance. The role requires 8+ years in medical writing within pharma/biotech/CRO, advanced degree preferred, and strong mentoring abilities. #J-18808-Ljbffr BioSpace, Inc.
- Alnylam Pharmaceuticals is looking for a Senior Manager, Medical Writing to join our team in Cambridge, Massachusetts. This role involves... ...years of medical writing experience, familiarity with regulatory submissions, and excellent project management skills. A comprehensive...SeniorMedicalRegulatoryContract work
- ...Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee... ...across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorMedicalRegulatoryContract work
- Agomab Therapeutics seeks a Senior Director of Medical Writing to anchor our hybrid medical writing... ...will balance AI-enabled tools with regulatory rigor, partnering with... ...development story and ensure audit-ready submissions. You will lead CRO relationships, set standards...SeniorMedicalRegulatoryRemote job
- Precision AQ is seeking a Senior Medical Editor to lead editorial quality for pharmaceutical client materials... ..., ensuring AMA style, accuracy, and regulatory alignment. You will collaborate with... ...style guides, and support MLR submissions while maintaining tight deadlines...SeniorMedicalRegulatory
$150k - $200k
A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages... ...7 years of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from...MedicalRegulatory- MMS is an innovative CRO focused on regulatory-grade trial data and submissions. The Medical Writer will evaluate literature, draft protocols, summaries, and regulatory... ...candidates have 3+ years in pharma regulatory writing, strong MS Word skills, and proven leadership in...MedicalRegulatory
$105.8k - $175k
...impact We are seeking a Senior Environmental Permitting Lead to drive the successful planning... ...permitting strategy, regulatory interface, and high-... ...departments. Strong technical writing, editing, and... ...Employees have access to medical, dental, vision, and basic...SeniorMedicalRegulatoryFull timeLocal areaRemote workShift work- Synterex, Inc. is seeking a senior medical writer to lead planning and preparation of high-quality regulatory documents within our medical writing team. You will partner across Clinical Development, Regulatory, and Program Management to deliver protocols, study reports...SeniorMedicalRegulatoryRemote job
$137.2k - $205.8k
Vertex Pharmaceuticals in Boston is looking for a Medical Writing Science Senior Manager to independently author complex clinical study... ...remote work two days a week, ensuring flexibility while leading critical regulatory writing activities. The ideal candidate will have at...SeniorMedicalRegulatoryRemote work2 days per week- Vertex Pharmaceuticals Incorporated is seeking a Medical Writing Science Senior Manager to author complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. The role supports cross-functional teams and may...SeniorMedicalRegulatoryWork at officeRemote workFlexible hours2 days per week
$230.9k - $384.8k
...role of the Global Medical Evidence Strategy Lead within the COVID-19... ...efficiency in support of regulatory requirements, public... ...or overseeing the writing of the first draft... ...support regulatory submissions and decision making... ...following: Lead or senior author of ≥ 5 peer-reviewed...SeniorMedicalRegulatoryPermanent employmentWork experience placementSeasonal workH1bLocal areaVisa sponsorshipWork visaRelocation package- Costello Medical is seeking an experienced clinical... ...for Boston, the role leads setup and delivery of... ...management tasks. As a senior member, you will manage... ...-end, oversee IRB/IEC submissions, budgets, and collaboration... ...while upholding regulatory and #J-18808-Ljbffr Costello...SeniorMedicalRegulatory
$212k - $333.19k
...you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...to simultaneously driving regulatory approval as well as launch... ...in the context of unmet medical need, competitive landscape... ...through large-scale Phase III/submission projects and global...SeniorMedicalRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- A biotechnology company in Cambridge, MA is looking for a Senior Director of Biostatistics to lead statistical activities for clinical programs, provide input during regulatory submissions, and mentor junior statisticians. This role demands expertise in statistical analysis...SeniorRegulatory
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule. You will manage a portfolio of submissions...SeniorRegulatory
