Director, Medical Writing & Regulatory Strategy
Corcept Therapeutics
Corcept Therapeutics is seeking a Director-level Regulatory Medical Writer to lead strategic medical writing for NDA submissions and regulatory documents in a fast-paced, small company environment. You will manage a team and external vendors, define content standards, and ensure high-quality deliverables across multiple therapeutic areas, including NDA submissions and clinical study reports. #J-18808-Ljbffr Corcept Therapeutics
$200k - $265k
...community. Summary of Job (brief description)The Associate Director/Director, Medical Affairs Strategy will manage the medical affairs strategic plans for... ...and external stakeholders.In-depth knowledge of the regulatory environment and compliance requirements related to...MedicalRegulatory- Who We AreNoah Medical is building the future of medical robotics.... ...You will lead the "upstream" strategy—identifying unmet clinical needs... ..., software, AI, and strict regulatory environments to deliver... ...protocol development, and report writing. Act as a subject matter expert...MedicalRegulatoryFull timeWork at officeLocal areaRemote workWorldwideFlexible hours
$2,994 per month
...intergovernmental and regulatory agencies and various public... ...; develops bargaining strategies in response to... ...Chief and the Board of Directors on progress of negotiations... ...and appeals, Retiree Medical Reimbursements, and... ...keeping, technical report writing, and preparation of...MedicalRegulatoryContract workTemporary workFor contractorsWork experience placementWork at officeLocal area$243.1k - $314.6k
...the lives of patients for generations to come. As the Director, US Medical Affairs, Liver Strategy, at Gilead you are a critical strategic and... ...communications.Partner cross-functionally with Legal, Regulatory, Commercial, HEOR, GMA, Clinical, Training, and Operations...MedicalRegulatoryFull timeFor contractorsLocal area$185k - $205k
...Associate Director, Toxicology... ...nonclinical toxicology strategies, overseeing GLP and non... ...toxicology components of regulatory submissions, and responding... ...publications, regulatory writing experience, or presentations in relevant medical and life science forums...MedicalRegulatoryWorldwideFlexible hours$226k - $280k
...with significant unmet medical need. For more... ...to join the company as Director, Toxicology. This individual... ...will provide toxicology strategy and executional... ...candidate selection, regulatory submissions, and clinical... ...Excellent scientific writing, presentation, communication...MedicalRegulatoryContract workWork at officeRemote workShift work2 days per week3 days per week- ...Job DescriptionThe Associate Director US Medical Affairs, Patient Access and... ...of Medical Affairs (MA) strategies and Plans of Action (POA) within... ...research including writing research protocols, partnering... ...preferredSolid working knowledge of regulatory and compliance...MedicalRegulatoryFull timeFor contractorsLocal area
$183.5k - $242.8k
...will collaborate with colleagues to write and/or oversee the development of... ...-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical... ...PharmD, or MS) preferred 10+ years (Director) of regulatory medical writing experience...MedicalRegulatoryFull timeFor contractors$200k - $269.8k
...Associate Medical Director/Medical Director, Endocrinology and Metabolism Redwood City, California... ...cycle (Phase1-3) Participate in the writing and review of clinical protocols,... ...clinical operations, safety, biometrics, regulatory, medical writing, to achieve project...MedicalRegulatoryFull time$229.3k - $269.8k
...To learn more, visit As an Associate Medical Director, you will support the ongoing and planned... ...III Develop and participate in the writing and review of protocols, investigator brochures... ..., study reports and other clinical and regulatory documents Establish and approve...MedicalRegulatoryFull time$211k - $264k
...motivated and scientifically rigorous Director of Biostatistics to our Medical Analytics and Exploratory Data... ...and supports medical and scientific strategy.Provide statistical leadership for... ...safety, statistical programming, regulatory affairs and commercial.Lead the...MedicalRegulatoryFull timeContract workCasual workLocal area$244k - $305k
...creative and collaborative Senior Director to work in a fast-paced... ...support clinical development strategy and programs through product... ...Biostatistics, Biomarker Operations and Regulatory on study design and protocol... ..., Biostatistics, and Medical Affairs to develop plans for...MedicalRegulatoryFull timeLocal areaWorldwide- ...patients, at the right time.The Director of Epidemiology &... ...complex, non-linear data into regulatory-grade insights that accelerate... ...ISPOR, ISPE, and ASCO.Client Strategy & Partnership: Partner with Key... ...compensation, restricted stock units, medical and other benefits depending...MedicalRegulatoryFull timeRemote work
$244k - $305k
...enable informed development decisions and global regulatory filings. The successful candidate will:Lead nonclinical safety strategy for multiple drug development programs... .../ancestry, age, disability, marital status, medical condition, and veteran status.Revolution Medicines...MedicalRegulatoryFull timeLocal areaWorldwide$244k - $305k
