Senior Medical Writer: Regulatory & Clinical Trials Lead
MMS
MMS in Indianapolis seeks an experienced Medical Writer to critically evaluate literature, write regulatory documents, and lead writing projects across protocol development, study reports, and materials for regulatory submissions. The ideal candidate has 3–5 years in pharma regulatory writing, strong MS Word/Excel/PowerPoint skills, and a proven ability to manage teams and meet tight deadlines. #J-18808-Ljbffr MMS
- Lilly in Indianapolis, IN seeks a senior statistician to lead statistical analysis for clinical trials. You will collaborate with study teams, select methods, and communicate results for regulatory submissions and publications. The role requires a Master’s in Statistics...SeniorRegulatoryFull time
$65.25k - $148.5k
...invite you to join us. Purpose: The Clinical Development Trial Lead (CDTL) Associate leads the cross-functional... ...important trends such as industry, regulatory, new technology, etc.Manage TPO... ...vacation benefits; eligibility for medical, dental, vision and prescription drug...SeniorRegulatoryFull timeH1bLocal areaVisa sponsorshipWork visaFlexible hours- ...pharmaceutical, biotech, and medical device industries... ...approach to complex trial data and regulatory submission challenges... ..., the Medical Writer will critically evaluate... ...bias Write and edit clinical development documents... ...protocol experience, as lead author, required...SeniorRegulatoryRemote workWorldwide
- ...Indianapolis is seeking an experienced Data Manager to lead data management activities for complex trials. You will oversee study setup, data validation, and... ...skills. Join a growth-focused CRO and contribute to impactful regulatory submissions. #J-18808-Ljbffr MMSSeniorRegulatory
- ...Leader to drive study design, data collection, and quality across trials. You will guide the data lifecycle from setup to close-out,... ...experience, strong knowledge of EDC systems, and a commitment to GCP/ICH guidelines and regulatory standards. #J-18808-Ljbffr MMS Holdings IncSeniorRegulatory
- ...Overview Client is seeking experienced Clinical Development Trial Leads (CDTLs) to support global... ...Management, Clinical Operations, Regulatory Affairs, Medical, Safety, and other functional teams... ...environments. Experience operating at the Senior Manager or Associate Director...RegulatoryRemote work
$100.5k - $186.7k
...makes us Roche.The OpportunityAs a Clinical Development Lead (Medical & Scientific Writing), you will serve... ...and lifecycle management to support regulatory submissions and advance patient care... ...biostatistical methods and clinical trial data evaluation.Direct experience in...RegulatoryFull timeLocal areaRemote workRelocation package- ...IN seeks a Sr. Advisor - Statistics to lead statistical design and analysis for clinical trials, collaborating with physicians and scientists... ..., and communicating results for regulatory submissions and manuscripts with a senior, cross-functional team. Applicants should...SeniorRegulatory
- Lilly in Indianapolis, IN seeks a skilled statistician to support clinical trial analysis and regulatory submissions. You will collaborate with study teams, apply SAS and other tools, and contribute to statistical methods for complex trials. This full-time role offers...SeniorRegulatoryFull time
$100k - $120k
Real Chemistry is looking for a Senior Medical Copywriter to join our growing team! Job Summary The Senior Medical Copywriter represents... ...basis Identify and communicate important updates and medical‑regulatory milestones to the team and recommend new business...SeniorRegulatoryInternshipLocal areaRemote workFlexible hours- Community Health Network in Indianapolis is seeking a Research Regulatory Coordinator. The role involves leading regulatory activities for clinical trials, ensuring compliance with institutional policies and regulations. Candidates should have at least 3 years of research...SeniorRegulatory
- Elanco is seeking a Project Lead Data Manager to serve as a technical authority and strategic leader in achieving global clinical data management objectives. You will drive the end... ...Clinical Development, Biostatistics, and Regulatory Affairs to deliver submission-ready...Regulatory
$90.2k - $175.1k
...Team That’s Advancing Clinical ResearchWe’re looking... ...high-quality clinical trials. In this role, you’ll... ...study progress, including regulatory approvals, enrollment,... ...from you.IQVIA is a leading global provider of clinical... ...of innovative medical treatments to help improve...SeniorRegulatoryFull timePart timeImmediate startWorldwide$151k - $215k
...we do. As part of our Medical Affairs team, you'll... ...disseminate evidence-based clinical practices to help... ...journey. The Senior Principal Biostatistician... ...from clinical trial designs to regulatory submissions while applying... ...will make an impact: Lead end-to-end evidence...SeniorRegulatoryFull timeRemote work$93.1k - $232.8k
