Senior Clinical Regulatory Strategist — Hybrid
Iterative Scopes
Iterative Health is seeking a Senior Clinical Regulatory Specialist to support compliant execution of Phase 2–4 industry-sponsored trials across our network. You will provide regulatory guidance and oversight from startup through closeout, partnering with sites, sponsors, CROs, IRBs, and internal teams to ensure timely, compliant submissions. The role emphasizes independent management of multiple studies, strong knowledge of GCP and FDA regulations, and driving process improvements for ongoing #J-18808-Ljbffr Iterative Scopes
- 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....SeniorRegulatory
$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ...environment. This position is on-site or hybrid and is not eligible for a fully... ...compliance across clinical programs.Support regulatory agency inspections at Vertex and/or...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week- DeepHealth is seeking a Senior Clinical Data Analyst to independently execute clinical studies activities, managing complex imaging datasets... ...and cross-functional teams to ensure data integrity and regulatory compliance across sites. The role involves developing documentation...SeniorRegulatoryRemote job
- ...product, and underwriting strategies. You will lead cross-functional teams, oversee end-to-end lifecycle management, and ensure regulatory compliance to deliver customer-focused product innovations. The role emphasizes collaboration with leaders and SMEs to implement...SeniorRegulatory
- Alkermes is seeking a Senior Manager of Regulatory Affairs to guide regulatory strategies for new product development and clinical progression, reporting to the Head of Orexin Regulatory... ...and responses to authorities, with a hybrid work model and onsite presence in Waltham...SeniorRegulatory
- Boston Children's Hospital is seeking a Billing Compliance Auditor III (hybrid) to audit clinical documentation and coding for regulatory compliance. The role involves analyzing medical records and billing records, preparing reports, and advising physicians and departments...SeniorRegulatory
- ...Statistical Programmer to develop SAS programs for clinical trial reporting. You will create TLFs, LS, and data sets, ensuring regulatory compliance and efficiency through reusable... ...with CROs to support FDA submissions. Hybrid in-office/remote work is offered in the Cambridge...SeniorRegulatoryWork at officeRemote work
- RadNet is seeking a Senior Clinical Studies Associate in Somerville, Massachusetts, to support... ...developing study documentation, ensuring regulatory compliance, and managing project... ...skills. The position allows for remote, hybrid, or office work. #J-18808-Ljbffr RadNetSeniorRegulatoryWork at officeRemote work
- ...Inc. in Needham/Boston, MA seeks a Senior Manager, Trial Operations to lead Phase... ...start-up to closeout. Partners with Clinical Development, CMC, Regulatory Affairs and external vendors to... ...and cross-functional leadership in a hybrid, on-site/remote environment based in...SeniorRegulatoryRemote job
- ...an imaginative Sr. Medical Director in Clinical Research within the Cardiovascular & Metabolism... ...clinical feasibility insights. This hybrid position is located at Alnylam's... ...development experience and a strong background in regulatory interactions. #J-18808-Ljbffr Alnylam...SeniorRegulatory
- ...Inc. is seeking an experienced Senior Manager/Associate Director,... ...Control to lead QC activities for clinical and commercial drug... ...standards, investigations, and regulatory collaboration. Based in either... ...office in USA), the role is hybrid with two onsite days weekly minimum...SeniorRegulatoryWork at office
- Vertex Pharmaceuticals seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP... ...for assigned trials. This on-site or hybrid role requires hands-on experience... ...to 10% travel and a strong focus on regulatory #J-18808-Ljbffr Vertex PharmaceuticalsSeniorRegulatory
- ...company powering the acceleration of clinical research to transform patient outcomes... ...with 250+ employees world-wide.As a Senior Clinical Regulatory Specialist at Iterative Health, you will... ...— professionally and personally.Hybrid work environment with in-office collaboration...SeniorRegulatoryTemporary workWork at office2 days per week
- Job DescriptionGeneral Summary:The Senior Director, Clinical Pharmacology will serve as a Disease Area... ...clinical studiesExperience with regulatory agency interactions including written... ...k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week
- Summary of Key Responsibilities:Clinical pathology assessment of preclinical results for... ...clinical pathology reports and/or reviews for regulatory filingsConsult with other internal and... ...for essential company activities Onsite/hybrid role in Cambridge, MA#LI-JR1U.S. Pay...SeniorRegulatoryFull timeTemporary workLocal areaFlexible hours
