Senior Medical Writer: Regulatory Submissions & Study Leadership
MMS
MMS is looking for a skilled Medical Writer to join their team in Phoenix, Arizona. In this role, you will critically evaluate medical literature and produce high-quality regulatory documents, including clinical protocols and study reports. The ideal candidate will have at least 3-5 years of regulatory writing experience and a strong understanding of the pharmaceutical industry. Exceptional writing skills and expertise in MS Office are required. The position is an opportunity to contribute to improving lives through innovative therapies. #J-18808-Ljbffr MMS
- ...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... ...materials for adequate study design, statistical significance...SeniorRegulatoryRemote jobWorldwide
- ...Experience 2+ years of global study management experience... ...ensure compliance with ICH-GCP, regulatory requirements, and study protocols... ...that combines strategic leadership, operational execution, and... ...and ensure timely document submission Develop quality monitoring plans...SeniorRegulatoryContract workWork at officeWorldwide
- Sr Medical Writer Publications - Sponsor Dedicated - Remote Based Syneos... ...associated with individual studies, coordinating medical writing... .... Adheres to established regulatory standards, including, but not... ...changes to medical writing leadership. Completes required administrative...SeniorRegulatoryRemote jobContract workFlexible hours
- ...hands-on experience in clinical operations, regulatory compliance, and staff management.... ...least one year of clinical experience in a senior living or related healthcare setting. The CDIT will participate in a structured leadership training program and collaboratively work...SeniorRegulatory
- ...leading biopharmaceutical solutions organization is seeking a Sr Medical Writer for remote-based opportunities. The role involves leading... ...life sciences, proven experience in medical writing, and strong regulatory knowledge. The position offers valuable benefits including...SeniorRegulatoryRemote jobFlexible hours
$70.1k - $145k
Syneos Health/inVentiv Health Commercial LLC is seeking a Senior Medical Writer based in Arizona. The role involves preparing clinical documents, ensuring adherence to regulatory standards, and mentoring junior writers. The ideal candidate should have a Bachelor's degree...SeniorRegulatory- ...'ll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for... ...take pride in our accessible Executive Leadership team, who are equally committed to... ...involved in all stages of the clinical study, including identifying potential sites...SeniorRegulatoryRemote jobWork at officeWorldwide
$288.2k - $360.2k
...Risk Management (PVRM) Senior Medical Director will be... ...Plan (SMP), Clinical Study report (CSR), Investigator... ...labels, RMP/REMS, Regulatory Authorities safety inquiries... ...and keeping senior leadership informed of safety... ...in NDA/BLA/MAA submissions Lead ongoing safety monitoring...SeniorRegulatoryWork at officeLocal areaRemote workWorldwideFlexible hours$284.32k - $355.4k
...for the position of Senior Medical Director, Clinical Research... ...related to clinical study design from study... ...appropriate scientific/regulatory/medical standards.... ...Experience in regulatory submissions in US; preferred... ...environment. · Strong team leadership skills and ability to...SeniorRegulatoryWorldwideFlexible hours$230.72k - $345k
...Job Summary The Senior Director, Biostatistics, provides leadership, oversight, and technical... ...modeling and simulation, regulatory submission support, advisory... ...development process, from study design and development... ...: Comprehensive medical, dental, vision, prescription...SeniorRegulatoryTemporary workLocal areaFlexible hours- ...statistical efforts for clinical trials with major Pharma clients. This role involves providing statistical leadership, contributing to regulatory submissions, and managing cross-functional teams. The ideal candidate will have 6+ years of experience in pharmaceuticals...SeniorRegulatory
- ...The Project Leadership function at Parexel is a critical part of... ...the Project Leader (PM) and Senior Project Leader (SPM) level... ...experience leading global studies in a variety of therapeutics... ...development process through regulatory submissions. Additional years of experience...RegulatoryRemote work
- ...personal development. Applicants should have an undergraduate degree and preferably experience in financial or client services. Note that regulatory licenses may be required for specific roles, and visa sponsorship is not available. #J-18808-Ljbffr The Vanguard GroupSeniorRegulatoryRotational program
$110k - $145k
...exciting opportunity for a Senior Environmental Planning... ...deliverables. Provide leadership in mentoring personnel... ...and technical studies for transportation projects... ...on or understanding regulatory and permitting requirements... ...benefits may include medical, dental, vision, life,...SeniorRegulatoryFor subcontractorWork at officeLocal areaFlexible hours- ...The Project Leadership function at Parexel is a critical part of... ...the Project Leader (PM) and Senior Project Leader (SPM level for... ...experience leading global studies in a variety of... ...development process through regulatory submissions. Additional years of experience...RegulatoryRemote workWork from home
