Medical Writing Lead - Regulatory Submissions & Strategy
Brio Group
Brio Group seeks an experienced Lead Medical Writer located in California, Missouri. This role requires a minimum of 8 years of medical writing experience in the biotech/pharma/CRO sector. Responsibilities include authoring key documents for clinical trials, ensuring all deliverables meet global regulatory standards, and collaborating with various departments for alignment on strategies. Candidates with a strong background in clinical and regulatory documents are preferred. Join Brio Group to contribute to regulatory submissions and drive best practices in medical writing. #J-18808-Ljbffr Brio Group
- ...the United States is seeking a Principal / Senior Medical Writer with proven clinical document writing experience to lead complex regulatory deliverables, including protocols, reports, patient narratives, and submissions. You will ensure scientific accuracy, timely...MedicalRegulatory
- ...BioRobotics in California is seeking a Staff Regulatory Affairs Specialist to lead regulatory initiatives for medical robotics, focusing on compliance and innovation... ...discipline, extensive experience in regulatory submissions for medical devices, and strong problem-...MedicalRegulatory
$125k - $175k
...Building Materials Practice Lead California Description... ...and navigating regulatory requirements. The Role... ...assessments, and regulatory submissions related to hazardous... ..., and proposal writing. Commitment to continuous... ...benefits package including Medical, Dental, Vision,...MedicalRegulatoryLocal areaFlexible hours- Lead cross-functional teams of senior leaders within Pfizer R&D... ...capabilities Responsible for strategy, business case, deployment and... ...in a relevant scientific/medical discipline 12+ years clinical... ...conduct, clinical, monitoring and regulatory operations Experience leading...MedicalRegulatory
- ...California is seeking an Associate Director, Medical Writing to provide expertise in preparing clinical and regulatory documents for health authority submissions. This strategic role requires... ...and outcomes for cancer patients by leading medical writing initiatives. #J-188...MedicalRegulatory
$10k
...dollar. We are hiring a Lead Product Marketing... ...the vertical portfolio strategy. Build the business cases... ..., buying dynamics, regulatory requirements, technology... ...everyday research, analysis, writing, and operating... ...stipend United States 100% medical, dental & vision...MedicalRegulatoryFull timeWork at officeRelocationHome officeFlexible hours- ...Auditor to ensure GCP compliance across its trial operations. The role collaborates with Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing, and Data Management to maintain readiness and uphold quality standards. The ideal candidate has extensive GCP,...MedicalRegulatoryRemote job
$50 - $67 per hour
...0/hr - $67.00/hr Sr. Regulatory Specialist Fully remote... ...contributor to FDA submissions (PMA/510(k)) and requires... ...excellent scientific writing, knowledge of IVD product... ..., carryover, controls strategy) and author clear,... ...Biotechnology Research, and Medical Equipment...MedicalRegulatoryContract workRemote work- Lead authoring of key documents (protocols, CSRs, IBs) across... ...IV. Partner with Clinical, Regulatory, and Biostats to align on timelines and strategy. Ensure all deliverables... ...and best practices across medical writing. Contribute to submission readiness and regulatory filings...MedicalRegulatory
- ...Evaluation Reports (CERs). This role requires a strong background in medical writing, ability to conduct literature reviews, and collaborate with cross-functional teams to deliver important regulatory documentation. Candidates must have an MD, PhD, or M.S. in a scientific...MedicalRegulatory
$100k - $140k
...referencing, annotating, and submissions to enable a smooth MLR... ...plans including objectives, strategies, and how success will be... ...demonstrating strong and consistent writing ability. Proficient in... ...‑checking, prepping for medical/legal/regulatory submissions (preferred)....MedicalRegulatoryFreelanceWork at officeLocal area$13.31k
...Attorney IV takes the lead on breaches or... ...engages in litigation strategy. The Attorney IV,... ..., procedural, regulatory issues and projects... ...communicate effectively in writing and audibly in... ...to excellent medical, dental and vision... ...Electronic application submission is highly...MedicalRegulatoryPermanent employmentFull timePart timeWork at officeLocal areaRemote workVisa sponsorshipWork visaNight shift- Faro Health Inc. is seeking an experienced medical writer to shape an AI-enabled authoring product for clinical and regulatory documents. You will influence product design, workflows and quality benchmarks, working with Product, Engineering and Clinical teams in a fast-...MedicalRegulatory
- ...Research International LLC is seeking a Vice President of Regulatory Strategy in California. This role involves supervising teams, developing... ..., and a proven record in managing successful regulatory submissions. Competitive salary and comprehensive benefits are offered....Regulatory
$163k - $245k
