Director, Medical Writing — Lead Clinical & Regulatory Docs
Meridabio
Merida Biosciences is seeking a Director, Medical Writing to lead development of clinical and regulatory documents supporting our advancing pipeline in a fast-paced biotech environment. Reporting to the Senior Director, Regulatory Affairs & Medical Writing, you will author, review, and manage a broad range of documents, establish standards, and collaborate across Regulatory, Clinical Development, Biostatistics, and Quality teams to ensure scientifically robust messaging. #J-18808-Ljbffr Meridabio
$220k - $260k
Position Summary We are seeking an experienced medical writer with deep expertise in clinical and regulatory documents and demonstrated experience using AI-enabled... ...combines strong scientific and regulatory writing judgment with practical experience using generative...MedicalRegulatory$200k - $270k
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Verastem Oncology in Boston is seeking an experienced medical writer to produce high-quality clinical documentation. The ideal candidate will possess strong expertise in clinical and regulatory writing and utilize AI tools effectively to enhance document quality and efficiency...MedicalRegulatory- Scorpion Therapeutics in Boston, Massachusetts seeks a Medical Writing Science Manager to prepare clinical and regulatory documents. This role involves authoring, reviewing, and ensuring consistency in documentation while collaborating with cross-functional teams. The...MedicalRegulatory
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Medical Writing Lead, Global Clinical Operations, Orion Pharma Cambridge, United Kingdom and 3 more (Hybrid) Job Description Orion Pharma is a purpose... ...across all phases of drug development and global regulatory submissions, ensuring quality and compliance through leadership...MedicalRegulatoryWorldwide- Ipsen Biopharmaceuticals Inc. is looking for a Senior Medical Writer in Cambridge, US. This role involves producing high-quality clinical documentation and managing the preparation of regulatory documents for submissions to global health authorities. The ideal applicant...MedicalRegulatoryFlexible hours
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$211.91k - $256.79k
Associate Director, Global Clinical Science Reports through the Clinical... ...as Clinical Trial Lead for one or more... ...in collaboration with Medical Monitor and Clinical... ...guidance; including writing, reviewing, adjudication... ...clinical portions of Regulatory Documents (e.g., IB,...MedicalRegulatoryHourly payFull timeTemporary workSummer workFlexible hoursShift work$161.7k - $202.2k
...Position Summary The Associate Director, Clinical Scientist is a highly... ...The role works closely with Medical Directors to support medical... ...Sciences, Medical Affairs, and Regulatory Affairs to translate clinical... ...communication and technical writing skills, with demonstrated experience...MedicalRegulatory$169.68k - $254.52k
...Translational Imaging Lead The Director, Translation Imaging Lead independently... ...techniques from early clinical through registration phases... ...collaborations; Ensure regulatory compliance of imaging... ...Required qualifications: Medical Doctor (MD or MD/PhD) or imaging...MedicalRegulatory$160.6k - $240.8k
General Summary The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced... ...compliance with GCP regulatory requirements and guidance... ..., both verbally and in writing, to internal and external... ...trials, understand medical terminology, standards...MedicalRegulatoryWork experience placementSummer workWork at office- ...Responsibilities Provide strategic medical guidance for... ...for Translational Clinical Oncology (TCO) aspects... ...subsequent registration trials. Lead Biomedical Research... ...experts, investigators, and regulatory authorities; act as... ...for global studies; write/review abstracts/manuscripts...MedicalRegulatoryWorldwide
- ...looking for a Growth Lead, Partnerships &... ...decks, positioning docs, talking points,... ...partners: audience, clinical credibility,... ...publishes without medical sign‑off Manage production... ...and outreach. You write within the brand... ...understand the regulatory environment, patient...MedicalRegulatoryFixed term contract
$248.5k
.... CPL: Provides strategic medical guidance and leads the development of experimental... ...at the PE / DC Creates clinical development strategies for... ...experts, investigators, and regulatory authorities in oncology,... ...those groups and authorities Writes and reviews abstracts/...MedicalRegulatoryWork at officeLocal area$128.9k - $226.05k
...Lead Technical Product Manager - UpToDate Growth Locations... ...Kluwer, we combine deep clinical expertise with responsible AI... ...required for clinical, privacy, and regulatory environments. User Insight... ...but not limited to: Medical, Dental, & Vision Plans, 401(...MedicalRegulatoryWork at office$144.9k - $163.8k
