Senior Regulatory Writing Lead (Remote)
Daiichi Sankyo, Inc.
Daiichi Sankyo, a global healthcare leader, seeks an Associate Director, Regulatory Writing to produce high-quality regulatory documents and meet strict timelines. This role collaborates across functions and focuses on BLA/MAA submissions, CSRs, and briefing books while managing information flow and strategy. The candidate will contribute scientific insights, oversee complex documents, and guide study teams on regulatory expectations, ICH guidelines, and filing readiness within a dynamic #J-18808-Ljbffr
- ...global footprint, the full-time Senior Compliance Lead will perform sanctions... ...streamline processes in a fully remote environment. Key... ...circumvention risk and prepare regulatory reports as needed Coordinate... ...UN programmes Experience writing sanctions reviews or investigation...Remote workSeniorRegulatoryFull time
$160.8k - $201k
...seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high quality clinical and regulatory documents. You will lead MW strategy, coordinate across cross-... ...environment. The role is fully remote in the United States, with a salary range...Remote workSeniorRegulatory- ...United Biosource Corporation is seeking a Sr. Manager of Medical Writing to lead a team of medical writers and to oversee the creation of regulatory and educational documents for client projects. You will translate complex medical concepts for diverse audiences and ensure...Remote workSeniorRegulatory
- ...United States is seeking a Sr. PSUR Writer to lead the development, review, and submission... ...-market surveillance documentation and regulatory requirements, with a focus on safety... ...compliance with domestic and international regulations in a remote-work #J-18808-Ljbffr...Remote workSeniorRegulatory
- ...Commercial LLC is seeking a Sr Medical Writer Publications to lead the completion of medical writing deliverables remotely. This role involves managing writing activities, ensuring adherence to regulatory standards, and mentoring junior writers. The ideal candidate will...Remote workSeniorRegulatory
- ...Syneos Health is seeking a Senior Medical Writer Publications - Sponsor Dedicated - Remote Based to lead and manage medical writing deliverables across studies. You will ensure accuracy, maintain regulatory compliance, and mentor junior writers while coordinating with...Remote workSeniorRegulatory
- ...INC Research is seeking a Senior Medical Writer to support clinical study and regulatory project teams. This position is home based anywhere in the US. The ideal... ...mentor junior writers while managing complex medical writing tasks across various therapeutic areas. The role...Remote workSeniorRegulatoryWork from home
- ...experienced Medical Writer to join a remote, globally oriented team. You... ...evaluate literature, write clinical protocols and study reports... ..., and ensure high-quality regulatory submissions. The role emphasizes... ...skills, and proven ability to lead project teams under aggressive...Remote workSeniorRegulatory
- ...Princeton10, LLP seeks a Senior Medical Editor to lead editorial quality and regulatory compliance across promotional content. You will report to the Manager, Editorial... ...content from draft to final approval. This remote-friendly role in the United States or Canada...Remote workSeniorRegulatory
- ...Parexel is seeking a Medical Writer in the United States to author and revise clinical documents for regulatory submissions. The role requires strong writing/editing skills, adherence to regulatory guidelines, and collaboration with cross-functional teams on project timelines...Remote workSeniorRegulatory
- ...TransPerfect is seeking an organized medical writer to lead planning and preparation of high-quality regulatory documents for clinical development. You will... ...module documents within timelines. The role is fully remote in the United States with on-site meetings as...Remote workSeniorRegulatory
- ...organization, seeks a Medical Writer to craft regulatory and clinical development documents.... ...have 3–5 years of regulatory writing experience, strong writing skills, and a track record leading authoring projects under tight deadlines. Remote work is available for Brazil-based...Remote workSeniorRegulatory
- ...their merit. Job Function: Regulatory Affairs Group Job Sub... ...All Job Posting Locations: Remote (US), Santa Clara, California... ...the best talent for a Senior Regulatory Affairs Program Lead to support our OTTAVA... ..., including preparation, writing and filing of FDA submissions...Remote workSeniorRegulatoryFlexible hours
- ...sk - Jobboard is looking for a Senior Medical Writer to work remotely in Rockford, IL. The role requires a strong background in regulatory and clinical medical writing, with at least 3-5 years of experience... ...in project management and leading project teams. Join us to...Remote workSeniorRegulatory
- ...Environmental Consultants is seeking a Lead, Senior, or Principal Biologist with... ...be worked in a hybrid or remote capacity from most locations... ...alignment with industry and regulatory standards. Serves as a go-to... ...and strategy, and excellent writing skills required.Experience...Remote workSeniorRegulatoryFull timeFor contractorsFor subcontractorWork at officeLocal area
