Senior Medical Writing Lead - Clinical Documents & Strategy
Alnylam
Alnylam is seeking a Senior Manager, Medical Writing to collaborate with project teams on clinical document development in compliance with GCP and SOPs. The role oversees contract writers across the clinical program and ensures timely, high-quality deliverables. The candidate will plan, write, edit, and format key documents (protocols, investigator brochures, study reports, integrated safety summaries) and facilitate efficient review processes with consultants and vendors. #J-18808-Ljbffr Alnylam
$126k - $234k
...Cambridge, MA We are Clinical Sciences and Innovation... ...team, you will support or lead the clinical science... ...plans and other required documents Ensure quality conduct... ...protocol development/writing is highly desirable The... ...disabilities. If, because of a medical condition or disability...DocumentSeniorMedicalWorldwide- ...Responsibilities The Contract Sr. Clinical Scientist will ideally... ...and communicate strategy proposals well-... ...*Collaborates with medical writing to author clinically relevant... ...and/or reviews documents related to trials, such... ...with minimal support *Leads planning and prepares...DocumentSeniorMedicalContract work
$95k - $115k
...Senior Proposal Lead SMMA is seeking an experienced Senior... ...success through thoughtful strategy, strong project... ...and other procurement documents to identify requirements... ...proposal content. Write, edit, and tailor... ...funded MA Paid Family and Medical Leave ~401(k) with...DocumentSeniorMedicalWork from home- 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...DocumentSeniorMedical
- Senior Director, Medical Information Lead Our mission is to develop curative genome editing treatments... ...trends/metrics. Oversee the writing and quality of response documents for the contact center and... ...literature for findings with clinical/strategic relevance Deliver scalable...DocumentSeniorMedical
$55.71k - $82.01k
...drive groundbreaking medical discoveries and... ...provides assistance on clinical research studies,... ...into recruitment strategy, methodology... ...design, and manuscript writing. Does this... ...Research is seeking a Senior Clinical Research... ...maintain study documents, including protocols...DocumentSeniorMedicalTraineeshipRemote workShift work$163.33k - $186.67k
...a strong background leading early phase clinical trials. This individual... ...operational strategy for successful delivery... ...development of study documentation including protocol review... ...documents, and medical records. Evaluate and... ...review, and report writing Oversee TMF management...DocumentSeniorMedicalLocal areaFlexible hours- ...Senior Clinical Research Associate PROMETRIKA is a full... ...management, biostatistics, medical writing, and... ...verifiable from the source documents. The Senior CRA oversees... ...other functional area leads (e.g., protocols, model... ...the implemented risk strategies Perform study site...DocumentSeniorMedicalContract workWork experience placementWork at officeLocal areaRemote work
$139.1k - $231.9k
...scientific and clinical oversight of clinical... ...development strategy for programs... ...resourcing needs. The Senior Manager... ...other clinical and medical colleagues,... ...and regulatory documents including, but... ...submission components. Leads the clinical... ...scientific writing skills and strong...DocumentSeniorMedicalPermanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...Senior Manager, Clinical Data Management Burlington, MA Working... ..., Clinical Data Strategy and Management, will... ...Programming, Safety, Quality, Medical Writing, and external data vendors. Lead day-to-day clinical... ...activities, and documentation to ensure compliant,...DocumentSeniorMedicalInterim roleWork at office
- ...Senior Clinical Data Manager The Senior Clinical Data Manager... ...the data cleaning strategy and leads the data cleaning efforts... ...Centers, Labs, Medical Coders). Data Management Documents: Author Data Management... ...Experience writing Data Management documentation...DocumentSeniorMedical
$150.5k - $245.5k
...Regeneron seeks a Senior Manager to lead clinical study strategy for immune and inflammatory disease... ...Partner with Medical Directors to develop protocols... ...Author and review key trial documents including synopses,... ...requirements ~ Strong medical writing and clinical research...DocumentSeniorMedical- We are seeking a Senior Clinical Trial Manager with relevant Clinical... ...study deliverables. Lead external (CRO) trial management... ..., data management, medical monitoring, medical writing, statistics and safety/pharmacovigilance... ...input into study documents including clinical...DocumentSeniorMedical
$153k - $197.6k
Senior Clinical Trial Manager - Oncology Watertown, MA | Full-Time... ...tracking, study documentation, timelines and deliverables... ...final study deliverables. Lead external CRO trial management... ..., data management, medical monitoring, medical writing, biostatistics, and safety...DocumentSeniorMedicalFull timeWork at office$190k - $210k
