Strategic Lead, Clinical Regulatory Writing
AstraZeneca GmbH
AstraZeneca GmbH is looking for an Associate Director in Clinical Regulatory Writing based in Gaithersburg, Maryland. This role involves leading the regulatory writing activities for drug projects, ensuring compliance with technical and regulatory standards. The ideal candidate will have significant experience in medical writing, a Bachelor's in Life Sciences, and strong communication project leadership skills. The position offers competitive compensation and various benefits, including health coverage and retirement programs. #J-18808-Ljbffr AstraZeneca GmbH
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Strategic Lead, Clinical Regulatory Writing in Gaithersburg, MD vacancy
- AstraZeneca in the United States is seeking an Associate Director, R&I Clinical Regulatory Writing (CReW) to lead strategic clinical-regulatory communications within delivery or submission teams. The role focuses on high-quality document creation and advocacy for best...Regulatory
- ...LifeScience in Gaithersburg, Maryland, is looking for a Clinical Regulatory Writing Associate Director. This role involves... ...Sciences Master's degree. The Associate Director will lead authoring teams, provide strategic leadership on projects, and support the development...Regulatory
- The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align... .... Our vision is to be an industry leading organization driving strategic...Regulatory
- ...recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical... ...team, the Associate Director provides strategic communications leadership to projects... ...clinical Submission Communication Strategy. Lead internal/external authoring teams and...RegulatoryHourly payContract workTemporary work
AstraZeneca
Gaithersburg, MD20 hours ago $136.78k - $205.18k
...Associate Director, Clinical Regulatory Writing (CReW) We are recruiting an Associate Director, Clinical... ...to drug projects and authors strategically important clinical‑regulatory documents... ...efficiency. When acting as a submission lead, drive the development of the clinical...RegulatoryHourly payTemporary workAstraZeneca
Gaithersburg, MD4 days ago- AstraZeneca in Gaithersburg, MD seeks an Associate Director of Clinical Regulatory Writing to lead regulatory writing activities across a portfolio, author key documents, and drive strategic communications for submissions. Ideal candidates have 5+ years of medical writing...Regulatory
$221.7k - $354.7k
...The Department Lead Scientific Communications... ...writers dedicated to early clinical publications and a... ...dissemination, publications and strategic scientific narrative... ..., Medical Affairs, Regulatory, Commercial) to ensure... ...and leads the medical writing team responsible for...RegulatoryFreelanceWorldwide- ...in Rockville, MD is seeking an experienced Proposal Content Lead to develop strategic proposal content. You will play a vital role in... ...to your success in this role. This position requires strong writing skills and a background in proposal development, particularly...
$136.78k - $205.18k
...recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical... ...team, the Associate Director provides strategic communications leadership to projects... ...Submission Communication Strategy. ~ Lead internal/external authoring teams and...RegulatoryHourly payContract workTemporary work$55k - $60k
About Us CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early... ...Must be able to effectively communicate verbally and in writing. Minimum high school diploma or GED. 3 years of mental health...Full timeWork at officeFlexible hours$21 - $24 per hour
...additional pricing tasks related to local regulations and/or regulatory compliance programs are completed accurately and within the required... ...retail key holder work experience. Must be fluent in reading, writing, and speaking English. (Except in Puerto Rico) Preferred...RegulatoryHourly payWork experience placementSeasonal workLocal areaShift workWalgreens
Germantown, MD2 days ago- Sonara Inc. is looking for a Regulatory Writing Expert in Rockville, MD to support federal rule development and revision. This role requires strong regulatory experience and excellent communication skills. As a key player, you will draft proposals and responses for federal...RegulatoryRemote jobFull time
- A clinical research organization is seeking an Ophthalmology Strategy and Medical Monitor. This role involves strategic medical leadership and oversight of ophthalmology trials, focusing on... ...with experts, and supporting regulatory processes. Competitive benefits include...RegulatoryRemote workFlexible hours
EMMES Corporation
Rockville, MD1 day ago - ...Senior Medical Director, Global Clinical Development (Infectious... ...internal governance meetings Lead the Clinical Team and work closely... ...Patient Safety, Biometrics, Regulatory Affairs, and Clinical... ...Adverse Events and review and writing of safety narrative reports...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week
$26 - $27 per hour
...USA Description About Us: CenExel is a leading nationwide clinical research site and patient network... ...compliance. Performs administrative and regulatory duties related to the study as... ...effectively communicate verbally and in writing. Working Conditions Indoor, Office environment...RegulatoryFull timeWork at officeShift workNight shiftCBH Health
