MyOmeNewScientific/Medical Writer MyOmeScientific/Medical WriterBoston, MARemote$100,000–$140,000 / yearWe combine clinical-grade whole genome sequencing, advanced AI methods for genome interpretation, and seamless digital tools for doctors and patients to order and access results. An early-stage biotechnology/genetics firm is seeking a full-time Scientific/Medical Writer to research, write, and edit the company's scientific reports.
Kiniksa Pharmaceuticals International PlcPrincipal Medical Writer Kiniksa Pharmaceuticals International PlcPrincipal Medical Writerlexington, MA$178,000–$189,000 / yearThe ideal candidate will bring strategic insight, scientific rigor, and cross-functional collaboration to ensure timely and compliant delivery of key documents that support our innovative pipeline. Responsibilities (including, but not limited to): Author, review, and manage a broad range of documents including: Clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs).
Daley and AssociatesMedical Technical Writer Daley and AssociatesMedical Technical WriterBoston, MA$40–$45 / hourThe ideal candidate will have 3-5+ years of technical writing experience within life sciences, with specific experience supporting medical devices and/or IVD products. The Technical Writer will be responsible for developing, revising, and maintaining high-quality technical documentation across multiple product lines.
MindlanceIT - Technical Writer 2 MindlanceIT - Technical Writer 2Boston, MARemoteSummary: The main function of a Technical Writer is to write technical materials, such as equipment materials, appendices, or operating and maintenance instructions. May be asked to troubleshoot complex problems and engages others in problem-solving strategies to identify practical and effective solutions to complex issues.
StratAcuity Staffing Partners IncNewVigilance Writer StratAcuity Staffing Partners IncVigilance WriterActon, MARemote$40–$46 / hourThe Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.
StratAcuity Staffing Partners IncTechnical Writer StratAcuity Staffing Partners IncTechnical WriterLexington, MA$35–$40 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
LancesoftVigilance Writer LancesoftVigilance WriterActon, MARemote$43The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements;serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities;works on problems of diverse scope where analysis of data requires evaluation of identifiable factors;demonstrates good judgment in selecting methods and techniques for obtaining solutions;and networks with senior internal and/or external personnel in own area of expertise. Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.
Dana-Farber Cancer Institute IncScience Writer Dana-Farber Cancer Institute IncScience WriterBOSTON, MARemote$80,100–$103,200 / yearHe/she will work with the Senior VP of Communications, the directors of Editorial and Creative Services and Media Relations, as well as other Communications Department staff and DFCI senior administrators, to formulate and produce articles and publicity materials that promote understanding and support for Dana-Farber's research and clinical mission. Write, ghost write, and edit materials for a wide array of non-publication projects, including letters, memos, scientific symposia, research seminars, organizational changes within DF/HCC, trends in research and care.
Brigham and Women's HospitalNewSenior Manager and Academic Writer/Editor for Faculty Development Brigham and Women's HospitalSenior Manager and Academic Writer/Editor for Faculty DevelopmentBoston, MA$63,648–$90,750.40 / yearPhysical RequirementsStanding Occasionally (3-33%) Walking Occasionally (3-33%) Sitting Constantly (67-100%) Lifting Occasionally (3-33%) 20lbs - 35lbs Carrying Occasionally (3-33%) 20lbs - 35lbs Pushing Rarely (Less than 2%) Pulling Rarely (Less than 2%) Climbing Rarely (Less than 2%) Balancing Occasionally (3-33%) Stooping Occasionally (3-33%) Kneeling Rarely (Less than 2%) Crouching Rarely (Less than 2%) Crawling Rarely (Less than 2%) Reaching Occasionally (3-33%) Gross Manipulation (Handling) Constantly (67-100%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%). The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success.
Daley and AssociatesTechnical Writer - Med Device Daley and AssociatesTechnical Writer - Med DeviceBoston, MA$40–$45 / hourCreate and manage technical documentation using MadCap Flare, utilizing condition tags, variables, snippets, content reuse strategies, and multichannel publishing outputs (with a focus on PDF publishing). This role is responsible for developing, updating, and maintaining technical content, producing multi-channel outputs with a strong focus on PDF publishing, and collaborating with cross-functional teams.
CVS Health CorpSenior Document Writer CVS Health CorpSenior Document WriterMA$18.50–$42.35 / hourOur teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong. At CVS Health, you'll be surrounded by passionate colleagues who care deeply, innovate with purpose, hold ourselves accountable and prioritize safety and quality in everything we do.
