Senior Medical Writing Lead - Clinical Documents & Strategy
Alnylam Pharmaceuticals
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 Pharmaceuticals
$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$95k - $115k
...seeking an experienced Senior Proposal Lead to join our... ...success through thoughtful strategy, strong project management... ...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- ...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
$179k - $236k
...Scientific Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical programs, operating as a hands... ...filings (e.g., IND) and briefing documents; support agency interactions... ...Strong scientific writing skills - regulatory documents...DocumentSenior$137k - $215.27k
...of the global clinical research programs... ...) and Global Medical Marketed Products... ...program audit strategy, ensuring communication... ...are in place. Leads the clinical... ...delivery, documents, databases, vendors... ...solutions to senior management for... ...Effective technical writing skills; able to...DocumentSeniorMedicalMinimum wageWork at officeLocal areaImmediate startNight shift$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$163.33k - $186.67k
...Korro Clinical Trial Leader Company Summary... ...background leading early phase clinical... ...clinical operational strategy for successful... ...of study documentation including protocol... ...source documents, and medical records. Evaluate... ...review, and report writing Oversee TMF...DocumentSeniorMedicalLocal areaFlexible hours$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$68.4k - $232.8k
...policies, codes of Good Clinical Practice (GCP),... ...assigned programs.Leads and contributes to... ...to study-level documents and independently... ...forecasting, and mitigation strategies for complex... ...in speaking and writing the country language... ...of innovative medical treatments to help...DocumentSeniorMedicalFull timePart timeLocal areaImmediate startWorldwideNight shift$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- 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
- ...Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program. You will develop key clinical documents in accordance with GCP, FDA...DocumentSeniorMedicalContract work
$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- 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
$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$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$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 package- ...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
- ...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
$126k - $234k
...Cambridge, MA We are Clinical Sciences and Innovation... ..., you will support or lead the clinical science and... ...and other required documents Ensure quality conduct... ...and protocol development/writing is highly desirable... ...disabilities. If, because of a medical condition or disability...DocumentSeniorMedicalWorldwide$153k - $197.6k
...Senior Clinical Trial Manager Watertown, Massachusetts, United... ...final study deliverables. Lead external (CRO) trial... ...monitoring, data management, medical monitoring, medical writing, statistics and safety/... ...operational input into study documents including clinical...DocumentSeniorMedicalFixed term contractWork at office- ...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
$100k - $125k
...Clinical Trial Manager We are seeking a Clinical... ...trial. Works with senior Clinical Operations members to lead the clinical project... ...Contribute to the writing and/or review of clinical documents such as Protocols, Informed... .... Liaise with medical monitor and cross...DocumentSeniorMedicalContract workLocal area- ...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
- A leading biotech company based in Cambridge, Massachusetts, is looking for a Principal Medical Writer to represent medical writing on multi-disciplinary teams. This role involves producing high-quality clinical documents, independently coordinating the development and...DocumentMedical
$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...DocumentSeniorMedicalFull timeLocal areaFlexible hours3 days per week$150.5k - $245.5k
...Regeneron seeks a Senior Manager, Clinical Scientist to lead ophthalmology clinical... ..., partnering with Medical Directors and cross... ...Lead scientific strategy for clinical studies... ...and review key trial documents including synopses,... ...~ Strong medical writing and clinical research...DocumentSeniorMedical$168k - $188k
...Senior Clinical Trial Manager (CTM) United States - Remote Senior Clinical Trial Manager... ...-related trackers such as regulatory documents, trial master file (TMF), startup... ...Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)...DocumentSeniorMedicalContract workLocal areaRemote workFlexible hours$94.9k - $115.4k
...Description \n The Lead Research... ..., chargeback, and clinical trial funding.\n... ...Faculty to help set strategy and provide guidance... ...including other Harvard Medical School-affiliated... ...experience with electronic document and email file... ..., both in writing and verbally \n...DocumentMedicalWork at office$206.25k - $297.92k
...Real World Evidence Strategy LeadLocation:... ...Evidence (RWE) Strategy Lead, you will... ...Areas, translating medical needs into evidence... ...intended purposes for clinical, or regulatory decision... ...communicated and documented consistently... ...teams as well as senior leaders through personal...DocumentMedicalFull timeLocal area
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