- ...the Cambridge/Durham area seeking a Senior Analyst, Statistical Programming to lead programming activities and oversee vendor work, delivering submission-ready outputs with minimal... ...and ensure compliance with CDISC and regulatory guidelines across trials. #J-18808...SeniorRegulatory
- ...join the team as our Senior Director, Clinical Sciences... ...Development.Your Role:Lead, mentor, and develop a... ..., Pharmacovigilance, Regulatory Affairs, Translational Medicine, and Medical Writing to ensure high-quality... ...to regulatory submissions and health authority interactionsEnsure...SeniorMedicalRegulatory
- Agomab Therapeutics is seeking a Senior Director of Medical Writing to lead the regulatory writing function across multiple programs. This strategic role embeds... ...strategy, improve document quality, and ensure submission readiness. The role emphasizes AI-enabled tools, cross...SeniorMedicalRegulatory
- ...in the United States is seeking a Clinical Regulatory Writing Associate Director to lead complex regulatory writing across drug development... ...teams to ensure timely, compliant submissions. The role requires extensive medical writing experience in pharma or CROs, strong...MedicalRegulatory
- Talent Groups seeks a Senior Medical Writer to lead medical writing activities for clinical and regulatory submissions in a hybrid Boston environment. You will independently author complex clinical and regulatory documents and coordinate regulatory filings across MAAs....SeniorMedicalRegulatory
$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - Hematology Overview Cancer is unrelenting, but so... ...functional stakeholders in R&D, Global Medical Affairs, and Global Product... ...health authority interactions, regulatory submissions and key development milestones across...SeniorMedicalRegulatoryLocal areaRemote workWork from home$95k - $115k
...Senior Proposal Lead SMMA is seeking an experienced Senior Proposal Lead... ...opportunity identification through submission, helping position SMMA for... ...proposal content. Write, edit, and tailor proposal narratives... ...-funded MA Paid Family and Medical Leave ~401(k) with company...SeniorMedicalWork from home- Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives... ...collaborate across Regulatory Affairs, Medical Writing, Clinical Development, CMC, and Quality...SeniorMedicalRegulatory
- ...health issues today and address the medical challenges of tomorrow. We... ...and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is... ...preparation and review of regulatory submissions consistent within US and Canada...SeniorMedicalRegulatoryLocal area
- ...you to apply to our Senior Cyber Incident... ...privacy incidentsTaking lead responsibility in... ...to regulatory investigations arising... ...plusExcellent research, writing, and communication... ...match, and robust medical, dental, vision, life... ...Elser welcomes submissions of candidates for...SeniorMedicalRegulatoryWork at officeRemote workFlexible hours
- MMS Holdings Inc in Boston is seeking a Medical Writer to evaluate medical literature... ...role requires at least 3-5 years of regulatory writing experience in the pharmaceutical industry... ...members and ensuring high-quality submissions to regulatory authorities. #J-18808-Ljbffr...SeniorMedicalRegulatoryRemote job
$150k - $200k
Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma... ...across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership and...MedicalRegulatoryWorldwide- A leading pharmaceutical company is looking for a Medical Writing Operations Manager to ensure high-quality, submission-ready documents. The role includes reviewing and formatting documents... ...field and at least 4 years of regulatory document experience in biotech or pharma...SeniorMedicalRegulatoryContract work
- ...pharmaceutical, biotech, and medical device industries with a... ...approach to complex trial data and regulatory submission challenges. With a global... ...rigor and absence of bias Write and edit clinical development... ...study protocol experience, as lead author, required Experience...SeniorMedicalRegulatoryRemote workWorldwide
$132.3k - $245.7k
...CambridgeInternal Title: Senior Principal Scientist... ...to develop and lead fit-for-purpose imaging... ...clinical protocol writing across line functions... ...plus. Experience in regulatory interactions, submissions, first-in-human... ...disabilities. If, because of a medical condition or...SeniorMedicalRegulatoryFull time
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