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 2 days ago
Similar jobs that could be interesting for youBased on the Strategic Lead, Clinical Regulatory Writing in Gaithersburg, MD vacancy
- ...The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and... ...development. Our vision is to be an industry leading organization driving strategic...Regulatory
Zenith LifeScience
Gaithersburg, MD3 days 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, MD2 days ago$133.04k - $199.56k
...Job Title: Clinical Regulatory Writer, Associate Director / Manager Location... ...in Clinical Regulatory Writing, you'll play a pivotal role... ...to drug projects, authoring strategically important clinical-regulatory... ...acting as a submission lead. Lead internal/external authoring...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per weekAstraZeneca
Gaithersburg, MD1 day ago- ..., all the way to late‑stage trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials).... ...to deliver compelling preclinical, clinical and translational data packages providing... .... Summary of Role The Director, Strategic Projects & Organizational...RegulatoryHourly payLong term contractTemporary workWork at office
- Responsibilities: Provide regulatory leadership for assigned development... ..., and agency liaison. Lead US and ex-US regulatory activities... .... Lead creation and writing of regulatory submission documents... ...Oversee regulatory review of clinical trial labeling and CMC submissions...RegulatoryFull timeLocal areaNight shift
$245k - $392k
...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$133.04k - $199.56k
...GmbH in Gaithersburg, MD, is hiring a Clinical Regulatory Writer, Associate Director/Manager. This... ...Sciences and at least 7 years of medical writing experience in the pharmaceutical... ...significant regulatory documents, and lead communication projects to support drug...Regulatory3 days per week$121.5k - $202.5k
...Overview The Senior Manager, Clinical Supply Chain Program Lead will be a leader of cross... ...with Clinical Operation, Regulatory, Medical Affairs,... ...supply chain strategy and strategic direction of supply for clinical... ...system, including writing and reviewing SOPs When...RegulatoryFor contractors- AstraZeneca is seeking a Global Clinical Program Lead (GCPL) to lead clinical development strategies for hematology therapies. The successful... ...the clinical strategy for multiple projects, ensuring regulatory compliance and successful execution across various phases....Regulatory
$70k - $85k
...Insider, Inc. is seeking a Senior Clinical Research Coordinator in Rockville, MD, responsible for executing and coordinating clinical... ...care, study operations oversight, and ensuring compliance with regulatory guidelines. Candidates must have a nursing or bachelor's...RegulatoryFull timeINSIDER
Rockville, MD2 days ago- A leading biopharmaceutical company in Maryland is seeking a seasoned statistical leader to oversee strategic contributions to product development and regulatory strategy. The candidate will mentor statistical... ...demonstrate leadership skills in clinical trials. Strong...RegulatoryFlexible hours
$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, MD3 days ago$26 - $27 per hour
...About Us CenExel is a leading nationwide clinical research site and patient network serving the life... ...compliance. Perform administrative and regulatory duties related to the study as appropriate... ...communicate verbally and in writing. Working Conditions Indoor, office environment...RegulatoryFull timeWork at officeShift workNight shiftCenExel
Gaithersburg, MD1 day ago- The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for... ...optimization. They will provide tactical and strategic input and leadership across... ...(e.g., commercial, research, clinical development, medical affairs, business...Regulatory
$300k - $325k
...MD, is seeking a Senior Licensing Fellow to provide strategic leadership for the Licensing and Regulatory Affairs organization. This role will set strategic direction... ...have extensive experience in regulatory affairs, leading high-stakes external engagements, and a proven track...Regulatory$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- ...Global Clinical Development Medical Director Hybrid Working: 3... ...Patient Safety, Biometrics, Regulatory Affairs, Clinical Operations,... ...Adverse Events and review and writing of safety narrative reports... ...field. Building on this, we lead the way into the future with...RegulatoryHourly payTemporary workWork at officeFlexible hours3 days per week
- 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, MD4 days ago - ...Inhaled COPD and plays a vital strategic business role. As an... .... The Global Medical Affairs Lead (GMAL) for Breztri/Trixeo will... ...dialogue to reinforce Breztri’s clinical value proposition. Guideline... ..., Commercial, Market Access, Regulatory, Safety, and Digital/Analytics...RegulatoryHourly payTemporary workLocal area
- A financial regulatory organization in Maryland is seeking a Vice President, Litigation to lead complex litigation and manage the OGC Litigation Office. This role requires... ...litigation matters. The ideal candidate will provide strategic counsel, oversee outside counsel, and report...RegulatoryWork at office
- ...Oncology Biometrics Leadership: Lead a team of specialists who... ...projects maintaining adherence to regulatory standards and scientific... ...and compliance with Oncology clinical data standards, relevant data... ...Workforce Planning: Input to the OBM Strategic Workforce Planning in terms...RegulatoryHourly payTemporary work
- Scorpion Therapeutics in Gaithersburg, MD is looking for a Regulatory Lead to provide regulatory leadership for development projects. This role involves developing strategic regulatory approaches, managing regulatory submissions to agencies like the FDA, and establishing...RegulatoryFull time
- ...NASDAQ: ALT) is a late clinical-stage... ...diseases. The Company's lead candidate, pemvidutide... ...Content Creation: Write and produce high-quality... ...develop and implement strategic communication plans, including... ...content Familiarity with regulatory and compliance guidelines...RegulatoryFull timeWork experience placementLocal area
Altimmune, Inc.
Gaithersburg, MD2 days ago - ...Global Clinical Program Lead, Late Development Oncology Hybrid Working: Minimum 3 days per week... ...into pivotal trials that withstand regulatory scrutiny and deliver real-world impact... ...international collaborators; apply strategic intent in interactions with authorities...RegulatoryWork at officeLocal areaFlexible hours3 days per week
$65k - $90k
...Description Are you driven to grow, lead, and make a meaningful impact... ...client retention, and strategic acquisitions, Apex Companies... ...staff ~ Strong technical writing and communication skills ~... ...Experience with permitting or regulatory coordination is a plus ~ Experience...RegulatoryTemporary workWork at officeNight shift$200k - $275k
...for excellence, with a global presence in strategic locations like Boston, New York, and... ...understanding of the patent process and regulatory landscape. Business-minded approach to... ...patent strategy. Excellent communication, writing, and analytical skills. Self-...RegulatoryWork at officeLocal areaJobot
Gaithersburg, MD7 hours ago$62.4k - $79.04k
...LLC in Gaithersburg is seeking a Sterile Processing Manager to lead the sterilization processes of surgical instruments. This role... ...includes developing training programs and ensuring compliance with regulatory standards within a state-of-the-art facility. The ideal...RegulatoryCenters For Advanced Orthopaedics, LLC
Gaithersburg, MD14 hours ago- ..., all the way to late-stage trials leading to drug approval by regulatory agencies (Phase 1, 2 and 3 trials).... ...to deliver compelling preclinical, clinical and translational data packages providing... ...will be accountable for the strategic clinical development plan and clinical...RegulatoryHourly payTemporary work
$130k - $185k
...the Area Chief of Staff is to lead, develop and manage associate... ...managers. Validate the clinical skillset and alignment with quality... ...all local, state and federal regulatory requirements including but... ...and language ability (reading, writing, and speaking the English language...RegulatoryFull timeTemporary workPart timeLocal areaFlexible hoursShift workBanfield Pet Hospitals
North Potomac, MD1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Strategic Lead, Clinical Regulatory Writing. Be the first to apply!
Related searches