IBSS CorporationNewTechnical Writer II IBSS CorporationTechnical Writer IIGloucester, MARemote$68,000–$72,000 / yearThe TDM division is responsible for providing web and mobile based applications, technical services and support for approximately 16,000 internal and external customers (fisheries management councils, state and USCG law enforcement, state fisheries management and other fishery management groups, and commercial fishing industry users). If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to the Talent Acquisition department at Recruiting@ibsscorp.com.
Veterans Inc.Grant Writer Veterans Inc.Grant WriterWorcester, MAThe Grant Writer is a key member of the Development team and is responsible for researching, developing, and writing proposals, concept papers, grant solicitations, and other written materials to secure funding for program support and capital projects. Veterans Inc., New England's largest provider of services for veterans and their families, is a mission-oriented, non-profit agency offering a fast-paced, professional work environment for an experienced, creative, and goal-oriented Grant Writer.
Globus Medical IncTechnical Writer Globus Medical IncTechnical WriterMassachusetts, MAThis role bridges engineering, clinical, regulatory, and quality teams to translate complex imaging concepts into user-friendly documentation that supports product development, regulatory submissions, and end-user adoption. We value all employees' talents and support an environment that is inclusive and respectful.\n \nOther Duties:\n \nPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Axcelis Technologies IncNewTechnical Writer Axcelis Technologies IncTechnical WriterBeverly, MA$56,271.60–$103,118.40 / yearAs a Product Documentation Technical Writer, your work will directly support customer success by making critical information clear, accurate, and accessible-helping users install, operate, maintain, and upgrade advanced equipment with confidence. If you enjoy working closely with engineering teams, learning sophisticated systems, and creating documentation that has real-world impact, this role offers the chance to contribute to both innovation and usability in a highly technical industry.
MMSNonclinical Writer MMSNonclinical WriterBoston, MARemoteFull timeRoles and Responsibilities:Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs). Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity.
Kforce Inc.NewTechnical Writer Kforce Inc.Technical WriterActon, MARemote$48–$48Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. A strong background in technical writing is required, along with 1-2 years of experience creating user-facing instructional manuals and working in Adobe Creative Cloud.
Appian CorpFederal Proposal Writer Appian CorpFederal Proposal WriterBoston, MA$50,000–$125,000 / yearGrowth Opportunities: Appian provides a diverse array of growth and development opportunities, including our leadership program tailored for new and aspiring managers, a comprehensive library of specialized department training through Appian University, skills based training, and tuition reimbursement for those aiming to advance their education. You will partner closely with Sales, Solutions, Product, Delivery, and Subject Matter Expert teams to clearly articulate how the Appian Platform addresses complex mission systems programs and federal customer needs.
Wolters Kluwer N.V.Senior Technical Writer - Clinical Decision Support Wolters Kluwer N.V.Senior Technical Writer - Clinical Decision SupportWaltham, MA$60,700–$106,000 / yearAs part of the Wolters Kluwer Pharmacy and Health Technology Solutions team, the Senior Technical Writer role for Medi-Span is responsible for writing, organizing, and publishing comprehensive and easy-to-understand customer-facing technical documentation for a range of embedded drug data and Clinical Decision Support solutions. Note: "Documentation" includes a variety of formats including videos, chatbot, interactive models, and mobile access and could include internal-facing documentation that customer-facing teams need to support customers.
Alliance Technical GroupNewTech Services Writer I Alliance Technical GroupTech Services Writer ISharon, MA$22–$25 / hourThe primary duties of the Technical Services Writer include technical writing of proposals, test plans and reports for source testing projects. Draft reports are. then provided to the project manager or technical services manager for review prior to submittal to the clients.
Actalent IncTechnical Writer Actalent IncTechnical WriterBedford, MA$25–$53 / hourYou will work closely with engineering teams and contract manufacturers to capture complex technical processes, photograph them, and translate them into accessible instructions for end users and production staff. Collaborate with cross-functional teams working on robotics, automated equipment, and complex electromechanical systems to ensure documentation reflects current designs and practices.
Mondelez InternationalR-162831 Full Time Nabisco Merchandiser/Order Writer Mondelez InternationalR-162831 Full Time Nabisco Merchandiser/Order WriterBrockton, Massachusetts$19–$21We're leading the future of snacking with iconic global and local brands such as Oreo, Ritz, LU, Clif Bar and Tate's Bake Shop biscuits and baked snacks, as well as Cadbury Dairy Milk, Milka and Toblerone chocolate. Join our team of Full Time Nabisco Merchandiser/Order Writers and fulfill the merchandising needs of our customers through communication & relationship building, stocking store shelves, and maintaining or changing out displays.
