Senior Regulatory CMC Writer for Biologics (Remote)
TG Therapeutics, Inc.
- Remote job
TG Therapeutics, Inc. is seeking an experienced Regulatory CMC consultant with BLA writing expertise to provide hands-on authoring and submission support for biologics. The role focuses on Module 3 and related Quality content, collaborating with cross-functional teams to deliver regulator-ready CMC narratives and respond to FDA requests, while maintaining rigorous document control and traceability. This remote engagement requires excellent scientific writing, strong regulatory knowledge of FDA #J-18808-Ljbffr TG Therapeutics, Inc.
$132k - $172k
...for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing... ...lifecycle management activities for biologic products, with a strong focus on late... ...Diego. No role is expected to be 100% remote.Total Rewards Offerings:Travere...Remote workSeniorRegulatoryFull timeTemporary workWorldwide- ...approach to complex trial data and regulatory submission challenges. With a... .... This is a full-time, remote position. Roles and Responsibilities... ..., regulatory operations, and CMC. Demonstrated ability to... ...in pharmacology, toxicology, biology or chemistry, or related field...Remote workSeniorRegulatoryFull time
$55 - $75 per hour
...genetics and molecular biology, we develop medicines... ...is a Contract role- Remote can live anywhere in... ...55 to $75hour The Senior Medical Writer applies advanced documentation... ...study results for regulatory submissions and... ...nonclinical development, CMC, PK, PD, and antibody...Remote workSeniorRegulatoryFull timeContract workFor contractorsWorldwideShift work- ...Summarized Purpose: Provides high-quality regulatory medical and scientific writing in... ...development of pharmaceutical and biologic products, from planning and coordination... ...Reviews documents prepared by junior writers and peers. May provide training and...Remote workSeniorRegulatoryContract work
- ...Clinical Regulatory Document Specialist Company Overview Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device... ...within the medical/biomedical industry. BS or MS degree in biological science, epidemiology, engineering, statistics, or other science...Remote workSeniorRegulatoryInterim roleWorldwide
$72 - $81 per hour
...organization in the pharmaceutical and biologic development industry, is seeking a Senior Medical Writer to join their team. As a Sr.... ..., you will be part of the Regulatory Affairs department supporting clinical... ...Writer Location: 100% Remote (East coast preferred) Pay...Remote workSeniorRegulatoryWeekly payContract workTemporary workFlexible hours- ...DirectorJob Description - CMC Team Leader, Sr.... ...Technical OperationsLocation: [Remote]Department: Technical... ...and commercial-stage biologic products. This individual... ..., Quality, Regulatory Affairs, Supply Chain,... ...and recommendations to senior leadership in a concise...Remote workSeniorRegulatory
- ...With deep domain expertise in regulatory sciences, clinical research... ...mentors less experienced medical writers, as necessary. ~... ...regulatory documents for drugs, biologics, and/or medical devices/diagnostics... ...Whilst ProPharma supports remote working, we also recognise...Remote workSeniorRegulatoryContract workWork at office
- ...Excellent employment opportunity for a Analytical SME & CMC Technical Writer in the Ridgefield, CT area. (Remote) We are seeking an experienced Analytical... ...capabilities to support documentation and global regulatory submissions (e.g., IND, CTA, NDA/MAA). The successful...Remote workRegulatoryContract workWork experience placement
$132k - $172k
...for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing... ...support for combination products or biologic products when applicable; prior biologics... .... No role is expected to be 100% remote.Total Rewards Offerings:Travere provides...Remote workSeniorRegulatoryFull timeTemporary work- ...Full time Fully Remote Must be authorized to work in... ...the Role We're seeking a Senior or Principal Medical Writer to join our collaborative,... ...a lead writer on complex regulatory and clinical documents, provide... ...drug application (NDA)/biologic license application (BLA)...Remote workSeniorRegulatoryFull timeLive inWork at officeFlexible hours
- ## Job Details: Senior Manager, Medical/Regulatory WriterFull details of the job.| | ||... ...Manager, Medical/Regulatory Writer || | VN831 || | Full Time... ..., MD, Radnor, PA, Remote, US || | Regulatory Affairs... ...industry (preferably with biologics), experience in the preparation...Remote workSeniorRegulatoryFull timeContract work
- ...Therapeutics in Cambridge, MA, is seeking a Director of CMC Project Management to oversee end-to-end CMC execution for biologics, aligning process development, manufacturing, supply chain, quality, and regulatory functions. This senior role leads integrated CMC plans, manages...Remote jobRegulatory
- ...Therapeutics, Inc. in Cambridge, MA seeks a Director of CMC Project Management to lead end-to-end CMC programs for biologics in a lean biotech setting. You will own... ...development, manufacturing, quality and regulatory work. The role requires strong communication with...Remote jobRegulatory
