Strategic Director of Medical Writing & Regulatory Submissions
Inventiva Pharma
Inventiva Pharma in Massachusetts is seeking an Executive Director, Head of Medical Writing to lead its medical writing function. This strategic role involves overseeing the planning and development of clinical and regulatory documents to ensure scientific accuracy and compliance. The position requires a PhD or equivalent, with over 12 years of medical writing experience and a proven ability in regulatory submissions. Join us to play a central role in bringing transformative therapies to patients. #J-18808-Ljbffr Inventiva Pharma
- 6AM City, LLC is seeking an experienced Senior Medical Writer to join its team in Massachusetts. The role involves writing and editing clinical reports and documents required for regulatory submissions. Ideal candidates should have 10+ years of medical writing experience...MedicalRegulatory
- Sr. Principal Regulatory Medical Writer - Oncology (Preferred) at Syneos Health/ inVentiv Health... ...regulatory documents for global submissions in line with ICH guidelines and internal... ...and leading cross-functional input on writing deliverables. The position seeks expertise...MedicalRegulatory
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Travere Therapeutics is seeking an Associate Director, Medical Writing to oversee regulatory submissions. The candidate will manage medical writing projects, ensuring timely delivery of high-quality documents compliant with regulatory standards. Qualified candidates should...MedicalRegulatoryRemote work$116k - $128k
Veristat, LLC. is looking for a Senior Medical Writer with a clinical focus, responsible for leading document authorship across various projects. This role demands a strong background in regulatory writing and clinical documentation, with at least 3 years of experience...MedicalRegulatoryRemote jobFlexible hours- ...organization in the United States, seeks a Senior Medical Writer – Clinical Focus to lead document... ...part of a delivery team. You will guide regulatory documentation, ensure adherence to... ..., and contribute to the development of submission documents such as CSRs, IMs, and...MedicalRegulatoryRemote work
$95k - $210.9k
...Sr. Principal Regulatory Medical Writer - Oncology (Preferred) Job Responsibilities Develop regulatory documents for submission to regulatory agencies globally including Clinical Study Reports... ...corporate objectives. Manage medical writing projects, including developing...MedicalRegulatoryContract workFlexible hours- ...someone who can provide strategic and operational... ...compliance with global regulatory requirements and organizational... ...Clinical, Regulatory, Medical Affairs, etc) Oversee... ...data Ensure timely submission of safety reports to... ...report generation and writing are consistent with our...MedicalRegulatoryContract work
- ...: THE OPPORTUNITY The Executive Director, Head of Medical Writing is a strategic, hands-on leader responsible for... ...delivery of high-quality clinical and regulatory documents, ensuring scientific... ...supporting regulatory submissions, health authority interactions, and...MedicalRegulatoryContract work
$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA... ...Position Summary The Director, Regulatory Affairs Strategy... ...programs and provides strategic guidance to cross-... ...Clinical Operations, Medical Affairs, Biostatistics... ...requirements. Regulatory Submissions Oversee the...MedicalRegulatoryTemporary workLocal areaRemote workWeekend work- ...in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the... ...including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews...MedicalRegulatory
- Discover International is seeking a Director of Regulatory Affairs CMC to oversee CMC regulatory... ...with responsibilities including major submissions and Health Authority interactions. The... ...experience, capable of balancing strategic oversight with detailed execution, and...Regulatory
$145k - $165k
...Corporate Compliance Director. The Compliance Manager... ...that support FUJIFILM’s Medical Device Compliance... ...with review of quotes, submissions, and other documentation... ...Legal, IT, HR, Finance, Regulatory and other core... ...Excellent interpersonal, writing and communication skills...MedicalRegulatoryRemote workFlexible hours$116k - $151k
Department: 107000 Regulatory Location: San Diego, USA- Remote Be a part of a global... ...teams to support regulatory planning, submission execution, Health Authority interactions... ..., CMC, Regulatory Operations, Medical Writing, and Project Management teams to support...MedicalRegulatoryContract workTemporary workRemote work$21 - $29.01 per hour
...teams drive groundbreaking medical discoveries and invite all applicants... ...procedures. -Assists with regulatory binders and QA/QC Procedures... ...with study regulator submissions.**Qualifications**Education... ...collection needed for manuscript writing/publications, and conduct...MedicalRegulatoryHourly payDaily paidRemote workWork from homeShift work- ...Nurse Scientist leads a strategic program of nursing... ...with ethical, legal, regulatory, and institutional standards... ..., and scholarly writing. Support students and... ...abstract development, and submission processes. Encourage... ...including PTO, 401(k), medical and dental plans, and...MedicalRegulatory