Mondelez InternationalNewR-168491 Full Time Nabisco Merchandiser/Order Writer - Lowell, MA Mondelez InternationalR-168491 Full Time Nabisco Merchandiser/Order Writer - Lowell, MAPeabody, Massachusetts$23.44–$25.44As a Brand Execution Merchant, you’ll bring world-famous snacks like Oreo, Ritz, belVita, Chips Ahoy!, and Triscuit to life in-store – building relationships, stocking shelves, executing displays, and ensuring shoppers always find their favorite snacks right where they expect them. We're leading the future of snacking with iconic global and local brands such as Oreo, Ritz, LU, Clif Bar and Tate's Bake Shop biscuits and baked snacks, as well as Cadbury Dairy Milk, Milka and Toblerone chocolate.
Center for Responsive SchoolsEditor/Writer Center for Responsive SchoolsEditor/WriterTurners Falls, MA$45,992PRIMARY DUTIES & RESPONSIBILITIES INCLUDE: Contributes to the writing, editing, copyediting, background research, and proofing stages of CRS retail publications, including books, articles, Quick Coaching Guides, student books and materials, teaching guides, online content, video, and various other products. The Editor must be able to create and adhere to style sheets and guides, be skilled in writing for different audiences, have a basic understanding of product development in a publishing setting, and be able to work on multiple projects and deadlines with different teams.
HonorVet TechnologiesVigilance Writer HonorVet TechnologiesVigilance WriterActon, MARemote$46.55–$46.55 / hourJob Description: The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations.
HGANewSr Editorial Writer HGASr Editorial WriterBoston, MA$88,000–$105,000 / yearThe ideal candidate is both a strong writer and a disciplined editor-someone who can generate original ideas, collaborate with subject matter experts, and maintain a consistent brand voice across diverse formats. Curiosity, strategic thinking, and audience awareness are essential, as is the ability to translate complex concepts from architecture, engineering, planning, interiors, research, and innovation into engaging, accessible narratives.
SHI International CorpContent Strategist & Writer - Next Gen Infrastructure & AI SHI International CorpContent Strategist & Writer - Next Gen Infrastructure & AIHome Office, MA$80,000–$150,000 / yearThis position blends content strategy, editorial storytelling, and marketing writing, translating complex datacenter, networking, and infrastructure technologies-alongside emerging AI capabilities such as AI-enabled infrastructure, automation, and data platforms- into clear, value-driven narratives that resonate with target audiences. The Content Strategist partners closely with product and solutions marketing, growth marketing, demand generation, creative teams, and subject matter experts to create content that educates buyers, differentiates SHI in the market, and drives measurable growth across the funnel.
InterSystemsNewTechnical Writer InterSystemsTechnical WriterBoston, MA$80,000–$104,000 / yearOur data platforms solve interoperability, speed, and scalability problems for large organizations around the globe to unlock the power of data and allow people to perceive data in imaginative ways. InterSystems is providing a current good faith estimate of the anticipated base salary range for this position depending on a variety of factors including experience, education, skills, and performance.
Victory Capital Holdings IncMarketing Content Writer and Editor Victory Capital Holdings IncMarketing Content Writer and Editorboston, MA$72,250–$85,000 / yearTarget Compensation:The target base salary range for this position is $72,250 - $ 85,000.Salaries are determined based on internal equity, internal salary ranges, market data/ranges, applicant's skills and prior relevant experience, certain degrees, and certifications. Marketing Content Writer and EditorSan Antonio, TX | Boston, MAAbout Victory Capital:Victory Capital (NASDAQ: VCTR) is a diversified global asset management firm.
