Senior Medical Writer & Regulatory Strategy Lead
Axle
Axle is seeking a Senior Medical Writer & Regulatory Affairs Consultant to support the NIH Blueprint Neurotherapeutics Network (BPN) at NIH in Rockville, MD. This role provides scientific leadership and regulatory expertise throughout drug discovery and development by preparing, reviewing, and coordinating regulatory submissions, ensuring FDA and ICH compliance. The successful candidate will collaborate with multidisciplinary teams to develop regulatory documentation, provide strategic #J-18808-Ljbffr Axle
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Medical Writer & Regulatory Strategy Lead in Rockville, MD vacancy
- ...in Chevy Chase, MD is seeking a Transmission Manager to lead interconnection and transmission strategy for nuclear power projects across U.S. markets. You will guide siting, development strategy, and regulatory engagement with a focus on PJM, ERCOT, MISO, NYISO, and SERC...SeniorRegulatory
$221.93k - $369.88k
...therapeutic head within Labelling Strategy and Governance, you will lead a global labelling team... ..., and deliver practical regulatory solutions. This role... .... Advise Regulatory and senior management on issues... ...strategy with commercial and medical affairs objectives. Track...SeniorRegulatoryLocal area2 days per week3 days per week- ...seeks a Government General Counsel to serve as the organization’s senior legal authority on government-related matters. You will... ...focuses on interpreting federal, state, and local laws, ensuring regulatory compliance, reviewing contracts, and guiding leadership on enforcement...SeniorRegulatoryLocal area
- ...LifeScience in Gaithersburg, MD seeks an experiencedClinical Regulatory Writing Associate Director to lead regulatory writing across a complex program portfolio... ...collaboration. The role requires leading submission strategies (cSCS), mentoring teams, translating complex data...SeniorRegulatory
- GSK is seeking a therapeutic head within Labelling Strategy and Governance to lead a global oncology labelling team. You will ensure clear, compliant... ...care and product success, engaging with R&D, Safety, Regulatory, and Commercial stakeholders. The role offers visible...SeniorRegulatory
- Socket.dev is seeking a senior leader to drive development and delivery of novel therapies... ...expertise. You will integrate research strategies, design robust studies, and oversee... ...coordinating CROs, steering committees, regulatory submissions, and cross-border collaboration...SeniorRegulatory
- ...client is expanding and seeks a Senior Director of Product Management and Strategy. The ideal candidate will own... ...technical engineering teams, and leads with both quantitative rigor and... ...on customer engagement Manage regulatory compliance (FDA, CE, ISO 13485)...SeniorRegulatory
Gables Search Group
Gaithersburg, MDa month ago - AstraZeneca is seeking a Regulatory Affairs Manager to lead end-to-end regulatory deliverables across global markets. You will coordinate submission strategies, assess risks, and guide cross-functional teams on regulatory requirements throughout the product lifecycle....Regulatory
- The Medical Writer collaborates with members of cross-functional teams to prepare high-quality... ..., investigator brochures, synopses, regulatory documents, clinical publications, and related... ...with department management to set strategy for meeting department goals Qualifications...SeniorRegulatory
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston,... ...real options for patients? This role leads high-impact programs across cancer,... ...; and, health benefits including medical, prescription drug, dental, and vision...SeniorRegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- DAVIS seeks a Virtual Construction Manager to lead BIM/VC strategy and coordination across multiple projects. You will bridge executive project management with BIM execution, ensuring digital workflows support schedule, cost, risk, and field execution. The role demands...Senior
- ...clinical research organization is seeking an Ophthalmology Strategy and Medical Monitor. This role involves strategic medical leadership and... ...documents, interfacing with experts, and supporting regulatory processes. Competitive benefits include flexible time off and...RegulatoryRemote workFlexible hours
EMMES Corporation
Rockville, MD1 day ago $167k - $251k
...both internal scenarios and regulatory frameworks (e.g., DFAST).As an... ...changes, and evaluate portfolio strategies such as loss mitigation and... ...while developing and leading talent in a fast-paced, mission... ...Chief Risk Officer in providing senior management and the Board with...SeniorRegulatoryLocal area$243.59k - $365.38k
...Summary:Reporting to the Global Medical Head of CardioRenal, the Senior GMAL is a highly experienced... .... This individual develops and leads bold medical strategies within the CardioRenal therapy... ...of healthcare system pathways, regulatory landscapes, market access, and...SeniorRegulatoryFull timeTemporary workWorldwide- ...inform risk appetite and capital resilience under internal and regulatory scenarios. You will challenge models, strengthen governance,... ...model risk and business units to monitor KRIs, evaluate portfolio strategies, and drive data-driven oversight while developing #J-18808-...SeniorRegulatory