...Lead Clinical Pathologist This is a full-time permanent, salaried... ...support for the Angell Animal Medical Center (AAMC) clinical pathology... ...emails, webpage content or documents. Participate in AAMC... ...education seminars, article writing for marketing and/or publication...DocumentMedicalPermanent employmentFull timeTraineeshipWork experience placementWork visa$150.5k - $245.5k
...diseases. We are seeking a Senior Manager, Hematology Clinical Sciences to join our... ...collaborate closely with Medical Directors and cross-functional... ...consents, and support regulatory document development Perform... ...methodology, and medical writing Strong analytical, presentation...DocumentSeniorMedicalWorldwide$150.5k - $245.5k
...We are seeking a Senior Manager to join our Clinical Sciences team,... ..., you will help lead the design, execution... ...closely with Medical Directors and... ...the scientific strategy behind clinical... ...review key trial documents, including expanded... ...Strong medical writing skills and clinical...DocumentSeniorMedicalWorldwide$168k - $188k
...close out of domestic and international clinical studies, including study concept and... ...trial-related trackers such as regulatory documents, trial master file (TMF), startup... ...Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance) Other...DocumentSeniorMedicalContract workLocal areaRemote workFlexible hours$280.6k - $420.8k
...Senior Medical Director will establish clinical development strategy for neurological assets, lead cross-functional teams through trial design and execution, and serve as medical... ...analysis plans, and regulatory submission documents Interface with regulatory authorities...DocumentSeniorMedical$84k - $202k
...The Opportunity As a Strategy& Strategy Consulting Senior Associate Intern you will support... ...from interviews, documents, and digital tools to identify... ...ideas clearly through writing, presentations, and active... ...information (including family medical history); veteran,...DocumentSeniorMedicalSummer workInternshipH1b$333.3k
...Regeneron seeks a Senior Medical Director to lead clinical development strategy for obesity programs, overseeing Phase 2/3 study design, regulatory submissions... ...signal detection Prepare and review clinical documents, protocols, investigator brochures, and regulatory...DocumentSeniorMedical- ...Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory... ...for ARTBIO’s clinical-stage radiopharmaceutical... ...regulatory medical writing across functions.... ...development data and strategy into clear,... ...submission publishing, document management, submission...DocumentSeniorMedicalContract work
- PROMETRIKA, a full-service CRO, seeks a Manager, Medical Writing to oversee the creation of regulatory documents for global drug development programs. The role includes writing and editing protocols, CSRs, and submissions, and supervising junior writers and contractors....DocumentSeniorMedicalFor contractors
$330k - $355k
...Senior Director, Clinical Development Triveni Bio is breaking new... ...inflammatory disorders. Our lead antibody program (... ...lead the clinical strategy and study execution... ...development plans, provide medical leadership across... ...INDs, CTAs, briefing documents, and NDAs/BLAs....DocumentSeniorMedicalFull timeFor contractors$150.5k - $245.5k
...Regeneron seeks a Senior Manager in Clinical Sciences to support global clinical... ...Responsibilities Partner with Medical Directors to design and... ...Author and review study documents including protocols, SAPs,... ...methodology ~ Strong medical writing, analytical, and...DocumentSeniorMedical$135k - $215k
...Opportunity Overview As a Senior Medical Communications Writer,... ...for researching, writing, and editing publications... ...overall publication strategy. This position will also... ...data analysis and document content. Oversee vendor... ...of drug development, clinical research, study designs...DocumentSeniorMedicalFreelanceWork at office$210k - $300k
...Rhythm is seeking a Senior Director,... ...supporting important clinical development programs... ...serve as the lead statistician for... ...shape statistical strategy for programs that... ...programming, and medical writing/publications teams... ...clinical and regulatory documents, including...DocumentSeniorMedicalInterim roleWork at officeFlexible hoursShift work$119.7k - $222.3k
...Sciences representative to lead the development and... ...(AI) enabled strategies to transform clinical pharmacology support... ...authoring regulatory documents. Essential Requirements... ...be considered for Senior Principal Scientist.... .... If, because of a medical condition or disability...DocumentSeniorMedical$147.9k - $200.1k
...Senior Manager, Clinical Data Management The Senior Manager... ...Data Management will lead and contribute to data... ...data management documentation; provide oversight of... ...and infrastructure strategy, such as SOPs, data... ...using standardized medical terminology, including...DocumentSeniorMedicalFull timeTemporary workFlexible hours- ...Senior Director, Clinical Pharmacology Reporting to the SVP of Research... ...of the translational strategy, including... ...components of regulatory documents, scientific data and... ...governance meetings Lead or participate in cross... ...and document complex medical/clinical concepts in...DocumentSeniorMedicalWork at office3 days per week
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