R&D Document Standards & Submissions Lead
Mass Digital Health
Mass Digital Health is looking for a Lead in R&D Document Standards & Integrated Services. You will drive operational excellence in document authoring and standardization across the R&D organization. This role emphasizes collaboration with global teams to enhance the document management process. The ideal candidate should have a Bachelor's degree, 8+ years of experience in regulatory operations, and proficiency in document management software. Join us in redefining the future of drug development with innovative processes and tools. #J-18808-Ljbffr Mass Digital Health
$148.5k - $214.5k
Job title: Lead, R&D Document Standards & Integrated Services Location: Morristown, NJ / Cambridge, MA About the job As Lead, R&D Document Standards... ...Services within our R&D team , you will be part of our Submission & Document Services Platform that supports critical...DocumentWork at office- ...regulatory operations with proficiency in eCTD submissions and vendor oversight. The candidate will... ..., maintain compliance with global standards, and prepare submission-ready documents. The position offers an opportunity to lead cross-functional teams and contribute to...Document
$136k - $170k
...processes. You will engage with stakeholders to streamline regulatory submissions and manage timelines effectively. The ideal candidate will... ...8 years of relevant experience, and expertise with Veeva and document management systems. A competitive salary ranging from $136,000...Document$150k - $200k
...biopharmaceutical company is seeking a Medical Writing Lead to oversee the creation of clinical documents across drug development stages. The successful... ...medical writing experience and expertise in regulatory submissions. This hybrid role allows employees to work from...Document- ...end of the decade. Our R&D focuses on discovering... ...Position Summary You will lead Chemistry,... ...expectations and global standards. Prepare and review technical regulatory documents for U.S. authorities, including... ...a focus on IND and BLA submissions to the FDA. Experience...DocumentLocal area
$150k - $200k
Medical Writing Lead, Global Clinical Operations,... ...delivery of clinical documents across all phases of drug... ...and global regulatory submissions, ensuring quality and... ...and maintain writing standards, templates, and best practices... ...the following Global R&D locations: Cambridge...DocumentWorldwide- Job Title: Modeling Lead Global HEVA (Health Economics... ...for local HTA submissions Conceptualize advanced... ...About Sanofi We’re an R&D‑driven, AI‑powered biopharma... ...manner and to high standards of quality and rigor... ...and use with payers Documented experience having initiated...DocumentLocal area
$212k - $333.19k
...‑looking, world‑class R&D organization that unlocks... ...Regulatory Platform Lead GRA CMC, Device and... ...regulations and guidance documents; and acts as an... ...regulatory requirements and standards Proactively identifies... ...of global regulatory submissions (e.g., Core Dossiers,...DocumentFull timeTemporary workLocal areaWorldwideNight shift$53.45 - $68.16 per hour
...routine situations and may be responsible for leading daily operations, and trains, delegates... ...procedures that follow radiological standards in a safe, accurate and timely manner,... ...examinations, observe patients, read monitors and documents, and hear audible equipment alarms. 4...DocumentWork experience placementRelocation packageAll shifts- Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge... ...bold, AI-powered research. In R&D, you’ll drive breakthroughs... ...Strategy (GRPS), Global Submission Strategy, and core product labeling... ...Authority meeting briefing documents and negotiating with a national...Document
- Responsibilities Lead and manage publishing activities for IND, NDA, ANDA... ..., Safety Reports, and Promotional Submissions. Oversee submission-level and document-level publishing including metadata... ...training sessions on publishing standards and processes. Handle client communication...Document
$137k - $215.27k
...Plasma-Derived Therapies (PDT) R&D Organization is dedicated to... .... As Manager Regulatory Lead you will be accountable for recommending... .... Liaise with the US FDA on submissions within the role’s... ...the collection of regulatory documentation for new registrations and license...DocumentOdd jobTemporary workLocal areaFlexible hours- ...collaborating with Biostatistics, and implementing data strategy standards. The ideal candidate should have strong experience in SAS... ...programming, a background in clinical trials, and knowledge of drug submission guidelines. This hybrid role offers a competitive salary and a...
