Senior Medical Writer, Regulatory & Clinical Documentation
PepGen
A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should have a minimum Bachelor's degree, ideally a PhD, with at least 5 years of experience in regulatory medical writing. The position is based in Boston, offering a dynamic team environment focused on innovative therapy development. #J-18808-Ljbffr
$134.75k - $162.89k
...PROMETRIKA is a full-service clinical research organization... ..., biostatistics, medical writing, and... ...RESPONSIBILITIES The Senior Medical Writer position requires writing... ...analyses for submission to regulatory agencies or sponsor... ...reports, and other documents, as appropriate...SeniorRegulatoryFor contractorsWork experience placement- ...pharmaceutical, biotech, and medical device industries with a... ...to complex trial data and regulatory submission challenges.... ...supervision, the Medical Writer will critically evaluate,... ...of bias Write and edit clinical development documents, including but not limited...SeniorRegulatoryRemote workWorldwide
- ...highly experienced clinical development professionals... ...specializing in medical writing, submission... ...and fully compliant documentation, from early drug development... ...writing team. The senior medical writer will partner cross-... ..., Biostatistics, Regulatory, and Program...SeniorRegulatoryLocal areaRemote work
$150k - $180k
...improving productivity while maintaining minimal centralized infrastructure. Description of Role The Senior Medical Writer will author and manage clinical regulatory documents in support of the company’s clinical development program, reporting to the Director of Medical...SeniorRegulatoryFull time$119.7k - $222.3k
...strategies to transform clinical pharmacology support... ...and interactions with regulatory agencies, as appropriateProactively... ...authoring regulatory documents.This role reports to a... ...to be considered for Senior Principal Scientist.... .... If, because of a medical condition or...SeniorRegulatoryFull time$230k - $281k
...intend to change that. We are a clinical‑stage biopharmaceutical... ...Position Summary Remix is seeking a Senior Director, Clinical Operations... ...the development of clinical documents: protocols, IND submissions,... ...study reports. Partner with Regulatory Affairs and Biostatistics for...SeniorRegulatory$274.4k - $411.6k
...Boston, Massachusetts.Summary The Senior Director, Clinical Development will provide medical and scientific leadership for... ..., and other key clinical documents in compliance with project plans... ...advancementLead clinical contributions to regulatory submissions, including INDs,...SeniorRegulatory$130k - $190k
...motivated and experienced Clinical Data Management professional... ...portfolio.Reporting to the Senior Director of Data Management... ..., Statistical Programming, Medical, Regulatory, and external partners to support... ...and other study-level documentation.Ensure appropriate...SeniorRegulatoryFull timeInterim role- ...Responsibilities The Contract Sr. Clinical Scientist will ideally be... ...with drug development and regulatory requirements and will deploy... ...literature. *Collaborates with medical writing to author clinically... ...amendments *Authors and/or reviews documents related to trials, such as...SeniorRegulatoryContract work
$235k - $330k
Who we are:Kymera is a clinical-stage biotechnology company pioneering... ...you’ll make an impact:The Senior Director, Clinical Operations... ...operational execution through regulatory approval. This person... ...and review of clinical study documents including the Investigator Brochure...SeniorRegulatoryLocal area$152.4k - $190.5k
...website: The Importance of the Role The Senior Clinical Operations Lead, Clinical Operations... ...consults on reports and clinical trial documents such as informed consent, clinical... ...Investigator Brochure, yearly updates to the regulatory authorities and status updates•...SeniorRegulatoryFull timeLocal area$120k - $145k
Senior Clinical Research Associate - Remote with 50% travel Full?Time... ...source data, and review study documentation to support timely and... ...staff on study procedures, regulatory expectations, and GCP compliance... ...working with academic medical centers and sites with varying...SeniorRegulatoryPermanent employmentFull timeInterim roleWork at officeRemote work$145k - $170k
...type 1, progressing into clinical trials, the company... ...on.About the Role: The Senior Clinical Trial Manager... ...), and other clinical documents to ensure seamless... ...internal and external medical experts to optimize and... ...Experience in ethics and regulatory dossier submissions (e...SeniorRegulatoryContract work- ...happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to... ..., filing and reconciliation according to regulatory guidance and internal SOPs.Participates and ensures appropriate documentation of clinical team meetings, including...SeniorRegulatoryLong term contractContract workRemote work
$110k - $120k
Olema Oncology is a clinical-stage biopharmaceutical company committed... ...beyond. About the Role >>> Senior Clinical Trial Associate... ...contributing to study documentation such as informed consent forms... ...Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines...SeniorRegulatoryFull timeContract workWork at officeFlexible hours$137.8k - $206.8k
...DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides... ..., informed consent documents, and other key study documentation... ...clinical programs.Support regulatory agency inspections at... ...growth and aspirations. From medical, dental and vision benefits...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week$117k - $184.2k
Job DescriptionThe Early Clinical Scientist (ECS) coordinates the design... ...of GCP, ICH guidelines and regulatory requirements for clinical... ...Application/Common Technical Document (WMA/CTD) subsections, and regulatory... ...site training/monitoring; medical and regulatory...SeniorRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$236.25k - $393.75k
Job Title: Senior Clinical Research DirectorLocation: Cambridge, MA, Morristown... ...(e.g harmonizing study documents, ES, protocols, etc). As... ...necessary the CRD role:Provide medical expertise to the clinical... ...Global Project Head, The PV Rep, Regulatory and other key functional...SeniorRegulatoryFull time- ...Senior Clinical Project Manager Join Us and Drive the Future of Clinical... ...Prepare and maintain study documentation and ensure compliance with... ...trial processes, and regulatory requirements. Exceptional stakeholder... ...discipline. Experience in medical imaging and/or MR physics....SeniorRegulatoryWork at office
- ...Job DescriptionGeneral Summary:The Senior Medical Director will define the clinical development strategy of... ...s brochures, and other key study documents in conjunction with other line functions... ...strategyParticipates in the preparation of regulatory documents in support of...SeniorRegulatoryFull timeSummer workRemote workFlexible hours2 days per week
$55.71k - $82.01k
...drive groundbreaking medical discoveries and invite... ...provides assistance on clinical research studies, including... ...Research is seeking a Senior Clinical Research... ...supporting study start-up and regulatory activities; recruiting... ..., and maintain study documents, including protocols,...SeniorRegulatoryFull timeTraineeshipRemote workShift work$160k - $200k
...on novel ideas.As the Senior Manager, Patient Support... ...report to the Head of Clinical Operations to serve as... ...in accordance with regulatory requirements and industry... ...site logistics, documentation, and receipt protocols... ...Hepatitis C infection, medical condition (cancer or a...SeniorRegulatoryTemporary workImmediate startRemote work$185k - $250k
...seeking two experienced Clinical Operations leaders, at the Director or Senior Director level, to... ...compliance with global regulatory standards. The ideal candidate... ...and regulatory documents. Manage overall external... ...Benefits Health Care Plan (Medical, Dental & Vision) Retirement...SeniorRegulatoryTemporary workWork experience placementWork at office2 days per week$140k - $165k
...powering the acceleration of clinical research to transform... ...Role MattersAs the Senior Manager, Clinical... ...status tracking, and documentation, escalating risks and... ...startup, feasibility, regulatory processes, protocol execution... ...officeComprehensive medical, dental, and vision...SeniorRegulatoryTemporary workWork at office2 days per week$173.2k - $272.6k
Job DescriptionThe Senior Director (Sr. Principal Scientist... ...and directing clinical research activities involving... ...monitoring, analysis, regulatory reporting, and... ...detailed development documents, presentations, budgets... ...Teamwork, Drug Development, Medical Monitoring, Scientific...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Senior Medical Director, Ophthalmology At Regeneron, we use science... ...Therapeutic Area, supporting clinical development programs from first... ...development strategy and regulatory submissions while collaborating... ...the quality of clinical documents, including investigator brochures...SeniorRegulatoryWorldwide
$160k - $185k
...Therapeutics? Entrada is a clinical-stage biopharmaceutical company... ..., accountability and documentation through review of case report... ...forms, source documents, and medical records.Support the review/cleaning... ...knowledge of ICH/GCP and regulatory requirements, with a strong...SeniorRegulatoryWork at officeLocal areaRemote work$259.3k - $350.8k
...physician drug developer in Clinical Research - Cardiovascular & Metabolism... ...therapeutic area. The Sr. Medical Director, Clinical Research... ...a matrix organization across Regulatory, Biostatistics, Clinical... ...informed consent forms, briefing documents, regulatory submissions,...SeniorRegulatoryFull timeTemporary workLocal areaFlexible hours$305.7k - $413.7k
...opportunity to provide clinical leadership in... ...development programs.The Senior Director, Clinical Research... ...matrix organization across Regulatory, Biostatistics,... ..., Regulatory Affairs, Medical Affairs and Commercial... ...respect to all controlled documents including protocols,...SeniorRegulatoryFull timeTemporary workLocal areaFlexible hours$178.5k - $257.83k
Job title: Senior Clinical Outcomes Assessment (COA) LeadLocation: Cambridge... ...books or dossiers for regulatory consideration of COAs. Internal... ...Value Assessment (HEVA), Medical Affairs, Market Access, Biostatistics... ...programs, reviewing documents, representing the COA team in...SeniorRegulatoryFull timeLocal area
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