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
- ...Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the development... ...scientific judgment and regulatory writing expertise, plus the ability to lead#J-18808-LjbffrMedicalRegulatory
$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base pay... ...Unit (OBU) and Global Medical Marketed Products Development... ...are in place. Leads the clinical pre-... ...confirmed violations to regulatory authorities. Lead... ...problems. Strong technical writing skills; able to write...MedicalRegulatoryTemporary workFor contractorsWork at officeImmediate startNight shift2 days per week- Zenith LifeScience in the United States is seeking a Clinical Regulatory Writing Associate Director to lead complex regulatory writing across drug development... ...compliant submissions. The role requires extensive medical writing experience in pharma or CROs, strong...MedicalRegulatory
- ...Associate Director, Clinical Scientist How you'll make an impact... ...Serve as the study lead Clinical Scientist in immunology... ...and alignment with regulatory standards. Conduct clinical and medical data reviews, including... ...abilities and excellent medical writing skills....MedicalRegulatory
- Synterex, Inc. is seeking a senior medical writer to lead planning and preparation of high-quality regulatory documents within our medical writing team. You will partner across Clinical Development, Regulatory, and Program Management to deliver protocols, study reports...MedicalRegulatoryRemote job
$150k - $200k
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- The Clinical Regulatory Writing team provides expert communications leadership to... ...vision is to be an industry leading organization driving strategic... ...Writing Associate Director is expected to: Independently... ...strong partnership with vendor medical writers to ensure delivery...MedicalRegulatory
$160.6k - $240.8k
...DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for... ...drive compliance with regulatory requirements to ensure... ...both verbally and in writing to internal and external... ...clinical trials, understand medical terminology, standards...MedicalRegulatoryFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$133.04k - $199.56k
...Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Boston, MA OR... ...Director in Clinical Regulatory Writing, you'll play a pivotal... ...acting as a submission lead. Lead internal/... ...and partner with vendor medical writers to ensure timely...MedicalRegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week$176.1k - $287.3k
...are seeking an Associate Director to join our Clinical Scientist, Internal Medicine... ...collaborate closely with Medical Director(s) to provide scientific... ...the development of regulatory documents; performs quality... ..., and solid medical writing skills Experience in all...MedicalRegulatoryWorldwide$200k
...Responsibilities The Lead Clinical Laboratory Scientist position... ...certification, in writing, that your continued... ...Program Manager, Regional Director, Laboratory Director,... ...current laboratory regulatory requirements. The work... ...departments/divisions of the medical center for the...MedicalRegulatoryPermanent employmentFull timeWork experience placementSeasonal workWork at officeRemote workTrial periodRelocation packageMonday to FridayFlexible hoursWeekend work$200k
...Duties Help The Lead Clinical Laboratory Scientist... ...receive certification, in writing, that your continued... ...Manager, Regional Director, Laboratory Director,... ...with current laboratory regulatory requirements. The work... ...departments/divisions of the medical center for the...MedicalRegulatoryPermanent employmentFull timePart timeWork experience placementSeasonal workWork at officeRemote workTrial periodRelocation packageMonday to FridayFlexible hoursWeekend work$177k - $259.6k
...Title: Director, Medical Writing Lead, Rare Disease Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized... ...strategies within the assigned Therapy Area that drive clinical study and regulatory document authoring to the highest quality and...MedicalRegulatoryFull timeTemporary workLocal areaRemote workFlexible hours$223k - $236k
...highly motivated and experienced Director of Clinical and Technical Writing to join our dynamic team. This... ...documentation across Clinical, Regulatory, Technical, and Medical Affairs functions. The ideal... ...and organizational priorities.Lead the Writing Process End-to-End:...MedicalRegulatoryFor contractorsWork at officeRemote work$161.7k - $202.2k
Zenas is a clinical-stage global biopharmaceutical... ..., Zenas’ lead product candidate,... ...Summary:The Associate Director, Clinical Scientist... ...closely with Medical Directors to support... ...Medical Affairs, and Regulatory Affairs to... ...communication and technical writing skills, with...MedicalRegulatory$100k - $186.3k
...Scientist/Associate Director to support and help lead operations of our state... ...other Harvard Medical School-affiliated hospitals... ...reproducibility and clinical relevance. ~... ...Contribute to grant writing, progress reports, and... ...Ensure adherence to regulatory, ethical, and...MedicalRegulatoryFull time$160.6k - $240.8k