- ...clinical-stage biotech company, seeks a Director of CMC Project Management to lead end-to-end CMC program execution for biologics. You will partner with the CMC Lead to align... ..., manufacturing, supply chain, quality, and regulatory functions. The role emphasizes tight...Remote jobRegulatory
- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from development through lifecycle management for biotechnology and pharmaceutical clients. The role focuses on leading global CMC activities, client liaison, and...Remote jobSeniorRegulatory
- Marea Therapeutics in South San Francisco is seeking a Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to lead regulatory strategies for manufacturing products in the US and globally. The role reports to the Executive Director, Regulatory Affairs...SeniorRegulatoryFull time
- Syneos Health is seeking a Senior Medical Writer Publications to lead the creation of medical writing... ...for sponsor-dedicated programs in a remote-based role. The candidate will manage... ...with cross-functional teams to ensure regulatory alignment and on-time delivery. The role...Remote workSeniorRegulatory
- ...Syneos Health is seeking a Sr Medical Writer Publications - Sponsor Dedicated for a remote-based role supporting publication deliverables for sponsor-driven... .... You will mentor junior writers, ensure regulatory compliance with ICH E3, manage timelines and budgets...Remote workSeniorRegulatory
- MMS Holdings Inc is seeking an experienced Medical Writer located in Bridgeport, Connecticut, to support the pharmaceutical and biotech... ...development documents and requires a strong background in regulatory writing alongside exceptional writing and organizational skills...Remote workSeniorRegulatory
- ...Syneos Health is seeking a Senior Medical Writer Publications for sponsor-dedicated work, primarily remote-based, to drive high-quality medical writing deliverables across... ...development, coordinate with clinical, regulatory, and biostatistics teams, ensure compliance...Remote workSeniorRegulatory
- ...Stryker is hiring a Senior Staff Medical Writer for the Endoscopy Division, remotely anywhere in the United States. The role focuses on developing regulatory and clinical documentation to support global registrations and lifecycle management, partnering with Regulatory...Remote workSeniorRegulatory
- ...Syneos Health, Inc. is seeking a Senior Medical Writer for Early Phase (Single Sponsor Support). This remote role spans multiple regulatory documents and collaborations across departments to deliver compliant submissions. The candidate should have strong EMA/FDA/ICH knowledge...Remote workSeniorRegulatory
- ...MMS Holdings Inc is looking for a Medical Writer with a focus on clinical development documents. The ideal candidate has 3-5 years of regulatory writing experience within the pharmaceutical industry and an advanced degree in a relevant discipline. You will be responsible...Remote workSeniorRegulatory
$55 - $75 per hour
A leader in biotechnology is seeking a Senior Medical Writer to draft and manage clinical documentation. This remote contract position offers a competitive hourly rate... ...writing skills, and a deep understanding of regulatory requirements. This role is crucial in supporting...Remote workSeniorRegulatoryHourly payContract work$120k - $200k
...and communities.The RoleFalcon Writer is Veeva's AI authoring... ...directly with medical writing, regulatory, and clinical teams at customer... ...customer discovery and align senior stakeholders and cross-functional... ...bonus and/or stock bonus.#LI-Remote#LI-MidSeniorVeeva’s headquarters...Remote workSeniorRegulatoryWork at officeLocal areaWork from home3 days per week$150k - $170k
...a talented, motivated Senior Manager to join our Portfolio... ...Technology, Clinical, Regulatory, and other development... ...with an emphasis on CMC knowledge and the ability... ...(US-based, west coast remote may be considered for... ...preferred; experience with biologics or complex modalities...Remote workSeniorRegulatoryFull timeWork at officeLocal area- ...Stryker is hiring a Senior Staff Medical Writer to join the Endoscopy Division. This remote role supports the US market for regulatory and scientific documentation throughout the product lifecycle. Based in the United States, you will author CERs, PMCF, and other clinical...Remote workSeniorRegulatory
- ...Stryker is hiring a Senior Staff Medical Writer for its Endoscopy Division. This remote, nationwide role focuses on developing regulatory and scientific documents to support global registrations and lifecycle management of medical devices. You will translate complex...Remote workSeniorRegulatory
- ...Syneos Health seeks a Sr Medical Writer for sponsor-dedicated projects, remotely based. The role leads the production of manuscripts, abstracts, posters... ...presentations, coordinating across departments and ensuring regulatory and client standards are met on time and on budget....Remote workSeniorRegulatory
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