Lead Medical Writer, Regulatory Submissions & Strategy
IQVIA
IQVIA is seeking an experienced Principal Medical Writer to lead the development of clinical and regulatory documents for global submissions, including IBs, CSRs, and module II summaries. You will ensure scientific accuracy, consistency, and alignment with program objectives and regulatory requirements. You will act as lead writer for key summary documents, guide cross-functional teams, and oversee medical writing activities across multiple programs, reporting to the Director of Medical Writing #J-18808-Ljbffr IQVIA
- Syneos Health is seeking a principal medical writer to lead the development and review of complex regulatory and scientific documents, ensuring accuracy and alignment with client goals and regulatory guidelines. The role includes mentoring junior writers, coordinating cross...RegulatoryRemote job
- ...Health in the United States is seeking a Sr Medical Writer for Late Phase inflammation programs. You will lead the creation and review of clinical documents... ...affairs to deliver high-quality manuscripts and regulatory submissions. The role requires mentorship of junior...RegulatoryRemote job
- ...Pharmaceuticals in the United States is seeking a Regulatory Affairs Manager to oversee regulatory activities for... ...teams. You will author Health Authority submissions for US and Canada, shape regulatory strategies for drug product registration and lifecycle management...Regulatory
- Important Application Submission InformationIn order to ensure your... ...platform implementation, product strategy and roadmapDrive out the... ..., new providers and regulatory trends, and areas of focusLeads... ...Preferred QualificationsExperience leading or coordinating cross-...RegulatoryLong term contractFull timeWork experience placementWork at officeRemote workVisa sponsorshipRelocation package
- Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products... ...teams in North America. You will author HA submissions for US and Canada, guide strategy, and ensure compliance with regulations and Azurity standards...Regulatory
- MMS is seeking a Regulatory Writing professional to join our remote team. The role focuses on development, writing, and... ...documents, including Module 2.4 and 2.6 eCTD submissions, IBs, and GLP data. You will lead projects, ensure regulatory alignment, and communicate...RegulatoryRemote job
- Syneos Health is seeking a senior Medical Writer to lead the production of high-quality medical writing deliverables across multiple study documents, coordinating with data management, biostatistics, regulatory affairs, and medical affairs. You will ensure regulatory compliance...Regulatory
- ProPharma in Raleigh, NC seeks an experienced Medical Writer to lead clinical and regulatory documents across drug, biologic, and device programs. You will author, edit, and supervise deliverables, mentor junior writers, and ensure compliance with ICH E3/E6, FDA rules,...RegulatoryRemote job
- ...Raleigh, NC seeks an Associate Director/Director/Sr. Director, Regulatory CMC to lead global CMC regulatory strategy for clinical development and commercialization of biologics. You will guide submissions, risk mitigation, and cross-functional collaboration with Quality...Regulatory
- State Employees' Credit Union seeks a Lead Consumer Loan Product and Strategy Specialist to oversee the Consumer Loan Product and Strategy department... ...to lead cross-functional projects while ensuring regulatory compliance. #J-18808-Ljbffr State Employees' Credit UnionRegulatory
- PrimeVigilance, part of Ergomed Group, seeks an experienced Submission Specialist to support safety submissions and regulatory compliance in pharmacovigilance. You will collaborate with clients, manage submission processes, and help ensure quality in safety reporting....Regulatory
$179.5k - $356.5k
What The Oncology Therapeutic Strategy Lead Does At Worldwide The Oncology Therapeutic Strategy Lead will serve as a therapeutic... ...areas within the company, including clinical, medical, safety, program management, regulatory, technology, and business development operations to...RegulatoryWorldwideFlexible hours$136.1k - $252.8k
...individual legal use case.About the RoleThe Strategy and GTM Leader of Public Records will... ...KPIs for the team to measure success.Leads teams to make decisions where quantitative... ...businessLexisNexis Legal & Professional provides legal, regulatory, and business information and analytics...RegulatoryFull timeLocal areaImmediate startWorldwideFlexible hours- ...pharmaceutical, biotech, and medical device industries with a... ...approach to complex trial data and regulatory submission challenges. With a global... ...supervision, the Medical Writer will critically evaluate, analyze... ...protocol experience, as lead author, required Experience...RegulatoryRemote workWorldwide