...pathway.The Opportunity:The Senior Director, HEOR/RWE is responsible for developing the strategy and executing HEOR plans and... ...will work closely with the Medical Affairs team as well as other cross... ...with development, commercial, regulatory, and market access planning.Deliver...MedicalRegulatoryFull timeLocal area$211k - $264k
...quality by design (QbD), to enable regulatory starting materials designation, establish control strategy and process characterization... ...and geographic diversity.Write, review, and approve protocols,... ...age, disability, marital status, medical condition, and veteran status.Revolution...MedicalRegulatoryFull timeWork experience placementLocal area$244k - $305k
...signaling pathway.The Opportunity:The Senior Director, Global Value, Access & Pricing NSCLC... ...global value, access, and pricing strategies for Revolution Medicines’ oncology... ...with Clinical Development, HEOR, Medical Affairs, Regulatory, Commercial, Finance, regional teams,...MedicalRegulatoryFull timeLocal area$186k - $233k
...pathway.The Opportunity:The Associate Director, Compliance - Field... ...leading the field-facing compliance strategy and program for Commercial and Medical field organizations during product... ...trends, enforcement actions, and regulatory developments.Serve as a senior presenter...MedicalRegulatoryFull timeLocal area$167k - $208.75k
...highly experienced Associate Director, CDx Partnership Program Management... ....Translate partner strategy, priorities, expectations, and... ...and the activities, timelines, regulatory considerations, resources, and... ...awardsComprehensive health benefits (medical, dental, vision)401(k) with...MedicalRegulatoryImmediate startRemote workWorldwide$230k - $245k
Position Summary Director, Medical Writing works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other... ...and manages medical writing service providers to develop regulatory documents, including but not limited to clinical study...MedicalRegulatoryLocal area$170k - $198k
...Analytical organization as Associate Director, CMC Statistician. The... ..., MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and external... .../pharma, excellent technical writing and communication skills, and... ...specification-setting strategy for drug substance, drug product...RegulatoryRemote work$186k - $233k
...therapies to patients. The Associate Director, Environmental Health &... ..., and interfacing with regulatory authorities as needed.Support... ...support execution of departmental strategy, identify program gaps, and... ...disability, marital status, medical condition, and veteran status...MedicalRegulatoryFull timeLocal areaFlexible hours$186k - $233k
...The Opportunity:The Associate Director in Clinical Biomarker... ...interpretation of clinical biomarker strategies across Revolution Medicine’s... ...biomarker plans, and other regulatory documents.Participate in... ...disability, marital status, medical condition, and veteran status...MedicalRegulatoryFull timeContract workLocal area- ...Supports the VP of People/Director of Human Resources in resolving... ...collaboration with the VP, develops the strategy, workflow, and management of... ...of trends, best practices, regulatory changes, and new technologies... ...personal, financial, and medical information.A strong...MedicalRegulatoryCasual workWork at officeLocal areaVisa sponsorshipWork visaRelocation packageAfternoon shift
$186k - $233k
...use in combination treatment strategies. As a new member of the... ...Opportunity:As an Associate Director, you will be responsible for... ...Clinical Practices (GCP) and regulatory requirements.SME for Clinical... ...disability, marital status, medical condition, and veteran status...MedicalRegulatoryFull timeWork at officeLocal area$215k - $235k
...is currently seeking a Senior Director, In Vivo Pharmacology to... ...the team Develop preclinical strategy for advancing Earli’s candidate... ...author nonclinical sections of regulatory filings, including the... .... Significant experience in writing regulatory documentation to support...RegulatoryLocal area$215.9k - $327.9k
Senior Director, Executive Compensation Join Electronic Arts to shape... ...public and private entity strategies and designs to support... ...compensation programs, including regulatory and compliance... ...time, holidays, family leave, medical/dental/vision insurance, life...MedicalRegulatory$186k - $233k
...pathway.The Opportunity:The Associate Director, Global Regulatory Affairs Project Management is an... ...for translating global regulatory strategies into actionable execution plans. This... ...Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics...MedicalRegulatoryFull timeWork at officeLocal area- ...and positive play. As Senior Director, Executive Compensation, you... ...public and private entity strategies and designs to support enterprise... ...programs, including regulatory and compliance considerations... ...time off to bond with baby, medical/dental/vision insurance, life...MedicalRegulatoryFull timeLocal area
$186k - $233k
...Diagnostics team as an Associate Director, Companion Diagnostics... ...implement global diagnostic strategies to enable and support the global... ...and commercialization of medically differentiated therapies. The... ...of overarching development, regulatory and commercialization...MedicalRegulatoryFull timeLocal area
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