- Senior Project Manager - Substation Engineering Location: Phoenix... ...Southwest. This is a key leadership position for an experienced... ...operators to support technical submissions and agreements. Maintain a... ...processes and related regulatory documentation. Strong written...SeniorRegulatoryRelocation
- ...healthcare professionals for future roles as Clinical Directors. This position involves hands-on experience in clinical operations, regulatory compliance, and staff management within a wellness department. The ideal candidate will engage in a structured training program...SeniorRegulatoryFull time
- ...career! Job title - Senior Engineer / Project Manager... ...needs additional leadership to maintain our current... ...manage projects through study, design and... ...Communicating with regulatory agencies, vendors, contractors... ...insurance package including medical, dental, vision, FSA,...SeniorRegulatoryTemporary workFor contractorsWork at officeLocal areaFlexible hours
- ...Senior Project Manager Looking for a place to grow... ...processes ~ Strong leadership skills with the... ...preliminary engineering design studies Experience with... ...preparation and processing of regulatory plans Knowledge of... ...bonus potential Medical, dental, vision,...SeniorRegulatoryLocal area
- ...Senior Project Manager Project based in New Mexico. Mission Critical... ..., company guidelines, and regulatory compliance. The Project... ...customer relationships. Team Leadership: Oversee multiple projects, providing... ...preferred. Equivalent studies or experience will be...SeniorRegulatoryFor contractorsApprenticeship
- ...begins. Position Summary The Clinical Study Documentation Specialist provides clinical... ...standard operating procedures (SOPs), regulatory requirements, and industry best practices... ...coordinating Institutional Review Board (IRB) submissions, engaging with research sites through...RegulatoryWork at officeLocal area
- ...responsibility for the delivery of the studies at allocated sites and is an... ...for study start-up and regulatory maintenance. Tasks may... ...for the application process; submission of proper application/documents... .... Collaborates with local Medical Science Liaisons (MSLs) as directed...SeniorRegulatoryLocal areaRemote workFlexible hoursShift work
$66.5k - $88.02k
...Cardinal Health is seeking a Sr Regulatory Affairs Specialist to join their Medical Solutions Regulatory Affairs team. This remote position requires regulatory... ..., including new product development and regulatory submissions. Ideal candidates will have 2+ years of experience...SeniorRegulatoryRemote work- ...management activities for the client Sponsored studies. Site monitoring and site management... ..., monitoring plan, ICH GCP, local regulatory requirements, and client SOPs. Conduct... ...regulatory files are current and verify timely submission of study documentation, including safety...SeniorRegulatoryInterim roleLocal areaRemote work
- ...Senior Instructional Designer The Senior Instructional... ..., customer service, regulatory compliance, workflow... ...scenarios, case studies, and interactive activities... ...improvement to leadership Provide editing and... ...physical disability, medical condition, genetic information...SeniorRegulatoryWork experience placementWork at officeLocal area
- ...Job Summary The Senior Clinical Research Associate... ...for the delivery of the studies at allocated sites and... ...study start-up and regulatory maintenance. Tasks may... ...application process; submission of proper application/... ...Collaborates with local Medical Scientific Liaisons (MSLs...SeniorRegulatoryLocal areaRemote workFlexible hoursShift work
- ...Description Job Description Senior Mechanical Design Engineer... ...engineering expertise with technical leadership, providing guidance and... ...protocols, and engineering studies to verify design performance... ...with performance, safety, and regulatory requirements. Collaborate...SeniorRegulatory
- ...looking for an experienced Senior Tax Manager to join... ...Do: Provide overall leadership and oversight for all... ...calculation, review, and submission of Federal, State, and... ...rules. Monitor regulatory developments affecting... ...Pet Discount Program Medical Insurance – Company pays...SeniorRegulatoryTemporary workPart timeInterim roleLocal areaFlexible hours
- ...in Phoenix is hiring a Water Wastewater Engineer to provide technical leadership on key projects. The role involves managing client relationships, supervising engineers, and liaising with regulatory agencies. Candidates should have a minimum of 7 years in the water/wastewater...SeniorRegulatory
- ...currently initiating a search for a Senior Geologist/Senior... ...ability to navigate complex regulatory environments ensuring project... ...inspections, and environmental studies and surveys to gain further information... ..., etc.) Highly capable self-leadership and interpersonal...SeniorRegulatoryWork at office
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