Mondelez International IncNewFull Time Nabisco Merchandiser/Order Writer Mondelez International IncFull Time Nabisco Merchandiser/Order WriterBrockton, MA$23.44–$25.44 / hourWe have corporate offices, sales, manufacturing and distribution locations throughout the U.S. to ensure our iconic brands-including Oreo and Chips Ahoy! cookies, Ritz, Wheat Thins and Triscuit crackers, and Swedish Fish and Sour Patch Kids confectionery products -are close at hand for our consumers across the country. Join our team of Full Time Nabisco Merchandiser/Order Writers and fulfill the merchandising needs of our customers through communication & relationship building, stocking store shelves, and maintaining or changing out displays.
iHeartMedia IncP/T News Writer/Producer - Weekend & Holiday Mornings iHeartMedia IncP/T News Writer/Producer - Weekend & Holiday MorningsMedford, MA$17.66–$22.08 / hourPodcasting, the fastest-growing new media, today has more monthly users than streaming music services or Netflix; iHeart is the home of many of the country's most popular and trusted on-air personalities and podcast influencers, who build important connections with hundreds of communities across America; We create and produce some of the most popular and well-known branded live music events in America, including the iHeartRadio Music Festival, the iHeartRadio Music Awards, the iHeartCountry Festival, iHeartRadio Fiesta Latina and the iHeartRadio Jingle Ball Tour; iHeartRadio is the #1 streaming radio digital service in America; Our social media footprint is 7 times larger than the next largest audio service; and. The audio revolution is here - and iHeart is leading it! iHeartMedia, the number one audio company in America, reaches 90% of Americans every month -- a monthly audience that's twice the size of any other audio company - almost three times the size of the largest TV network - and almost 4 times the size of the largest ad-supported music streaming service.
Kura OncologyNewSenior Director, Medical & Regulatory Writing Kura OncologySenior Director, Medical & Regulatory WritingBoston, MA$265,000–$306,000 / yearKura developed and is commercializing KOMZIFTI (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.
BostonGene CorpDirector, Medical Communications BostonGene CorpDirector, Medical CommunicationsMACross-Functional Collaboration: Supports the development of medical communications for external audiences, including press releases, white papers, and materials for pharma and biotech clients, investors, regulatory agencies, and healthcare providers. Strategic Communication Development: Develop and implement comprehensive communication strategies that align with the company's business goals, including client interactions, congress strategy, publication strategic planning and regulatory submissions.
EBSCOClinical/Medical Editor II EBSCOClinical/Medical Editor IIIpswich, Massachusetts$68,070–$97,240 / yearYour Opportunity: The Medical-Surgical/Home Health Clinical Editor will be responsible for supporting the Section Editors in overseeing the development of high-quality content within specific content domain(s), applying both clinical knowledge/experience and the principles of evidence-based practice. The candidate must have the ability to analyze and critically appraise medical, nursing and allied health research and literature, write clinical topics and edit work produced by clinical editorial team.
Takeda Pharmaceutical Co LtdAssociate Director, Scientific Communications Lead, Solid Tumors, Global Medical Affairs Oncology Takeda Pharmaceutical Co LtdAssociate Director, Scientific Communications Lead, Solid Tumors, Global Medical Affairs OncologyCambridge, MA$169,400–$266,200 / yearThe Associate Director, Scientific Communications Lead, develops and implements strategic publications and scientific communications plans in coordination with relevant cross-functional teams (including members of medical affairs, clinical development, and outcomes research; global, regional, or local); leads the publications planning team; manages the development of scientific publications for external audiences and scientific communications materials such as slide decks, NCCN or pathway submissions, animations, and digital amplification of data; manages vendors, freelancers, and available contractors, writers, and editors in the execution of publication and scientific communications tactics; and manages annual budget planning for each assigned program(s). As a subject matter expert on scientific publications best practices and the development of scientific communications strategy and deliverables, the Associate Director, Scientific Communications Lead, Solid Tumors proactively defines and drives the publication and scientific communication strategic plan and deliverables for the assigned oncology assets based on medical strategies, transparency requirements, and data availability.
Takeda Pharmaceutical Co LtdSenior Manager, Scientific Communications, Solid Tumor, Global Medical Affairs Oncology Takeda Pharmaceutical Co LtdSenior Manager, Scientific Communications, Solid Tumor, Global Medical Affairs OncologyCambridge, MA$151,100–$237,490 / yearThe Senior Manager, Scientific Communications develops and implements strategic publications and scientific communications plans in coordination with relevant cross-functional teams (including members of medical affairs, clinical development, and outcomes research; global, regional, or local); leads the publications planning team; manages the development of scientific publications for external audiences and scientific communications materials such as slide decks, NCCN or pathway submissions, animations, and digital amplification of data; manages vendors, freelancers, and available contractors, writers, and editors in the execution of publication and scientific communications tactics; and manages annual budget planning for each assigned program(s). As a subject matter expert on scientific publications best practices and the development of scientific communications strategy and deliverables, the Senior Manager, Scientific Communications proactively defines and drives the publication and scientific communication strategic plan and deliverables for the assigned oncology assets based on medical strategies, transparency requirements, and data availability.