$130.5k - $154.5k
...to effectively communicate orally and in writing, providing quality acquisition and... ...acquisition reports, including statutory and regulatory reports (i.e., Defense Acquisition Executive... ...travel, including air travel. Benefits Medical/Dental/Vision Insurance 401(k) plan with...MedicalRegulatoryPermanent employmentFlexible hours$116k - $151k
Department: 107050 Medical Writing Location: San Diego, USA- Remote Be a part of a global... ...function and for authoring and coordinating regulatory, clinical, and safety documents. This... ...with regulatory requirements, and submission ready. In addition to supporting the...MedicalRegulatoryTemporary workRemote workShift work$116k - $128k
Senior Medical Writer - Clinical Focus Position: Senior Medical Writer - Clinical Focus... ...Bachelor’s degree. 3+ years of regulatory writing experience or equivalent experience with... ...acceptance. Experience in the development of submission-level documents (does not require...MedicalRegulatoryRemote workFlexible hours$164.53k - $245.99k
...Description The Associate Director, Scientific... ...scientific and medical communications... ...Clinical Development, Regulatory, Commercial).... ...timely and compliant submission of high-quality... ...and medical writing agencies to ensure... ...Stay focused on key strategic objectives, be accountable...MedicalRegulatoryTemporary workLocal areaFlexible hours- ...Director, Clinical Scientist, Respiratory About the Company... ...presentations, as well as ensuring regulatory compliance and contributing... ...excellent communication, technical writing, and presentation skills, and... ...Functions ~ Medical Care/Hospital Administration...MedicalRegulatory
- ...occasional travel for inspections, audits, regulatory engagement, and incident response.... ...Experience in industry (pharmaceutical, medical, DEA) (preferred) Environmental consulting... ...experience (preferred) Excellent communication, writing, and presentation skills Strong...MedicalRegulatoryFull timeFor contractorsLocal area
$28.08 - $42.87 per hour
...been provided. Each application submission is reviewed independently.... ...accordance with the Oklahoma Medical Marijuana and Patient Protection... ...processes in compliance with regulatory and department requirements.... ...communicating verbally, in writing, or by physical demonstration...MedicalRegulatoryHourly payFull timeShift work$116k - $128k
...Synchrogenix Information Strategies, LLC is looking for a Senior Medical Writer specializing in clinical documentation. This role... ...candidate will have a Bachelor's degree and over 3 years of regulatory writing experience. A strong proficiency in Microsoft Word and a...MedicalRegulatoryRemote work- ...Interfacing with state and local regulatory agencies and permitting... ...funding programs. Excellent writing, communication, and... ...long‑term disability Health: Medical plan options; plus dental and... ...unsolicited resumes or candidate submissions from recruitment agencies. Any...MedicalRegulatoryContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaRemote workFlexible hours
$136k - $197.5k
Boston Medical Center is seeking a Director of Pharmacy to lead the pharmacy department, ensuring high-quality patient care and regulatory compliance. You will manage budgets, oversee staffing, and collaborate with healthcare professionals. The ideal candidate holds a PharmD...MedicalRegulatory$110k - $115k
...supports quality of care and regulatory adherence by reviewing documentation... ...needs. Conduct audits of medical records to verify that... ...requirements and experience writing and developing policies and process... ...for MDS-HC review and submission. Excellent attention to detail...MedicalRegulatoryWork at officeLocal area- ...in accordance with government, company, regulatory board, and client specific guidelines. Documents... .... Exceptional analytical and narrative writing skills. Ability to analyze data, draw... ...benefits package including medical, dental, vision, 401(k), PTO/paid sick leave...MedicalRegulatory
- ...Associate Director/Director Strategy, Real World Evidence and Late Phase Job Responsibilities... ...to leadership Coordinate the necessary medical/scientific input from outside experts/... ...functional areas Thorough knowledge of regulatory requirements and the clinical development...MedicalRegulatoryContract work
- ...and consultants on legal, transactional, regulatory, and compliance matters. Note: This is a... ...exclusions, plan document terms, and medical necessity disputes to determine appropriate... ...ERISA, MHPAEA, and HIPAA Superior legal writing, analytical, and proofreading skills, as...MedicalRegulatoryFull timeWork at officeFlexible hours
- ...assistance to the F/B Directorate Chief Financial Officer... ..., oral or in writing, that address the designated... ...response to concerns with regulatory compliance, and/or... ...Checkbook Reports, POM submission data; Research, Development... ...Health Care Plan (Medical, Dental & Vision) Retirement...MedicalRegulatoryContract workTemporary workFor contractorsWork at officeImmediate start
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