- ...candidate will manage sample analysis and method validation projects, providing technical guidance and ensuring compliance with regulatory standards. Qualifications include a Ph.D. in a related field, with at least 4 years of hands-on laboratory experience. Proficiency...SeniorRegulatory
- ...while providing technical guidance and ensuring studies meet regulatory standards. The ideal candidate has a Ph.D. in a related field,... ...The position offers competitive salary and benefits, including medical, dental, and a 401(k) match. #J-18808-Ljbffr MESO SCALE DIAGNOSTICS...SeniorRegulatory
- Apex Companies, LLC is seeking a Senior Hydrogeologist to join our Northeast Division in a hybrid role. You will manage and deliver water... ...projects across New England, including groundwater studies and regulatory support. The ideal candidate has a geology/hydrogeology...SeniorRegulatory
- Insight Global is seeking a Senior Manager of Proposals to lead a high-visibility, mission-driven government... ..., compelling content and winning strategies. You will build scalable processes,... ...team reviews, and mentor a team of writers and coordinators while elevating governance...Senior
- Blue Energy seeks a Director of Contracts to lead the commercial backbone of its supply chain. You will set contracting strategy, run competitive sourcing, negotiate and... ...providers. You’ll translate nuclear quality and regulatory requirements into actionable supplier...SeniorRegulatory
- Sunrise Senior Living, LLC is seeking an Area Human Resources Manager to lead HR strategy across multiple communities, including recruitment, onboarding, and compliance.... ...will manage HRIS/ATS, employee relations, and regulatory documentation while partnering with...SeniorRegulatory
- People Stretch Solutions is seeking a Senior Manager/Director to own end-to-end client engagements in strategy and AI governance. You will partner with the Founder to shape work, run engagements independently, and present to senior stakeholders. This hands-on role sits...Senior
$198.7k - $391.6k
...advancing access to healthcare, and leading a well-being revolution.... ...formulate consumer-driven strategies to engineer a digitally enabled... ...Care Marketing Strategy Senior Manager is a client-facing consulting... ...An evolving customer and regulatory landscape, cost and operational...SeniorRegulatoryLocal areaFlexible hours$198.7k - $391.6k
...Summary The Experience Design Strategy Senior Manager is a client-facing... ...at the executive level and leading cross-functional teams through... ...An evolving customer and regulatory landscape, mounting pipeline... ...firms to global big pharma to medical device companies—to drive business...SeniorRegulatoryLocal area$136k - $204k
Freddie Mac is seeking a senior role focusing on capital markets to manage interest rate and liquidity risk. You will mentor junior team members while developing strategies that influence Freddie Mac's enterprise strategies. Applicants should have extensive experience in...Senior- Appian Corporation in McLean, VA, seeks an experienced Customer Success Strategy and Operations professional to join their team. This role involves leading customer satisfaction programs and initiatives that enhance enterprise customer experiences with Appian. The ideal...Senior
- A leading financial services firm in Virginia seeks an experienced analyst to identify business challenges, recommend solutions, and support product strategies. The ideal candidate has a Bachelor's or Master's degree in a quantitative field, with 2+ years of analysis experience...Senior
- Capital One is hiring a Senior Manager, In-person Experience Strategy in McLean, VA. You will lead a team focused on customer experience measurement, in-store improvements for cafes and branches, and strategic project intent. Responsibilities include developing growth-...Senior
$85.94k - $137.91k
...vulnerable children, adults and seniors. The Department provides... ...Department. This position will lead and conduct complex fiscal reviews... ...internal controls, ensure regulatory alignment, and support... ...Accounting or a major in Accounting. Medical Protocol: This position...SeniorRegulatoryRemote work- GEICO in Bethesda, MD seeks a Lead II, Media Strategy & Planning to translate business briefs into integrated media strategies across TV, digital, and OOH. You’ll partner with agency teams and internal stakeholders to ensure plans align with objectives and optimize based...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Medical Writer & Regulatory Strategy Lead. Be the first to apply!
Related searches
- senior technology project manager Rockville, MD
- remote senior business analyst Rockville, MD
- senior leadership Rockville, MD
- senior grant accountant Rockville, MD
- senior storage engineer Rockville, MD
- senior manager automotive Rockville, MD
- senior magento developer Rockville, MD
- senior application administrator Rockville, MD
- senior java full-stack developer Rockville, MD
- senior accountant work from home Rockville, MD