...The Director, Infection Prevention & Control... ...Senior Director, Clinical Safety and in collaboration... ...other Harvard Medical School-affiliated... ...control and regulatory compliance. Oversees... ...regulatory bodies. Leads all infection... ...programs. Excellent writing skills for...MedicalRegulatoryWork at office2 days per week3 days per week- ...the U.S. and are exploring regulatory pathways for Europe and... ...treatment resistance. With clinical trials underway, we have an... ...are seeking a Scientific Director, Medical Affairs to lead various initiatives within... ...ongoing and planned studies Write and edit publications as...MedicalRegulatoryFreelanceFlexible hours
$176.1k - $287.3k
...are seeking an Associate Director to join our Clinical Scientist, Internal Medicine... ...collaborates closely with Medical Director(s) (MDs) to... ...supports the development of regulatory documents; performs quality... ...demonstrates solid medical writing skills ~ Experience in all...MedicalRegulatoryWorldwide$185.37k - $308.95k
Associate Director, Medical Review Lead, MSRM Who we are At Agios, we are fueled by connections to transform... ..., ensuring medical accuracy, regulatory compliance, and high-quality safety... ...management activities, and development of clinical and regulatory documents....MedicalRegulatoryTemporary workRemote workWork from homeFlexible hours3 days per week$286.9k
...Principal Scientist (Senior Medical Director) Translational... ...closely with scientific, regulatory, statistical, and... ...for assessment in large clinical populations. We are seeking... ...biomarker plans for Lead Optimization programs,... ...Strong interpersonal, writing and presentation...MedicalRegulatoryFor contractorsWork at officeRemote workWorldwideMonday to FridayMonday to ThursdayShift work3 days per week$222k - $258k
...Bicara Therapeutics is seeking a proactive and detail-oriented Director, Medical Writing to lead the development of complex, high-quality scientific documents that support our clinical development and regulatory submissions. Reporting to the VP, Regulatory Affairs, the...MedicalRegulatoryLocal areaFlexible hours3 days per week- ...today and address the medical challenges of tomorrow... ...experience to analyze clinical, survey and claims databases... ...specifications and directors to the HEOR... ...HEOR. Contribute to the writing and publishing of scientific... .... Monitor scientific, regulatory and reimbursement/access...MedicalRegulatoryLocal area
$176.1k - $287.3k
...an exciting opportunity to lead projects across diverse therapeutic... ...areas. As the Associate Director, Clinical Diagnostics (CDx), you will... ..., clinical development, regulatory, commercial, and external IVD... ...Partner with commercial and medical affairs to shape CDx launch...MedicalRegulatory$225k - $275k
...of antibody-driven diseases. Merida Biosciences is seeking an experienced and strategic Director, Medical Writing to lead the development of high-quality clinical and regulatory documents that support our advancing pipeline. Reporting to the Senior Director, Regulatory...MedicalRegulatoryLocal area$169.4k - $266.2k
...part of the Global Medical Affairs Oncology... ...Communications Group Lead, Solid Tumors. As... ..., the Associate Director, Scientific Communications... ...medical affairs, clinical development, and... .... Manage medical writing agency, including... .... Compliance and Regulatory: Excellent...MedicalRegulatoryMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work- Takeda is seeking an Associate Medical Director in Cambridge, MA to lead strategy for clinical studies within the Neuroscience Therapeutic Area. This role involves... ...with global teams and decision-making impacting regulatory approvals. The ideal candidate holds an MD or...MedicalRegulatory
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A biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages. The successful candidate... ...of medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to...MedicalRegulatory$204.4k - $379.6k
...Hybrid Internal Title: Director Location:... ...making/progression by leading and empowering an interdisciplinary... .... If, because of a medical condition or... ..., Bioinformatics, Clinical Data Management,... ...Solving Skills, Regulatory Compliance, Report Writing, Strategic Thinking...MedicalRegulatoryFor contractors$263k - $328k
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...patients, and who lead with the desire to... ...ideas. As an MSAT Director, you will report to... ...CMC sections of regulatory documents (IND module... ..., technical writing and verbal communication... ...support phase 1 clinical trials including cryopreservation... ...C infection, medical condition (cancer...MedicalRegulatoryWork experience placement
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