...seeking an experienced MSL Manager to lead a team of Medical Science Liaisons focused on lysosomal... ...disorders. You will drive medical strategy, mentor staff, recruit and onboard new... ...collaborate with Clinical Development, Regulatory Affairs and Commercial teams to align...MedicalRegulatoryRemote jobRelocation package$83.98 - $111.27 per hour
...services provided and assures compliance with regulatory requirements. Project Management and... ...monitor pharmacy practices to optimize medication management outcomes for patients.... ...communicate effectively, both orally and in writing procedures and communication to coworkers...MedicalRegulatoryHourly payFull timeWork experience placement$160k - $200k
Senior Business Development Director - Regulatory & Medical Writing The Senior Business Development... ...consultative solutions including regulatory strategy, submission support, regulatory operations, and... ...writing. Responsibilities Lead strategic sales efforts, identify...MedicalRegulatoryBase plus commissionContract workWork at officeRemote workFlexible hours$114k - $228k
Regulatory Affairs Manager - APAC - Diabetes... ...healthcare, with leading businesses and products... ...in diagnostics, medical devices,... ...global regulatory strategies, working with cross... ...compiling regulatory submissions, and ensuring... ...experience.* Scientific writing experience.*...MedicalRegulatoryShift work- ...is seeking a seasoned influencer marketing professional to lead campaign strategy and talent partnerships. You will source and evaluate creators... ...compelling content briefs, and work with Legal to ensure regulatory compliance. You will analyze campaign performance and...Regulatory
$100.32k - $125.4k
...span both consumer and medical solutions and the... ...International (China) Regulatory Affairs 164201 Senior... ...approvals, preparing local submissions, supporting in-country... ...international registration strategy and submissions •... ...registrations • Strong writing, proofreading,...MedicalRegulatoryTemporary workWork experience placementWork at officeLocal areaRemote workFlexible hours- ...to Manger/Sr. Manager, Medical Sciences and requires... ...collaboratively to develop strategies for the creation of... ...in support of submission for CE Mark application... ...product development, regulatory, post‑market surveillance... ...scientific literature and write clinical summaries for...MedicalRegulatoryLocal areaWorldwide
- A leading pharmaceutical company is hiring a Sr. Regulatory Specialist for a fully remote position. This role requires a Ph.... ...shape study designs, and prepare submission-ready documentation for FDA submissions. Strong scientific writing and communication skills are essential...RegulatoryRemote jobFlexible hours
$104.4k - $157.4k
...Workplace Experience Manager, Site Lead Los Angels-Del Ray - Onsite... ...studio. This role leads the strategy and delivery of the workplace... ...Ensure adherence to safety, regulatory, and company policies.... ...time off to bond with baby, medical/dental/vision insurance, life...MedicalRegulatoryFull timeLocal area$130.7k - $261.3k
## Senior Regulatory Affairs Manager - Digital... ...healthcare, with leading businesses and... ...in diagnostics, medical devices, nutritionals... ...regulatory submissions and ensure data is... ...Work On**Regulatory Strategy & Product Lifecycle... ...verbally and in writing, prepare, and negotiate...MedicalRegulatoryWork experience placementWorldwideShift work$260k - $390k
...interviews. Draft pleadings, write complex briefs, and regularly... ...trial preparation and courtroom strategy. Collaborate seamlessly... ...Property, Data Security, and Regulatory Disputes Qualifications & Requirements... ...equity. Benefits: Robust medical, financial, and alternative...MedicalRegulatoryFull time- A medical malpractice litigation firm is seeking a Litigation Attorney to manage all aspects of case work, except trial presentations... ...with trial attorneys to prepare pleadings, develop discovery strategies, attend court appearances, and respond to inquiries. The ideal...Medical
- Lead strategic planning for Pfizer's global R&D real estate portfolio Develop and implement... ...utilization, and workplace experience strategies across global R&D Advise Therapeutic... ...space considerations Knowledge of regulatory requirements and industry best practices...RegulatoryPermanent employmentFlexible hours
$149.04k - $195.62k
...will translate market strategy into applicable benefit structures, leading agreement, and ensuring... ...performance insights, and regulatory requirements into clear... ...regulatory filing submission, approval, and objection... ...for benefits including: medical, dental, and vision benefits...MedicalRegulatoryFull timeRemote workWork from home- Tarsus Pharmaceuticals, Inc. is looking for an Associate Director, Medical Strategy & Education based in Irvine, California. You will play a pivotal role in driving the medical strategy through insight collection, education initiatives, and effective KOL engagements. With...Medical
$72.2k - $100k
The Lead Site Clinical Research Coordinator (CRC) is the founding coordinator for Salma... ...guidelines. The CRC may also support regulatory submissions across Salma Health trials, including... ...in a timely manner Abstract and review medical records to support source document...MedicalRegulatory
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