Vertex Pharmaceuticals IncAssociate Director Medical Writing (Hybrid) Vertex Pharmaceuticals IncAssociate Director Medical Writing (Hybrid)Boston, MARemote$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.
ImCheck Therapeutics SASNewDocument Specialist ImCheck Therapeutics SASDocument SpecialistCambridge, MA$91,500–$134,200 / yearExperience as a clinical/regulatory/safety Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts. Working with minimal guidance, the incumbent will take accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions.
Ipsen SANewDocument Specialist Ipsen SADocument SpecialistCambridge, MA$91,500–$134,200 / yearExperience as a clinical/regulatory/safety Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts. Working with minimal guidance, the incumbent will take accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions.
BioNTechNewDepartment Lead Scientific Communications BioNTechDepartment Lead Scientific CommunicationsCambridge, MALead the scientific communication team supporting Phase II/III and prelaunch/launch activities, including: Global publication and congress strategy for pivotal and late-stage studies Scientific platforms and key messaging for each asset and indication Data communication materials for internal and external stakeholders (e.g., scientific decks, FAQs, narrative documents). The ideal candidate has substantial experience in large, international pharmaceutical companies (and ideally some biotech exposure), with a strong track record of leading cross functional scientific communications, shaping global publication strategies, and supporting product launches.
MMSSenior 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.
MMSPrincipal Biostatistician - Remote MMSPrincipal Biostatistician - RemoteBoston, MARemoteFull timeProduce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction. Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors.
Celldex Therapeutics IncSr. Clinical Scientist/Associate Director, Clinical Science Celldex Therapeutics IncSr. Clinical Scientist/Associate Director, Clinical ScienceNeedham, MA$133,579–$199,501 / yearAuthor (and/or work with external medical writers to develop) clinical documents including but not limited to clinical protocols/amendments, briefing documents, IND annual reports, Investigators Brochures, clinical study reports, scientific presentations including abstracts, posters and manuscripts. Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborate with statisticians to produce statistical analysis plans and data displays; provide input to CRF design and data management processes; perform periodic review of clinical data).
Celldex Therapeutics IncDirector/Senior Director, Clinical Science Celldex Therapeutics IncDirector/Senior Director, Clinical ScienceNeedham, MA$176,659–$263,841 / yearAuthor (and/or work with medical writer to develop) clinical documents including but not limited to: clinical protocols, briefing documents, IND annual reports, Investigators Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts, posters and scientific presentations. Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborate with statisticians to produce statistical analysis plans and data displays; provide input to CRF design and data management processes; perform periodic review of clinical data).
ImCheck Therapeutics SASClinical 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 .Ensure complete data tracking by the SP with the Data Collection Template (DCT).Check the data received from the SP.Ensure the information is properly recorded in the Data Transparency system (COLLECT), implement corrective actions where needed. 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.
Ipsen SAClinical 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.
Northeastern UniversityPostdoctoral 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.
US Tech Solutions, Inc.Clinical Reviewer Outpatient Registered Nurse # 26-10731 US Tech Solutions, Inc.Clinical Reviewer Outpatient Registered Nurse # 26-10731Canton, MA$50–$50 / hourKey Responsibilities/Duties – what you will be doing:Provides all aspects of clinical decision making and support needed to perform utilization management, medical necessity determinations and benefit determinations using applicable coverage documents, purchased clinical guidelines or Medical Necessity Guidelines for clinically complex services / coverage requests in a consistent manner and within established, product specific time frames. Interfaces between Precertification staff and providers when issues arise regarding policy interpretation, potential access availability or other quality assurance issues to ensure that members receive coverage decisions timely within all accrediting and regulatory guidelines.
CobaltNewField Chief Information Security Officer CobaltField Chief Information Security OfficerBoston, MARemote$157,800–$197,250 / yearAccepting just 5% of applicants, the Cobalt Core boasts over 400 closely vetted and highly skilled testers who jointly conduct thousands of tests each year and are at the forefront of identifying and helping remediate risk across a dynamically changing attack surface. You are a market-facing executive—a peer to our customers' CISOs, a strategic and practical hand-on advisor to our sales teams, and a public face of Cobalt's vision for the future of human-led, AI-driven pentesting.