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
$119.7k - $222.3k
...Sciences representative to lead the development and... ...(AI) enabled strategies to transform clinical pharmacology support... ...authoring regulatory documents.This role reports to... ...to be considered for Senior Principal Scientist.... .... If, because of a medical condition or disability...DocumentSeniorMedicalFull time- ...Responsibilities The Contract Sr. Clinical Scientist will ideally... ...and communicate strategy proposals well-... ...literature. *Collaborates with medical writing to author clinically... ...and/or reviews documents related to trials, such... ...with minimal support *Leads planning and prepares...DocumentSeniorMedicalContract work
$105.8k - $175k
...We are seeking a Senior Environmental Permitting Lead to drive the successful... ...permitting strategy, regulatory interface... ...control of environmental documents, technical analyses... .... Strong technical writing, editing, and... ...Employees have access to medical, dental, vision,...DocumentSeniorMedicalFull timeLocal areaRemote workShift 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$268k - $302k
...Senior Director, Clinical PharmacologyCambridge, MA - RemoteAmylyx... ...clinical pharmacology strategies that support... ...Medicine, Nonclinical, Medical Writing, and external partners... ...will independently lead assigned programs while... ...submission documents including INDs, briefing...DocumentSeniorMedicalLocal areaRemote work$232k - $348k
...DescriptionThe Regulatory Strategy Senior Director is a... ...Responsibilities:Leads the development... ...Strategy Documents including for regulatory... ...input into clinical programs and commercial... ...and in writing regulatory strategy... ...aspirations. From medical, dental and vision...DocumentSeniorMedicalFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- Treeline Biosciences is seeking an Associate Director / Director, Medical Writing in Oncology to author and coordinate high-quality regulatory and clinical documents across the product lifecycle. You will own documents end-to-end and coordinate with Regulatory, Clinical...DocumentSeniorMedical
$210.9k - $379.2k
...oncology drug developer lead Clinical Development for one or... ...and will have direct medical responsibility for... ...designing clinical studies, writing protocols, ensuring... ...Leadership, Direction and Strategy: Employs visioning and... ...) including briefing documents, presentations,...DocumentSeniorMedicalPermanent employmentFull timeWork at officeWork from home$225k - $275k
Senior Director, Global Regulatory Strategy Centessa Pharmaceuticals, a wholly owned... ...and Company, is a clinical-stage company... ...disorders. Centessa’s lead investigational... ...VP, Regulatory and Medical Writing and serve as a key... ..., NDAs, briefing documents, and other regulatory...DocumentSeniorMedicalFull time$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$107.1k - $113.9k
...Overview The Lead Senior Science Writer plays a crucial... ...other Harvard Medical School-affiliated hospitals... ...papers, results from clinical trials, and content from... ...internal tracking systems to document information pertaining... ..., and more. • Writing and Editing: Plan and...DocumentSeniorMedicalRemote workAfternoon shift$228.8k - $343.2k
...opportunity to join the team as our Senior Director, Clinical Sciences. This is a hands-... ...Development.Your Role:Lead, mentor, and develop a... ...Medicine, and Medical Writing to ensure high-quality execution... ...and review of key clinical documents, including protocols, investigator...DocumentSeniorMedical$210.9k - $379.2k
...oncology drug developer lead Clinical Development for one or... ...and will have direct medical responsibility for... ...designing clinical studies, writing protocols, ensuring... ...Leadership, Direction And Strategy Employs visioning and... ...) including briefing documents, presentations,...DocumentSeniorMedicalPermanent employmentWork at officeWork 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 Clinical Research Associate (Level II) As... ...records review. Documents observations in... ...approved business writing standards.... ...discusses potential strategies for their management... ...newsletter creation, lead CRA team calls... ...to evaluate medical research data and...DocumentSeniorMedicalWork at officeRemote workRelocationHome officeRelocation packageFlexible hoursNight shift
$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... ...and maintain study documents, including protocols...DocumentSeniorMedicalTraineeshipRemote workShift work- Senior Director, Program Leader, Corporate Strategy At Agios, we are fueled by connections... ...for a critical clinical stage program. You... ...mitigation strategies. Lead asset... ...Ensure key program documents reflect full cross... ...Collaborate with Medical Affairs and Clinical...DocumentSeniorMedical3 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
- ...drive groundbreaking medical discoveries and... ...budgetary, grant writing, communication, and... ...detailed protocol documents that meet federal... ...compatibility with clinical practices. -Provides... ...if applicable)The Senior Clinical Research... ...data management; lead a team of clinical...DocumentSeniorMedicalFull timeContract workRemote work
- ...DescriptionAECOM is seeking a Senior Rail Systems Lead to join our World Class... ...specifications, procurement documents, design and installation packages... ...skills, and report writing skillsAdditional InformationSponsorship... ...AECOM benefits may include medical, dental, vision, life, AD&D...DocumentSeniorMedicalWork at officeLocal areaWorldwideRelocationFlexible hours
- 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
$310.9k
...Development Team (PDT) lead has primary... ...directing of clinical research... ...development of program strategy and design,... ...Directors and/or Senior Clinical... ...detailed development documents, presentations,... ...communication verbally, in writing, and during... ...include medical, dental, vision...DocumentMedicalFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$296k - $355k
...Senior Medical Director, Clinical Development Waltham, Massachusetts At Kailera, we are bold, authentic... ...execution of clinical development strategies across multiple studies Acts as... ...including protocol and regulatory document writing Demonstrated ability to engage with...DocumentSeniorMedicalFull timeLocal areaFlexible hours3 days per week- Hemab Therapeutics seeks a leader to own end-to-end medical strategy for one or more Hemab assets, guiding evidence planning, publication strategy... ..., and market-facing narratives. You will collaborate across Clinical Development, Regulatory, and Medical Affairs to translate...SeniorMedical
$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$130k - $160k
...Summary: We are seeking a Senior Clinical Trial Manager with... ...Clinical Operations members to lead the clinical project... ...selection. Contribute to the writing and/or review of clinical documents such as Protocols,... ...documents. Liaise with medical monitor and cross functional...DocumentSeniorMedicalContract workLocal area$237.2k - $372.79k
...Join us as a Global Medical Lead, Dermatology in... ...the medical strategy and execution of... ...dermatology late-phase clinical studies in global... ...Team (GPT), senior leadership in Global... ...roles in developing documents required to... ...in study designs, writing protocols, analysis...DocumentMedicalMinimum wageTemporary workWork at officeLocal areaRemote workWeekend work$274.4k - $411.6k
...Massachusetts.Summary The Senior Director, Clinical Development will provide medical and scientific... ...programs, driving clinical strategy from early-stage development... ..., this individual will lead cross-functional... ...and other key clinical documents in compliance with project...DocumentSeniorMedical- ...Senior Medical Director, Clinical Development A growing biopharmaceutical organization... ...Development to help shape clinical strategy and advance innovative... ...the SVP of R&D, you will lead clinical planning, trial... .... Develop key clinical documents (protocols, SAPs, CSRs). Analyze...DocumentSeniorMedical
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