$184.11k - $216.6k
Foundation Medicine is seeking an IT leader in Boston, MA to bridge R&D, Product, and IT. The role focuses on strategic initiatives,... ...technology experience, with an advanced understanding of industry standards and data governance principles. A competitive salary range of $1...$145k - $195k
...assurance professional to manage vendor qualifications and oversee R&D compliance for clinical studies. The role includes auditing... ...operations, supporting clinical oversight, and ensuring adherence to GCP standards. Ideal candidates will have 8-10 years of experience in biotech...Full time$145.35k - $253.23k
...opportunities, a world-class training facility, and leading market tools, we help our people... ...and Controlling. Drive fit to standard workshops, design decisions, and configuration... ...EPPM functionality with clearly documented gaps and extensions where required. Deliver...DocumentFull timeH1bLocal area$130k - $150k
...Medicines, Inc. is seeking a talented Medical Writer to oversee documents for clinical development programs. This role requires at least... ...’s degree in a scientific discipline. Responsibilities include leading the preparation of clinical trial documents and collaborating with...DocumentRemote jobFlexible hours$116k - $145k
The Importance of the Role Lead Data Manager, Clinical Data Management... ...‑quality data with proper documentation and inspection readiness.... ...DM perspective, regulatory submission activities for assigned... ...development of cross‑functional standards and processes. Review and...DocumentWork at office$133k - $285k
...industry to build, grow, and lead the delivery of client engagements... ...how they operate across R&D, clinical development, and adjacent... ...establishing delivery standards, developing offerings, growing... ...transformation point‑of‑view documents tailored to life sciences use...DocumentStart working todayLocal areaRemote work- ...seeking an experienced professional to lead CMC analytical development as Aerska advances... ...methods at CDMOsto support IND/CTA submissions in line with ICH guidelines and regulatory... ...packages and CMC sections to regulatory documents including IND/IMPDs, pre-IND briefing...Document
$169.4k - $266.2k
...Scientific Communications Group Lead, Solid Tumors. As a subject... ...slide decks, NCCN or pathway submissions, animations, and digital... ...ensuring compliance with global standards, and for ensuring accuracy and... ...that this foundational document, which is centered on core scientific...DocumentMinimum wageFull timeFor contractorsWork experience placementFreelanceLocal areaRemote work$147k - $212k
...Job Title: GRA Device Lead (Associate Director)... ...Department within Global R&D. The GRA Device organization... ...-quality regulatory submissions, managing compliance,... ...environment and updating of standards and processes related... ..., communication and document management. Contribute...DocumentTemporary workLocal areaWorldwideFlexible hours- ...Lead Architect Connolly Brothers is seeking a design-driven Lead Architect to serve... ...conceptual design through construction documentation and construction administration Develop... ...codes, zoning regulations, and industry standards Review and contribute to construction...DocumentFull timeWork at office
- ...RESPONSIBILITIES The Front Desk Weekend Lead (Part-Time) position provides a... ...yourself and the SSR team accountable to high standards of operational excellence. Assist in... .... Review and adhere to all NYSC documents including but not limited to policies and...Document16 hoursTemporary workPart timeLocal areaShift workWeekend work2 days per week
$39.5 - $54 per hour
...order to deliver quality patient care Perform and document preventive maintenance and quality control procedures... ...certifications ~6 months or more of supervising or leading a team Additional Job Standards In lieu of education requirements listed above,...DocumentHourly payTemporary workCasual workMonday to FridayFlexible hoursShift work$160k - $241k
...Clinical Trial Leader (CTL) to lead cross-functional clinical... ...regulatory requirements, and internal standards. This individual will play a... ...and review of key study documents (e.g., ICFs, CRFs, monitoring... ...Contribute to regulatory submissions and responses as needed....DocumentInterim role$100k
...Maximus is seeking a Certification Lead to manage end-to-end certification activities... ...and adhere to life cycle work patterns, standards, and procedures for systems development.... ...deployment. Assist in providing system documentation to include functional specifications,...DocumentRemote work$22.62 - $28.55 per hour
...patient care by maintaining the highest standards of instrument processing and infection control... .... Conduct routine safety checks and document maintenance activities. Quality... ...Collaborate with Medical Assistant floor leads to maintain adequate par levels of instruments...DocumentFull timeShift workWeekend workAfternoon shift- ...Periodic Reporting Manager in Cambridge, MA to oversee periodic reporting initiatives, ensuring compliance with timely submissions of critical regulatory documents. You will leverage strong analytical and collaboration skills to optimize reporting processes in a dynamic...Document
- ...for an Associate Director, Medical Writing Science to manage document development for regulatory filings. This hybrid position allows... ...leadership in managing a team, have a strong background in regulatory submissions, and possess a Ph.D. with 8+ years of experience. #J-18808-...DocumentRemote jobWork at officeRelocation package
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