Medical Writer — Regulatory & Clinical Documents Expert
Scorpion Therapeutics
Scorpion Therapeutics is seeking a skilled medical writer to design, plan, author, edit, and review clinical regulatory and public-facing documents, ensuring clarity and compliance across projects. You will collaborate with cross-functional teams, anticipate regulatory expectations, and contribute to process improvements while expanding knowledge of clinical development and writing tools. #J-18808-Ljbffr Scorpion Therapeutics
- Scorpion Therapeutics is seeking a Health Literacy Medical Writer to develop, author, and lead review of accurate, clear, compliant clinical, regulatory, and public-facing documents. You will prepare clinical regulatory materials and plain-language summaries, including...DocumentRegulatory
$117k - $184.2k
Job Description The Clinical and Regulatory Strategic Communications (CRSC) department... ...plain language summaries) documents per company and evolving... ...that reflect applicable medical writing best practices (e.g... ...mentoring less experienced writers. May manage direct reports,...DocumentRegulatoryFor contractorsWork at officeLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Health Literacy Medical Writer Responsibilities: Develop, author, and lead review of accurate, clear, compliant clinical, regulatory, and/or public-facing documents. Prepare clinical regulatory (e.g., clinical study reports, participant narratives, investigator’s brochures...DocumentRegulatoryWork at office
- ...Principal Medical Writer The Clinical and Regulatory Strategic Communications (CRSC) department within Global... ...regulatory, and/or public-facing documents, across multiple programs and therapeutic... ...Is recognized as a subject matter expert in the design, planning, authoring...DocumentRegulatoryWork at office
- ...Principal Medical Writer ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving... ...study reports, protocols, and other regulatory documents to ensure accuracy and clarity Collaborating...DocumentRegulatoryFlexible hours
- ...The Principal Medical Writer is a key leadership position... ...more Programs within Clinical Development. The incumbent... ...clinical safety and regulatory requirements of a... ...studies and related documents for their ability to... ...grammar and punctuation. Expert MS Office skills with...DocumentRegulatoryContract work
- ...Medical Writer Position A Few Words About Us Integrated... ...Technology (IT), Clinical Research, Rehabilitation... ...therapeutic summaries, regulatory responses, internal... ...risk/benefit briefing documents, for one or more... ...nonscientific audiences. Applies expert knowledge, analytical...DocumentRegulatoryContract work
- ...The Principal Medical Writer is a key leadership position... ...more Programs within Clinical Development. The incumbent... ...clinical safety and regulatory requirements of a... ...studies and related documents for their ability to... ...grammar and punctuation. Expert MS Office skills with...DocumentRegulatoryContract work
- ...Function: Discovery & Pre-Clinical/Clinical... ...immune diseases. The Medical Director provides medical... ...-quality clinical and regulatory deliverables.Key Responsibilities... ...and review clinical documents, including study... ...investigators, external experts, patient organizations...DocumentRegulatoryFull timeLocal areaImmediate start
$142.4k - $224.1k
...DescriptionThe Associate Director Clinical Scientist provides scientific... ...Managers, Clinical Operations, Medical Monitoring, Data Management, Statistics, and Regulatory colleagues to ensure scientific... ...plans, and other study-related documents across assigned studies or...DocumentRegulatoryFull timeFor contractorsLocal areaFlexible hours- ...Excellent employment opportunity for a Medical Writer III in the Spring House, PA area. Ensuring... ...directly with scientists within Early Clinical Development and Translational Research to write clear and concise guidance documents that summarize immune phenotyping /...DocumentContract work
- ...Clinical Research Associate - Early Development Multi Therapeutic... ...regulations Maintain up-to-date documentation in CTMS and eTMF systems... ...in ICH-GCP, local regulatory requirements, and clinical systems... ...status. If, because of a medical condition or disability, you...DocumentRegulatoryLocal areaWorldwideVisa sponsorshipFlexible hours
$139k - $238.05k
...Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub... ...prioritization, and biomarker support of regulatory filings. It has expertise in... ..., and other study documents.Lead central and specialty laboratory... ..., Clinical Pharmacology, Medical Writing, regional...DocumentRegulatoryFull timeContract workTemporary workLocal area- ...Clinical Quality Control Reviewer A Few Words About Us - Integrated... ...components of assigned documents (eg, clinical study reports,... ...manuscripts, summary documents, regulatory responses, etc.). Formally... ...include a minimum of 3 years medical writing and DQR/QC experience...DocumentRegulatoryImmediate start
$110.52k - $138.15k
...Senior Clinical Research Associate ICON is a global healthcare... ...complete reports and maintain documentation Submitting protocol,... ...approval, as well as preparing regulatory submissions Balancing sponsor... ...to review and evaluate medical data ~ Excellent written and...DocumentRegulatory$96.01k