- Affirm is seeking an Analytics Lead, Strategic Insights for Compliance Shared Services to own the compliance analytics and automated... ...a multi-product consumer lending business. You will translate regulatory obligations into automated data checks and turn data anomalies...RegulatoryRemote job
$84.4k - $211.1k
...Overview We are seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures...RegulatoryFull timePart timeImmediate startWorldwide- ...deep domain expertise in regulatory sciences, clinical... ...compliance, pharmacovigilance, medical information, and R&D... ...) as assigned. Leads cross-functional coordination... ..., NDA, BLA, MAA, eCTD submission level documents).... ...experienced medical writers, as necessary. Adheres...RegulatoryContract workWork at officeRemote work
$70k - $98k
...and societal value of creative medical treatments to payers,... ...revisions and works with clinical writers, account teams, production, and... ...with each client’s MLR submission process and support the MLR process... ...with the medical/legal/regulatory submission preparation as needed...RegulatoryWork at officeFlexible hours- A leading regulatory consulting firm is seeking a Regulatory Affairs Consultant to support ongoing projects in Raleigh, NC. This remote role involves developing regulatory strategies, leading regulatory submissions, and interacting with the FDA. An advanced degree in science...RegulatoryRemote jobPart time10 hours per week
- ...Industrial Technologies is seeking a Senior Calibration Technician to lead calibrations, PMs, and client-facing activities with strict... ..., scheduling, and profitability while ensuring safety and regulatory compliance. The role requires strong CMMS use, MAS500 Pivot Tables...Regulatory
$80.6k - $175.7k
Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK Updated: Yesterday Location... ...; NA/CAN/UK Syneos Health® is a leading fully-integrated life sciences... ...reports, clinical development plans; IND submissions; integrated summary reports; NDA and...RegulatoryContract workRemote workFlexible hours- ...align with EY’s global Information Security strategy. The role governs risk across the... ...regions and service lines. The candidate will lead risk assessments, stakeholder advisory,... ...current on external risk trends and regulatory changes to strengthen EY’s resilience and...Regulatory
- ...seeks a senior professional to lead global study start-up and... ...activation for assigned trials from strategy through execution. You will... ...across feasibility, regulatory, site contracts, and clinical... ...dependencies and regulatory submissions, and a proven ability to manage...Regulatory
$111k - $167k
...precise. Description The Regulatory Compliance Lead is a technically grounded... ...across consumer, research, and medical device (SaMD) product... ...systems for change control, submission tracking, and compliance... ...developing proactive mitigation strategies to maintain a strong...RegulatoryFull time- ...Inc. is seeking a Senior Manager of Peer-to-Peer Strategy & Engagement in the U.S. commercial Nephrology... ...cross-functional alignment across brand, field, medical, regulatory and agency teams. The ideal candidate will lead education objectives, optimize the Speaker Bureau...RegulatoryWork at office
- ...liquidity solutions, payments, FX, and trade finance. You will lead teams, set policies, ensure compliance, and collaborate with business... ...partners to deliver trusted, actionable data that supports performance and regulatory reporting. #J-18808-Ljbffr First Citizens BankRegulatory
- IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs in the US and globally... ...with potential extension. You will lead global labeling strategy, develop TPL for early-phase assets, oversee CTD submissions, and coordinate cross-functional...RegulatoryContract work
- ...experienced and proactive Team Lead for our AML/Compliance... ...understanding of internal controls, regulatory requirements, and a... ...ensuring accurate and timely submission. Provide insights and recommendations... ...and Senior Analysts to refine strategies, drive operational...Regulatory
- AskBio Inc., a Bayer subsidiary, seeks a senior Regulatory Affairs leader to drive global regulatory strategies for gene therapy programs. The role focuses... ...U.S., EU, and ROW. The position involves leading regulatory submissions, agency interactions, and development-stage...RegulatoryRemote job
$75k - $122.5k
...Scientific Associate, you will write medical content for our clients while... ..., advisory boards, strategy guides, monographs, discussion... .... Attending medical, legal, regulatory review meetings. Participating... .... Mentoring junior level writers. Qualifications Doctorate level...Regulatory
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