$274.5k
Job SummaryThe Senior Medical Director provides clinical development expertise for late-stage thoracic oncology... ...closely with other functions such as regulatory affairs, pharmacovigilance,... ...assistance may be providedThis is a hybrid role requiring you to live within commuting...SeniorRegulatoryPermanent employmentFull timeInternshipH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...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... ...and program-level activities. The position is hybrid, with 2 days remote per week and 3 days in the...SeniorRegulatoryWork at officeRemote workFlexible hours2 days per week
- ...Job DescriptionGeneral Summary:The Senior Medical Director will define the clinical development strategy of an asset,... ...in the preparation of regulatory documents in support of regulatory... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week
$236.25k - $393.75k
Job Title: Senior Clinical Research DirectorLocation: Cambridge, MA About the JobJoin the engine... ...Project Head, PV Representatives, Regulatory, and other key functional representativesClinical... ...protected by law. #GD-SA #LI-SA #LI-Hybrid#vhd Pursue progress, discover...SeniorRegulatoryFull time- ...Summary:The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of... ...program-level activities.This is a hybrid role which allows for 2 days per week...SeniorRegulatoryFull timeSummer workWork at officeRemote workFlexible hours2 days per week3 days per week
$305.7k - $413.7k
...is an opportunity to provide clinical leadership in developing RNAi... ...clinical development programs.The Senior Director, Clinical Research,... ...a matrix organization across Regulatory, Biostatistics, Clinical... ...scientific meetings.This position is hybrid and will be primarily located...SeniorRegulatoryFull timeTemporary workLocal areaFlexible hours- Frontier Medicines seeks two Clinical Trial Managers to lead day-to-day execution of oncology trials, reporting... ...-up, maintenance, and close-out while ensuring regulatory compliance and TMF quality. The role is hybrid in Boston, MA with 2-3 days onsite and periodic travel...Regulatory
- Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-impact leader who will... ...directly to the CEO. Boston-based, hybrid with a min of 2-3 days in office Key... ...and evaluate emerging industry trends, regulatory innovation pathways, and operational...SeniorRegulatoryWork at office
$99k - $167k
...approaches. •Extensive knowledge of market research and marketplace and regulatory trends. •Extensive knowledge and understanding of product... ...for this position unless specified in the postingIn this hybrid role, you will be expected to work a minimum of 10 days per month...RegulatoryFull timeLocal areaRelocation package$257.6k - $404.8k
...your future at Takeda. Join us as a Senior Medical Director, Clinical Science Neuroscience, in our Cambridge... ...the medical, scientific, regulatory and commercial issues for assigned Takeda... ...position is currently classified as “hybrid” in accordance with Takeda’s Hybrid...SeniorRegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workNight shift- ...OverviewBicara Therapeutics is seeking a Senior Clinical Trial Manager (Global) to oversee... ...based in our Boston office and follows a hybrid schedule, with three in-office days each... ...to and/or author clinical sections of regulatory documents including Investigators’ Brochures...SeniorRegulatoryFull timeTemporary workWork at officeLocal area3 days per week
- Wayfair is seeking a Senior Analyst for the Sales Compensation team in Boston to design, optimize, and administer incentive plans that... ...automate pipelines, deliver actionable insights, and drive cross-functional impact in a hybrid Boston-based role. #J-18808-Ljbffr WayfairSenior
$140k - $175k
...this isn't it.The RoleWe're looking for a Senior Clinical Trials Manager who will own the end-to-... ...of our clinical studies, including regulatory trials. This is a hands-on, operationally... ...RWE) study designs and decentralized / hybrid clinical trial models.Prior experience...SeniorRegulatoryFull timeContract workImmediate startWorldwideNight shift- Nixon Peabody LLP is seeking a Media Relations Senior Specialist to develop and execute integrated PR strategies that raise the firm’s... ...transactional work, pro bono, and firmwide initiatives. The role sits in a hybrid environment and requires building strong relationships with...Senior
- ..., shape policies, and collaborate with General Counsel and risk teams. This role emphasizes cross‑functional leadership, integrity, and innovation, with a hybrid schedule and a 35‑hour work week. #J-18808-Ljbffr Harvard Central Administration (CADM) Talent AcquisitionSeniorContract work
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