...Job title: SR. Clinical Data Manager Location: King of Prussia... ...Serve as the subject matter expert for the planning, set-up,... ...3rd Party Data Acquisition documentation in TMF. • Follow procedural... ...reflective of industry standards and regulatory requirements and include...DocumentRegulatoryFull time- ...reporting outputs (tables, listings, and figures) for clinical trials in alignment with project requirements and regulatory standards. • Build and maintain analysis... ...workflows. • Lead the review of key study documentation including statistical analysis plans (SAP),...DocumentRegulatory
- ...with 3-5 years of experience and preferred pharmaceutical expertise. The role involves preparing local product documents and ensuring compliance with regulatory standards. The ideal candidate will communicate effectively, prioritize tasks, and support various labeling...DocumentRegulatoryLocal area
$142.4k - $224.1k
...Medicine (TMed) drives early clinical development of novel therapeutics... ...with GCP, ICH, and regulatory requirements, supporting study... ...other clinical and regulatory documents. Authors and coordinates the... ...clinical site training/monitoring; medical and regulatory...DocumentRegulatoryFull timeFor contractorsLocal areaWorldwideFlexible hours$150 per hour
...or Sub-I on sponsor-initiated clinical trials. This role will lead... ...Responsibilities Accurately document findings and contribute to... ..., and all applicable regulatory requirements. Lead and supervise... ...assessments, including physical exams, medical histories, and eligibility...DocumentRegulatoryContract workPart timeFor contractorsLocal areaRemote workFlexible hours- ...Clinical Scientist A Few Words About Us Integrated Resources, Inc is a premier staffing... ...The supporting clinician will provide medical and scientific study and project... ...• Safety review and communication • Regulatory document, study report and publication preparation...DocumentRegulatory
$239.9k - $399.8k
...Job SummaryThe medical director provides Clinical Development leadership and expertise... ...other functions such as regulatory affairs, pharmacovigilance... ...trial and regulatory documents, in collaboration with Clinical... ...closely subject matter experts within cross-functional...DocumentRegulatoryPermanent employmentFull timeInternshipH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...CSL Behring in King of Prussia, PA, seeks a Principal Medical Writer to lead medical writing strategy for one or more clinical Programs, ensuring high-quality, strategically aligned deliverables for regulatory submissions. This role partners with cross-functional teams...Regulatory
$143.01k - $168.47k
...fight against MASH.Madrigal’s medication, Rezdiffra (resmetirom), is... ...time, in the right way.The Clinical Trial Manager is an experienced... ...with ICH-GCP, applicable regulatory requirements, and company SOPs... ..., and finalize key study documentation including study plans, operational...DocumentRegulatoryMinimum wageFull timeWork at officeLocal areaFlexible hours- ...environment that prioritizes clinical excellence, innovation... ...patient care plans, documenting interventions... ...Maintain compliance with all regulatory and safety standards,... ...package including medical, dental, and vision plans... ...Orthopaedics delivers expert treatment for...DocumentRegulatoryFull time
- ...Clinical Services Coordinator Penn Medicine is dedicated... ...this leading academic medical center means... ...CSC serves as the EMR expert and the liaison between... ...federal, state, and local regulatory standards (ex OSHA,... ...patient's vital signs and documents in EMR, prepares chart...DocumentRegulatoryFull timeWork at officeLocal area
$61k - $155k
...strong expertise in SAS and a solid understanding of CDISC standards. The ideal candidate will have 5-7 years of experience in the clinical domain. This position offers a pay range from $61,000 to $155,000 per year, plus potential performance-based bonuses and...- ...Working for this leading academic medical center means collaboration with top clinical, technical and business... ...patients in exam rooms, updating documentation, and cleaning and sterilizing equipment... ...outdated items. Other / Regulatory: Ensures compliance with all applicable...DocumentRegulatoryFull timeLocal area
$213k - $260k
...fight against MASH.Madrigal’s medication, Rezdiffra (resmetirom), is... ...to the Vice President, Clinical Safety & Aggregate Reporting... ...relevant sections of study documents including Protocol, Informed... ...sections of submission filings and regulatory responses including but not...DocumentRegulatoryMinimum wageFull timeLocal areaFlexible hours$288k - $352k
...fight against MASH.Madrigal’s medication, Rezdiffra (resmetirom), is... ...way.The Executive Director, Clinical Scientist, supports the... ...through development and toward regulatory milestone, the Executive Director... ...or review key clinical documents such as investigator brochures...DocumentRegulatoryMinimum wageFull timeLocal areaFlexible hours
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