Senior Medical Writing Lead - Regulatory Documents
structuretx
Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead regulatory and clinical document development, ensure regulatory compliance, and manage multiple projects in a fast-paced environment. You will provide strategic guidance on writing templates, perform QC reviews, collaborate with Clinical Sciences, Regulatory Affairs, Biostatistics, and Program Management, and mentor other writers. #J-18808-Ljbffr structuretx
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Medical Writing Lead - Regulatory Documents in South San Francisco, CA vacancy
- Structure Therapeutics Inc. is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. You will oversee authoring, reviewing, and finalizing pivotal documents and ensure compliance with FDA, EMA...DocumentSeniorMedicalRegulatoryRemote job
- A biotech research company in South San Francisco seeks an Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory documents. The ideal candidate must possess a Master's degree and over 8 years of experience in scientific writing...DocumentSeniorMedicalRegulatory
- Merck & Co. is seeking an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. The role focuses on generating preclinical reports... ...programs, with collaboration across research and regulatory functions. The successful candidate will manage...DocumentSeniorMedicalRegulatory
- Cynosure Staffing in California is seeking an Associate Director, Medical Writing to lead and oversee the creation and review of high-quality clinical and regulatory documents in compliance with ICH and global guidelines. The role emphasizes project leadership, cross-functional...DocumentSeniorMedicalRegulatory
- Structure Therapeutics is seeking an Associate Director of Medical Writing to lead the development of regulatory and clinical documents for its drug programs. The role requires expertise in regulatory writing, QC, and cross‑functional collaboration to ensure compliant,...DocumentMedicalRegulatory
$117k - $184.2k
...collection. Applies GCP, ICH, and regulatory requirements. Represents... ...promotes best practices. Technical writing: Co-authors protocols,... ...; develops study operational documents. Project management: Manages... ...execution; site training/monitoring; medical/regulatory writing). Required...DocumentSeniorMedicalRegulatoryScorpion Therapeutics
South San Francisco, CA13 hours ago- ...curable and no longer the leading cause of death in the... ...Development, the Senior Director, Clinical... ...development, supporting regulatory submissions, and... ...Phase meetings, briefing documents, and future NDA submissions... ...Regulatory Affairs, Medical Writing, CMC, Research, and...DocumentSeniorMedicalRegulatory
$360k - $420k
...instrumental in providing medical leadership and... ...Responsibilities: Lead the development, execution... ...clinical development and/or regulatory approval. Provide... ...and/or regulatory documents (e.g., study protocol,... ...NDA). Experience in writing clinical sections of regulatory...DocumentSeniorMedicalRegulatoryContract workFlexible hoursLycia Therapeutics
South San Francisco, CA6 days ago$270k - $360k
Medical Director/Senior Medical Director, Clinical Development TenvieTherapeutics... ...‑on Medical Director to lead early‑ and mid‑stage... ...high‑quality clinical and regulatory documentation Lead or oversee authoring... ...Excellent scientific and medical writing skills; able to produce...DocumentSeniorMedicalRegulatoryLocal areaRemote work$258k - $361k
...team has secured partnerships with leading global biopharmaceutical... ...Description Primary Function: The Senior Director, Medical Writing leads the Medical Writing function... ...authorship and oversight of clinical and regulatory documents across all phases of drug...DocumentSeniorMedicalRegulatoryContract workWorldwideRelocation packageZai Lab (US) LLC
South San Francisco, CA25 days ago$170k - $200k
...highly motivated Senior Clinical Scientist... ...scientific data, regulatory landscape, and expertise... ..., clinical documents for regulatory submissions... ...Clinical, Medical, Clinical Operations... ...teamwork; ability to lead team activities... ...terminology and medical writing skills Knowledge...DocumentSeniorMedicalRegulatoryWork at officeShift work2 days per week3 days per week$125k - $180k
...Clinical Scientist/Senior Clinical Scientist... ...Translational Science, and Regulatory to ensure high‑... ...: Lead development of core clinical documents Author or co‑author... ...training material, medical monitoring plans, safety... ...Excellent scientific writing skills with a track...DocumentSeniorMedicalRegulatoryFull timeLocal areaRemote workTenvie Therapeutics
Brisbane, CA28 days ago$143.07k - $162k
...today and address the medical challenges of tomorrow... ...Tok. Job Description Senior Scientist 1, Bioassay... ...partners & author technical documents (e.g. test methods,... ...& reports) to enable regulatory submissions). Develop... ..., drafting SOPs, writing CMC sections of regulatory...DocumentSeniorMedicalRegulatoryTemporary workWork experience placement$270k - $334k
...IDEAYA is seeking a Senior Director of Safety... ...Development, Regulatory Affairs, Data Management... ...What you’ll do: Lead the Biometrics... ...and program level documents. Manage and/or oversee... ...experience from writing complex protocols... ...board approval). medical/dental/vision coverage...DocumentSeniorMedicalRegulatoryContract workTemporary workInterim roleWork at officeLocal areaWork from home- ...today and address the medical challenges of... ...highly motivated Senior Scientist II to join... ...this role, you will lead laboratory-based... ...workflows, procedures and documentation to enable... ...documentation, and regulatory support documents... ...including technical writing and scientific...DocumentSeniorMedicalRegulatoryFull timeLocal area
AbbVie Inc.
