Clinical Trial Administrator ImCheck Therapeutics SASClinical Trial AdministratorCambridge, MA$67,500–$99,000 / yearResponsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US):Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system. Perform continuous oversight of the Service Provider (SP)/Ipsen TMF activities, according to Ipsen SOP.Coordinate the TMF Quality Check (as per Ipsen SOP) with the SP/Ipsen to maintain data integrity and to ensure eTMF inspection/audit readiness.
Director, Clinical Scientist Aktis Oncology IncDirector, Clinical ScientistBoston, MAAktis' most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Deliver quality study strategy and design, including analysis and interpretation of data throughout the study, including leading clinical data review with Data Management; develop and review clinical narratives; and monitor clinical data for specific trends.
NewScientific Project Coordinator Costello MedicalScientific Project CoordinatorBoston, MAManagement of project compliance, which includes completing compliance training, preparation of project compliance documentation, liaising with client compliance teams, and acting as the internal point of contact for all compliance-related queries. Assisting Project Managers with client and healthcare professional communication on multi-component projects, and the production of progress reports and summaries that enhance the level of customer service delivered.
Associate Director Medical Writing (Hybrid) Vertex Pharmaceuticals, IncAssociate Director Medical Writing (Hybrid)Boston, MA$157,600–$236,400 / yearAt Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments.
Clinical Scientist, Ophthalmology SanofiClinical Scientist, OphthalmologyCambridge, MA$148,500–$214,500 / yearThe primary purpose of the Clinical Scientist's position is to assist/support the Clinical Research Director in the medical/scientific contribution for ophthalmology clinical studies, including: supporting operational activities pertaining to protocol development (such as Informed Consent and committee charters), validation and clinical case review of study data, review of study plans and draft study reports/publications for accuracy, literature review and analysis, and preparation of responses for investigators, study teams, ethics committees, or regulatory authorities. Contribute to preparation and/or review of documents related to studies requiring scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communications to internal or external partners, study plans, study reports, trial disclosure form).
Director, Medical Writing Alkermes PlcDirector, Medical WritingWaltham, MAThe Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Associate Director, Medical Writing Alkermes PlcAssociate Director, Medical WritingWaltham, MAThe Associate Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Postdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs Northeastern UniversityPostdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory AffairsBoston, MA$60,315–$85,192.50 / yearThe fellow will have the opportunity to work collaboratively with other functional areas within Ironwood, including global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls, as well as experience partner interactions and engage in vendor oversight. Responsibilities: The purpose of the Regulatory Affairs (RA) Fellowship is to provide the fellow with training in the functional area and to prepare them to enter an industry role as an individual contributor in Global Regulatory Affairs after the end of their 2-year fellowship.
Clinical Trial Administrator Ipsen SAClinical Trial AdministratorCambridge, MA$67,500–$99,000 / yearResponsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US): Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system. Coordinate and conduct in-house and external clinical operations activities: Generate contract templates within the Ipsen dedicated system (ARIBA), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts.
Lead Statistical Programmer Karwell TechnologiesLead Statistical ProgrammerBoston, MAProvide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
NewStrategic account executive (East) Writer IncStrategic account executive (East)Boston, MAFounded in 2020 with office hubs in San Francisco, New York City, Seattle, Austin, Chicago, and London, our team thinks big and moves fast, and were looking for smart, hardworking builders and scalers to join us on our journey to create a better future of work with AI. With WRITERs end-to-end platform, hundreds of companies like Mars, Marriott, Uber, and Vanguard are building and deploying AI agents that are grounded in their companys data and fueled by WRITERs enterprise-grade LLMs.
Medical Information Specialist Integrated Resources, IncMedical Information SpecialistRaynham, MassachusettsContractormedical writing, regulatory affairs, clinical research, engineering)BS/Pharm/BSN or MS or MPH plus 2 to 3 years of relevant medical device/drug industry experience Medical Information SpecialistThe Medical Information Specialist assists in systematic literature reviews for regulatory documents by the Medical Operations Team.
Director, Medical Writing Dyne Therapeutics IncDirector, Medical WritingCambridge, MA$190,000–$235,000 / yearThis role partners closely with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs to ensure clear, consistent scientific messaging across key submissions to the FDA and global health authorities. Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials.
Lead Statistical Programmer Katalyst Healthcares & Life SciencesLead Statistical ProgrammerBoston, MAProvide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
Content Marketing - Manager / Senior Manager Veeva SystemsContent Marketing - Manager / Senior ManagerBoston, MARemote$75,000–$150,000 / yearUnlike a traditional corporation, whose only legal duty is to maximize shareholder value, PBCs consider their public benefit purpose and the interests of those materially affected by the corporation's conduct-including customers, employees, and the community-in addition to shareholders' interests. This role will create thought leadership, product-level, and customer content in close collaboration with global marketing, strategy, and sales teams to deliver impactful, high-quality content across channels and audiences.
Senior Biostatistician - Remote (US) MMSSenior Biostatistician - Remote (US)Boston, MARemoteFull timeLeads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.
Medical Director Relay Therapeutics, Inc.Medical DirectorCambridge, MAYour Role: Collaborate with senior medical staff, drug discovery teams, translational oncology, clinical operations, clinical investigators and disease-specific experts to design and execute early clinical development plans that definitively test key translational hypotheses for Relay Tx medicines and establish clinical proof-of-concept as soon as possible after entering human testing. Working cross-functionally with clinical project management, regulatory affairs, clinical operations, biostatistics, data management and medical writing, you will play a key role as Relay Tx continues to introduce product candidates into the clinic.
Scientific Director Global Medical Affairs - ATTR Alnylam Pharmaceuticals IncScientific Director Global Medical Affairs - ATTRCambridge, MA$238,800–$323,000 / yearThe role will contribute deep scientific expertise to publications strategy, investigator‑initiated studies (IIS), research collaborations, post‑hoc analyses, Phase 4 activities, and business development due diligence, with a strong emphasis on hands‑on writing, protocol development, and scientific review. The Scientific Director, Global Medical Affairs - ATTR serves as a global scientific subject matter expert supporting the ATTR franchise, with a primary focus on scientific content generation and written scientific outputs.
Consultant I, Medical Writing Syner-GConsultant I, Medical WritingBoston, MARemoteThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while maintaining strong client relationships and delivery excellence.
Medical Director Relay TherapeuticsMedical DirectorCambridge, MACollaborate with senior medical staff, drug discovery teams, translational oncology, clinical operations, clinical investigators and disease-specific experts to design and execute early clinical development plans that definitively test key translational hypotheses for Relay Tx medicines and establish clinical proof-of-concept as soon as possible after entering human testing. Working cross-functionally with clinical project management, regulatory affairs, clinical operations, biostatistics, data management and medical writing, you will play a key role as Relay Tx continues to introduce product candidates into the clinic.