...patients faster.Drive global clinical trials from first site activation... ...point of contact for clients, lead cross-functional teams, and... ...ensure compliance with ICH-GCP, regulatory requirements, and study... ...commercialization of innovative medical treatments to help improve...SeniorRegulatoryFull timeContract workPart timeWork at officeImmediate startWorldwide- ...makes life better - join our team today!Job DescriptionYour Role:Clinical Trial Manager, Veterinary MedicineThis position will function in... ...and the global research and development teams to gain regulatory approval of these products.Your Responsibilities:Plan, manage...SeniorRegulatoryFull timeSummer workRelocation
$66k - $171.6k
...processes and increase capacity for clinical trial medicines, while also... ...technical reports and regulatory submissions dealing with the... ...and Women’s Initiative for Leading at Lilly (WILL).Actual compensation... ...benefits; eligibility for medical, dental, vision and prescription...SeniorRegulatoryPermanent employmentFull timeH1bVisa sponsorshipWork visaFlexible hours- ...Details#### Job Title:Senior Research Scientist- Internal... ...and Early Project Lead#### Location:,, ,####... ...who enjoys integrating clinical insight, experimental... ...research programs, clinical trials, comparative medicine... ...with applicable regulatory expectations, including...SeniorRegulatoryFull timeSummer workRelocationFlexible hours
- A leading clinical research organization is seeking an experienced Project Data Manager to oversee data management activities across multiple clinical projects. This role ensures quality and consistency while mentoring DM staff and managing vendor relationships. The ideal...SeniorFull time
- ...award-winning, data-focused clinical research organization (CRO)... ..., biotech, and medical device industries with our... ...scientific approach to complex trial data and regulatory submission challenges. With... ...only maintains an industry-leading customer satisfaction rating...SeniorRegulatoryRemote work
$65.25k - $169.4k
...Collaboration Partners (CP) within the Clinical Trial (CT) space. Working under... ...nude/unlabeled drug product.Lead and/or actively participate... ..., self-assessments, and regulatory inspections.Basic... ...experience in the pharmaceutical or medical device industry may substitute...SeniorRegulatoryCasual workWork at officeMonday to FridayFlexible hoursShift work$28 - $32 per hour
A leading agricultural chemical company is seeking a Regulatory Specialist - Scientific Writer in Indianapolis. The ideal candidate has a Bachelor’s degree in Chemistry or a related... ...of GLP standards is preferred. This is a senior-level contract position offering a...SeniorRegulatoryContract work- ....Labcorp is seeking a Senior Director, Precision MedicineBusiness... ...point across Clinical Trial Delivery, Companion... ...enabling functions.Lead and develop a high-performing... ...Finance, HR, Quality, Regulatory Affairs, Digital... ...comprehensive benefits including: Medical, Dental, Vision, Life,...SeniorRegulatoryTemporary workCasual workInternshipFlexible hours
- ...manage end-to-end payroll for a large, commission-based workforce across multiple states, with a heavy emphasis on accuracy and regulatory compliance. This role requires strong ADP Workforce Now skills and meticulous attention to detail. The ideal candidate brings 5+...SeniorRegulatoryLocal area
$120.2k - $140k
...environment? As an experienced Clinical Data AMS Senior Consultant you will... ...Analytics (CDA) AMS Lead will serve as the... ...of clinical and regulatory R&D platforms — including... ...Elluminate, Eclipse (medical coding), and EAST —... ...systems. Support EAST (Trial design and simulation...SeniorRegulatoryPermanent employmentLocal areaRemote workVisa sponsorship$156k - $228.8k
...Process OwnerClinical Trial FoundationsPurpose:Clinical Trial Foundations as... ...areas (e.g., Medical Quality, Ethics and... ...development partners to lead efforts to design, sustain... ...changing regulatory and industry landscape... ...peers, management and senior leadership Demonstrated...SeniorRegulatoryFlexible hours- ...Inc. (IHI) in Indianapolis is seeking a Medical Education Program Manager to build a sustainable... ...medical education infrastructure for clinical staff. You will develop orientation,... ...with leaders and SMEs to align with regulatory requirements. You will oversee module development...Regulatory
- ...precision, extensive GAAP knowledge, and strong business acumen to lead the accounting organization for multifamily properties. The VP... ...reports, and coordinate audits with external firms while maintaining internal controls and regulatory #J-18808-Ljbffr Sares Regis GroupSeniorRegulatory
- Hanson Professional Services, Inc. seeks an Air Quality Engineer to lead permitting projects and advise clients on compliance strategies... .... You will collaborate with multidisciplinary teams to ensure regulatory adherence and quality outcomes. Ideal candidates bring PE...SeniorRegulatory
- ACES seeks a Senior Reliability Compliance Specialist to oversee NERC O&P standards, support mock audits, and monitor regulatory changes. The role involves collaborating with internal teams to improve compliance processes, and travel to meet ACES members and stakeholders...SeniorRegulatory
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