South San Francisco, CAmore than 2 months ago - ...Senior Manager, Biostatistics Working with... ...preparation of regulatory submissions. These... ...the Biostatistics Lead, and other cross functional... ...specification documents with minimum... ...interpersonal, communication, writing and organizational... ...Health Coverage: Medical, pharmacy, dental,...DocumentSeniorMedicalRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hoursShift work
Bristol-Myers Squibb
Brisbane, CA1 day ago $131.4k - $206.8k
...We are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group responsible for the generation... ...with various research and regulatory functions to prepare high-... ...Contribute to the development of writing templates, best practices,...DocumentSeniorMedicalRegulatoryFor contractorsWork at officeLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Central Reading Centers, Labs, Medical Coders). Author key documents, including Data Management... ...-ready manner. Support Lead Clinical Programmers in... ...Managers, Programming, and Regulatory teams. Review study protocols... ...skills, with experience writing Data Management Plans,...DocumentSeniorMedicalRegulatory
Katalyst CRO
San Francisco, CA13 hours ago - ...Senior Firmware Test Engineer San Mateo, CA... ...Design, develop, and document test tools, methods, and... ...oscilloscopes. ~ Experience writing test protocols,... ...~ Prior experience in medical device development, including... ...external labs for regulatory testing, including EMC...DocumentSeniorMedicalRegulatoryFull time
Cala Health
San Mateo, CA13 hours ago - ...immune diseases and cancer. Our lead program, soquelitinib, is a... ...individual study protocols Writes or assists in writing of... ...Brochures, DSURs and other regulatory documents Assist other team members in... ...conduct of trial Assist in Medical Monitor responsibilities Work...DocumentSeniorMedicalRegulatoryWork at officeImmediate start
- ...Description The Role: The Medical Writer will serve as an important... ...Biosciences' Clinical and Regulatory Affairs teams, responsible... ...quality clinical and regulatory documents. Reporting directly to the... ..., this individual will lead the writing of clinical study reports, regulatory...DocumentSeniorMedicalRegulatoryContract workInterim roleWork at office
Sagimet Biosciences
Foster, CA4 days ago - ...Job Title: Senior Clinical Scientist Location... ...critical unmet medical needs. We're looking... ..., Data Science, Regulatory and Quality teams,... ...intraoperative FIH study. Lead study strategy,... ...clinical documents for current and future... ...Excellent scientific writing, critical-thinking...DocumentSeniorMedicalRegulatoryFull timeFlexible hours
Black Inc
San Francisco, CA1 day ago - ...PV Clinical Scientist leads clinical review of USPS... ...) based on their medical assessment Performs... ...and developing training documents (i.e., SOPs) for the targeted... .../Pharm D, or MD) Writing experience; science/... ...and other applicable regulatory guidance documents,...DocumentSeniorMedicalRegulatoryContract workLocal areaFlexible hours
SGA
South San Francisco, CA3 days ago $157.59k - $203.94k
...Senior Manager, Quality Assurance At Gilead... ...laws and regulatory requirements, and... ...templates, guidance documents, training materials... ...remediation activities Leads or contributes to... ...strong technical writing skills with the... ...company-sponsored medical, dental, vision, and...DocumentSeniorMedicalRegulatoryContract workGILEAD
San Mateo, CA13 hours ago$184.6k - $225k
...seeking a Sr. Manager/Lead Systems & Data Architect... ...teams and influencing senior stakeholders across the... ...aligned with enterprise and regulatory needs. Optimize... ...we offer: Comprehensive medical, dental, vision, disability... ...provide legal advice, document creation and estate planning...DocumentSeniorMedicalRegulatoryFull timeLocal areaFlexible hours$59.1k
...and maintain all documentation including obtaining... ...reports suitable for senior management... ...effectively orally and in writing; negotiate complex... .... Ability to lead research teams;... ...will comply with regulatory minimum wage rates... ...to a disability, medical condition, or physical...DocumentSeniorMedicalRegulatoryMinimum wageContract workTemporary workWork experience placementRemote workMAXIMUS
San Francisco, CA1 day ago- Rigel Pharmaceuticals seeks an Associate Director of Medical Communications and Publications to lead strategic publication planning and publication... ...biostatistics, clinical development, medical affairs, regulatory) and manage external agencies, vendors, and #J-1880...SeniorMedicalRegulatory
$135k - $145k
...program goals.Supports the Study Lead as an integral member of a... ...amendments, and works with medical writing to initiate protocol... ...development of critical study documents such as informed consent form... ...protocol and study drug, safety, regulatory, and legal questions....DocumentSeniorMedicalRegulatoryContract workWork at officeRemote workStructure Therapeutics
South San Francisco, CAa month ago$260k - $275k
...Summary: The Senior Director, Quality... ...reports, and other GMP documentation. The role partners... ...Quality Control, Regulatory, Clinical Supply,... ...Responsibilities: Lead implementation and... ...Strong technical writing, investigative,... ..., family medical history or genetic...DocumentSeniorMedicalRegulatoryFull timeContract workTemporary workFor contractorsWork at officeShift workVaxart
South San Francisco, CA10 days ago$299k - $349k
...global biopharmaceutical company in California is seeking a Senior Medical Director to lead late-stage clinical development programs in Oncology.... ...and collaboration with cross-functional teams to ensure regulatory compliance. The pay range is between $299K and $349K per...SeniorMedicalRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Medical Writing Lead - Regulatory Documents. Be the first to apply!
Related searches
- senior manager customer operations South San Francisco, CA
- senior software engineer ruby on rails South San Francisco, CA
- senior customer service South San Francisco, CA
- senior business manager South San Francisco, CA
- senior director of development South San Francisco, CA
- senior compensation manager South San Francisco, CA
- senior cloud data engineer South San Francisco, CA
- senior manager South San Francisco, CA
- senior living South San Francisco, CA
- senior vmware engineer South San Francisco, CA