...Summary The Associate Director of GCP Operational... ...activities of clinical trial operations and... ...with GCP regulatory requirements and guidance... ...improvements. Develop and lead inspection... ...verbally and in writing to internal and external... ...; understands medical terminology,...MedicalRegulatorySummer workWork at officeRemote workFlexible hours2 days per week$154.4k - $242.55k
...and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business... ...internal stakeholders, including Clinical, Pharmacovigilance, Legal,... ...strategically interprets scientific, medical, and regulatory data and information...MedicalRegulatoryMinimum wageTemporary workLocal area- ...Inc. is seeking an experienced Clinical Scientist, Associate Director to support oncology development... ...requires strong data interpretation, medical writing, and regulatory submission capabilities, with... ...business needs require. You will lead clinical data reviews, support...MedicalRegulatoryRemote job
$310.9k
...DescriptionThe Executive Director (Distinguished... ...Team (PDT) lead has primary responsibility... ...and directing of clinical research... ...monitoring, analysis, regulatory reporting, publication... ...verbally, in writing, and during presentationsPreferred... ...benefits include medical, dental, vision...MedicalRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$169.4k - $266.2k
...part of the Global Medical Affairs Oncology... ...will report to the Director, Global Scientific... ...Communications Group Lead. This is a hybrid... ...medical affairs, clinical development, and... ...needsManage medical writing agency, including... ...analysesCompliance and Regulatory: Excellent...MedicalRegulatoryMinimum wageTemporary workFor contractorsFreelanceLocal areaRemote work$210k - $260k
...committed to establishing the leading, fully integrated platform... ...the Beam portfolio. The Director of Pharmacovigilance will... ...but not limited to Clinical Operations, Biometrics, Data... ...Development, Clinical Science, Regulatory Affairs, Medical Writing, Nonclinical, and Quality....MedicalRegulatoryFull time3 days per week1 day per week$167k - $286k
...programs and includes clinical programs for Duchenne muscular... ...Possible”, we are leading the charge toward a... ...disease.Description: The Director/Associate Director, Platform and Pipeline Medical Affairs Lead will be responsible... ...developmentExperience writing and publishing clear,...MedicalContract workTemporary workSummer workWork at officeLocal area$210k - $300k
...OverviewRhythm is seeking a Senior Director, Biostatistics to join... ...supporting important clinical development programs.... ...will serve as the lead statistician for... ...across clinical, regulatory, safety, data management, programming, and medical writing/publications teams to...MedicalRegulatoryInterim roleWork at officeFlexible hoursShift work$181k - $194k
...Clinical Scientist, Associate Director Remote Role: Flexible schedule with... ...Phase 3 results for our lead candidate, it’s an... ...clinical trial execution, medical monitoring, data interpretation, regulatory documentation, and... ...Management, Medical Writing, and...MedicalRegulatoryFull timeRemote workVisa sponsorshipWork visaFlexible hours$161.5k - $218.5k
...6-08-16Overview The Associate Director, Medical Education Marketing, US Congress and TLL Asset Lead will lead national strategy and... ...teams to support internal clinical expertise and reinforce key messaging... ...educational initiatives meet regulatory standards and strategic...MedicalRegulatoryFull timeTemporary workLocal area$166.5k - $264k
...Job Description Title: Director/Sr Director, Focused... ...with academic, clinical, and regulatory stakeholders, and mentoring... ...permeabilization; lead cross-functional and... ...research, technical writing, and translational planningProven... ...; eligibility for medical, dental, vision and...MedicalRegulatoryFlexible hours- Define and govern the Vaccines Medical AI strategy and roadmap... ...success metrics for AI investments Lead design, piloting, and scaled... ...evolving U.S. and global regulatory, legal, privacy, and ethical... ...medical or scientific strategy, clinical development, or a related scientific...MedicalRegulatoryPermanent employment
$242.25k - $403.75k
Job Title: Senior Director, Portfolio Integration Lead - Hematology Overview Cancer is... ...alignment. Drive and support clinical trial innovation based on... ...in R&D, Global Medical Affairs, and Global Product... ...authority interactions, regulatory submissions and key development...MedicalRegulatoryLocal areaRemote workWork from home- ...DescriptionGeneral Summary:The Associate Director, Medical Writing Science manages the overall... ...for document development for regulatory filings and coordinates the clinical sections of more complex... ...also include inclusive market-leading benefits to meet our employees...MedicalRegulatoryFull timeWork experience placementSummer workWork at officeRemote workRelocation packageFlexible hours2 days per week3 days per week
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