Gaithersburg, MD8 hours ago$55k - $65k
...Clinical Research Coordinator I Rockville-Shady Grove - Rockville, MD 20850 Start Date... ...EDC efficient and accurately Maintain regulatory documents related to ISF Follow SOPs,... ...in English, both verbally and in writing, with proper grammar and spelling skills...RegulatoryFull timeContract work- ...Hiring: IT Business Partner – Clinical Trials / Biopharma IT (C2C... ...supporting clinical systems, regulatory environments, or pharmaceutical... ...IT experience to serve as the strategic liaison between IT and... ...Regulatory Affairs, Medical Writing, and Quality. This role is...RegulatoryContract workFor contractorsVisa sponsorship2 days per week1 day per week
- JobRx, Inc. is seeking a Regulatory Affairs Manager (RAM) based in Gaithersburg, Maryland, to lead the end-to-end planning and execution of regulatory deliverables. The... ...key role in regulatory submissions, providing strategic insights and managing regulatory applications....Regulatory
$210.4k - $331.1k
Overview The Regulatory Affairs Headquarters Principal... ...Regulatory Affairs and Clinical Safety - Vaccine & Infectious... ...of drug development. Leads cross-functional... ...interactions and provide strategic direction across... ...Disease Leadership Medical Writing Pharmaceutical...RegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$249.83k - $374.74k
...Translational Sciences and Clinical Development (TSCD) team, we... ...clinical study design as well writing protocols, key study and... ...advocacy groups. ~ Medical Lead for regulatory communication and... ...available, provide clinical strategic input to in-licensing opportunities...RegulatoryTemporary workWork at officeFlexible hours3 days per week$130k - $160k
...fragmented, multi‑site clinical and omics datasets... ...Quality & Compliance Lead to build and own the validation... ...are high, and the regulatory landscape is evolving... ...scientific publications, and strategic enough to build a... ...team — contributing writing, editing, and structuring...RegulatoryTemporary work$113.85k - $189.75k
Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects for vaccines. You will manage CMC... ...teams including quality, manufacturing and clinical development. Strong written and verbal communication...RegulatoryLocal area$133.13k - $221.88k
...oversee all aspects of chemistry initiatives, direct a team of professionals, and ensure compliance with regulatory standards. Key responsibilities include developing strategic visions, collaborating with engineers, and managing budgets. With a required Bachelor’s degree and...RegulatoryFull time- ..., investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents... ...planning, including development of strategic medical communication plans... ...project delivery Ensures that medical writing deliverables conform to the...Regulatory
Cedent
Rockville, MD1 day ago - ...MD is seeking an experienced Intake & Admissions Manager to lead the clinical and administrative operations of the Intake and Admissions team... ..., manage staffing, and maintain EMR documentation and regulatory compliance while coordinating with referral sources and community...Regulatory
$242.55k - $404.25k
...leadership role at the forefront of clinical delivery representing development Operations... .... As Senior Clinical Operations Lead, you will hold strategic accountability for highly complex... ...recruitment models, accelerated regulatory pathways and patient advocacy group...RegulatoryContract workLocal areaImmediate start$147k - $226k
...facilities. We are looking for a dedicated Lead Architect to join our talented team at... ...staff to assure compliance with legal, regulatory, and IPS project requirements.... ..., Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management...RegulatoryFor contractorsWork at officeFlexible hoursIPS-Integrated Project Services, LLC
Germantown, MD3 days ago- ...Canyon Consulting (BCC) is searching for a Clinical Trials Coordinator to support our work... ..., audits, and required reporting to regulatory bodies and intramural research programs... ...Contribute to scientific and technical writing including documentation, checklists, and...RegulatoryPart timeWork at officeRemote work
Black Canyon Consulting LLC
Bethesda, MD4 days ago - ...Clinical Project Manager (Quality Systems) Bethesda, United States... ...(QA) activities. Advance the writing of documents as part of the quality... ..., etc.), by both actively leading the development of documents... ...in preparations for regulatory inspections, which may include...RegulatoryWork at office
Nextonic Solutions LLC
Bethesda, MD4 days ago $30 per hour
...Clinical Research Coordinator Job Description Concentric Methods is seeking an experienced... ..., including the course Ethical and Regulatory Aspects of Clinical Research and the Empirical... ...adverse events. Assists staff in writing progress reports and contributions to peer...RegulatoryHourly payCape Fox Corporation
Bethesda, MD8 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Strategic Lead, Clinical Regulatory Writing. Be the first to apply!