- Angitia Biopharmaceuticals seeks a Sr. Manager/Associate Director, Regulatory Writing, to lead writing across its development programs from IND through lifecycle management. You will plan, author, coordinate, and deliver submission-ready documents with strict timelines...Remote jobSeniorRegulatory
$123.4k - $224.2k
...impact We are seeking a Senior NEPA Environmental Lead to support and help grow our... ...environmental strategy, regulatory interface, and high-quality... ...interviews.Strong technical writing, editing, and... ...Jacobs offices/projects and remote locations enabling them to...Remote workSeniorRegulatoryFull timeWork at officeLocal areaWork from home$110k - $160.91k
...This role is focused on leading and overseeing routing... ...engagement, and regulatory documentation and state... ...Transmission Line Siting Senior Lead, you will serve as... ..., hybrid, or fully remote based on your location... ...Exceptional technical writing, communication, and organizational...Remote workSeniorRegulatoryFull timeFixed term contractCasual workWork at officeFlexible hoursShift work- ...Commercial LLC is looking for a Sr Medical Writer Publications to lead the completion of medical writing deliverables. This remote-based role requires deep expertise in medical writing, ensuring compliance with regulatory standards, and mentoring less experienced team members....Remote workSeniorRegulatoryFlexible hours
$105.8k - $175k
...impact We are seeking a Senior Environmental Permitting Lead to drive the successful planning... ...permitting strategy, regulatory interface, and high-... ...departments. Strong technical writing, editing, and... ...Jacobs offices/projects and remote locations enabling them to...Remote workSeniorRegulatoryFull timeLocal areaShift work$109k - $174.8k
...merit. Job Function: Regulatory Affairs Group Job Sub... ...United States of America, Remote (US) Job Description:... ...for the best talent for a Senior Regulatory Affairs Program Lead to support our Wound Closure... ..., including preparation, writing and filing of FDA...Remote workSeniorRegulatoryLocal areaImmediate start- ...seeking an experienced Senior IT Systems Solutions Architect... .../ Cybersecurity RMF Lead to support a... ...Excellent technical writing, communication, and stakeholder... ...required by the Government. Remote or hybrid arrangements... ..., and maintain regulatory compliance. Cybersecurity...Remote workSeniorRegulatoryContract workFor contractors
$160k - $200k
...Equity Research publications team. This role requires seasoned writing, editing and regulatory oversight to ensure accuracy and compliance across reports and marketing decks. The position offers hybrid or remote work, with standard evening hours and occasional peak-period...Remote workSeniorRegulatoryAfternoon shift$72.6k - $145.2k
...function sits at the intersection of regulatory accountability and technology,... ...for a Sr. Compliance Associate Lead, Sanctions Operations to join us fully remote. This role reports directly to Kraken... ...UN programmes. ~ Experience writing sanctions reviews or investigation...Remote workSeniorRegulatoryFull timeLocal area- ICF seeks an experienced Senior Archaeologist for Northern California,... ...with potential for full or partial remote work. The position spans... ...management with fieldwork and report writing. This role supports CEQA, NEPA, and NHPA regulatory compliance on Transportation, Water...Remote jobSeniorRegulatory
- Synterex, Inc. is seeking a Senior Medical Writer to join their team remotely. This role involves leading the planning and preparation of clinical regulatory documents while collaborating with various... ...5 years of experience in medical writing within the CRO/biotech industry....Remote jobSeniorRegulatory
$121k - $185k
...and compliance story. As our Senior GRC Security Lead, you will be the architect... ...aligned with evolving regulatory requirements, industry frameworks... ...policy and standards writing ability — capable of translating... ...to help you succeed in a remote environment. The annual...Remote workSeniorRegulatoryFull timeWork from homeFlexible hours- Syneos Health/ inVentiv Health Commercial LLC is seeking a Senior Medical Writer to lead and manage medical writing deliverables. This remote-based role involves ensuring scientific clarity and adhering to regulatory standards in documents such as journal manuscripts and...Remote jobSeniorRegulatoryFlexible hours
- ...for the Cultural Resources Lead - Senior Archaeologist role at Freese... ...research, technical report writing, state and federal archaeological... ...and federal environmental regulatory framework, including the... ...schedule with up to 40% of remote work, and an alternative work...Remote workSeniorRegulatoryFull timeWork at officeLocal areaImmediate startFlexible hours
- ...Publications - Sponsor Dedicated - Remote Based Syneos Health is a leading fully integrated biopharmaceutical... ...accurate completion of medical writing deliverables, ensuring scientific... ...meetings. Adheres to established regulatory standards, including, but not limited...Remote workSeniorRegulatoryContract workFlexible hours
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