Medical Writer Disc Medicine IncMedical WriterMassachusetts, MA$117,000–$143,000 / yearCommunicate and coordinate with line-function team members to gather, organize, and compile information towards the development and planning of writing scientific, clinical, and regulatory documents; communicate deliverables needed, writing process and timelines, and hold team members accountable to agreed-upon dates for deliverables. RESPONSIBILITIES: Partner and collaborate with clinical and regulatory team members in the preparation of clinical protocols and regulatory documents; participate in study results interpretations and manage the document review/approval process to capture comments and resolve conflicts, including running round-table meetings.
Sr. Medical Writer Integrated Resources, IncSr. Medical WriterMansfield, MassachusettsFull timeThis position will meet and communicate regularly with Clinical Affairs, PACE, R&D, marketing, Sales, KOL's and others as necessary to build and collaborateQualificationsSpecial Notes:100% remote work is possible, on site is preferredPHD with 5+ years of experience or Nurses with 10+ years of experience is requiredThe Medical Writer has to review the post market surveillance data, has to create a demonstration of safety reportsExtensive experience with Clinical Evaluation Report is required, person has to be able analyze complex scientific informationPost Marker Surveillance experience is requiredGood understanding of risk management and hands on experience with risk management documentation is requiredAdditional InformationKind Regards,Sabanaaz ShaikhClinical RecruiterIntegrated Resources, Inc. abstracts, manuscripts, presentationsRequires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical dataIndependently, critically writes and edits scientifically complex documents for substantial intellectual contentReviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goalsExpert knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practicesAbility to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiencesNon-essential functions:1.
Senior Regulatory Medical Writer Ionis Pharmaceuticals IncSenior Regulatory Medical WriterBoston, MARemote$113,000–$142,426 / yearThis role includes responsibilities throughout the lifecycle of a document including working cross-functionally to interpret source information (including leading data interpretation meetings), leading key messaging meetings, writing content following US and international regulations (including Marketing Application Module 2 summary documents), conducting quality control (QC) reviews, resolving Quality Assurance (QA) audit findings, and working with Regulatory Operations for publishing and submission. Experience writing, as lead and/or contributor, important regulatory and clinical documents such as clinical study reports (all sections including safety narratives), Investigator's Brochures, clinical study protocols, drug marketing application summary documents, Investigational New Drug applications, clinical sections of New Drug Applications, and other regulatory documents (e.g., Briefing Documents) for submission.
Medical Writer - I Integrated Resources, IncMedical Writer - IRaynham, MassachusettsContractormedical writing, regulatory affairs, clinical research, engineering)BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experienceKnowledge/RequirementsExcellent English language skills, especially writing and proofreading. Job DescriptionOverview:The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences.
Medical Writer Integrated Resources, IncMedical WriterCambridge, MassachusettsContractorIRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ.We have been honored by the following:Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009Top 500 Privately-Held Business in the USTop 500 Diversity Owned Business in the USTop 100 Subcontinent Asian American Business in the USInc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010Honored as an Emerging Business of the Year finalist by NJ BIZ in 2009Job DescriptionIn this role, incumbent will be expected to provide Medical Writing leadership for clinical development, registrational, and LCM programs.
Senior Regulatory Medical Writer, Client-embedded, FSP Thermo Fisher Scientific IncSenior Regulatory Medical Writer, Client-embedded, FSPFramingham, MA$110,000–$125,000 / yearAs one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. The successful candidate will have a proven track record in authoring clinical regulatory documents; ideally they will also bring the versatility to author and support preclinical regulatory documents as part of a broader regulatory writing portfolio.
Medical Writer - India (56829) Praxis Precision MedicinesMedical Writer - India (56829)Boston, MACollaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications. This requires the knowledge and expertise to collaboratively author required documents with support and input from the Associate Director, Medical Writing while also helping other teams follow medical writing processes and style requirements.
Medical Writer Perceptive Informatics LLCMedical WriterMA$65,305–$93,000 / yearThe Medical Writer will create, research, edit and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations and supplementary imaging reports, using available central content and templates. Serve as the medical writing representative on assigned project teams communicate content requirements, Coordinate and conduct interdepartmental team reviews of draft and final documents, Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Calyx and/or client guidelines/SOPs.
Senior Medical Writer Centessa Pharmaceuticals PlcSenior Medical WriterBoston, MA$150,000–$190,000 / yearOversee document preparation from start to finish, including kick-off activities and planning, drafting, managing review cycles, incorporating feedback and revisions, addressing quality control and quality assurance findings, and providing a final version within document timelines. Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines.
Senior Medical Writer (Remote) MMSSenior Medical Writer (Remote)Boston, MARemoteFull timeWrite and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
Senior Medical Writer Centessa Pharmaceuticals, LLCSenior Medical WriterBoston, MA$150,000–$180,000 / yearOversee document preparation from start to finish, including kick-off activities and planning, drafting, managing review cycles, incorporating feedback and revisions, addressing quality control and quality assurance findings, and providing a final version within document timelines. Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.
Principal Medical Writer- MedPubs Focus VeristatPrincipal Medical Writer- MedPubs FocusMassachusettsFinal salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. Proficient in MS Office Suite (advanced MS Word, PowerPoint and Excel); Adobe Acrobat for developing and editing poster slides, pdf poster layouts and slide sets.
NewAssociate Director-Medical Writer Eli Lilly and CoAssociate Director-Medical WriterBoston, MA$127,500–$187,000 / yearOur current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Collaborate effectively with cross-functional teams, including clinical development, regulatory affairs, biostatistics, medical affairs, nonclinical, and legal, to gather necessary information and ensure scientific accuracy and consistency across documents.
Principal Medical Writer-nonclinical focus VeristatPrincipal Medical Writer-nonclinical focusMassachusettsPossesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
Senior Medical Writer, Promotional Review Thermo Fisher Scientific IncSenior Medical Writer, Promotional ReviewWaltham, MA$130,000–$150,000 / yearJob Description The Senior Medical Writer - Promotional Review, provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise and may provide assistance to the program manager. Responsible for training and development of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, assisting subordinates with difficult inquiries or problems, interpreting and ensuring consistent application of organizational policies, and development and implementation of unit policies and procedures.
Senior Medical Writer- Clinical Focus VeristatSenior Medical Writer- Clinical FocusMassachusettsFinal salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance.
Software Medical Writer Analog Devices IncSoftware Medical WriterWilmington, MA$110,385–$151,808 / yearFor positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world.
Scientific/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.
Medical Writer (Remote, US) Getinge GroupMedical Writer (Remote, US)Boston, MARemoteStrong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, relevant MDCG guidance, ISO 14155, ICH guidance including E3 CSR, E6 (R3) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO14971). Performs comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required.
Associate Director, Medical Writer MannKind CorpAssociate Director, Medical WriterBedford, MARemoteMannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. Oversee the development and finalization of high-quality, scientifically accurate, ICH-compliant documents, including clinical study protocols and reports, Investigator Brochures, Periodic Safety Updates, patient narratives, and manuscripts for peer-reviewed publications.