Senior Director, Global Clinical Operations and Medical Writing Technology
Vertex Pharmaceuticals Inc (US)
Overview Senior Director, Global Clinical Operations and Medical Writing Technology will lead a team responsible for planning, architecture, design, development, support, maintenance and future roadmaps for systems supporting clinical operations and medical writing teams. The role collaborates with senior leaders and stakeholders across Global Clinical Operations, Medical Writing, and the Data, Technology and Engineering organization to identify, prioritize, design and deliver digital and AI solutions in support of business goals. Responsibilities Partner with business stakeholders across Global Clinical Operations and Medical Writing to manage and prioritize the digital and AI technology portfolio and continually build the future roadmap. Build and strengthen relationships with key stakeholders to become a trusted partner and contribute toward strategic business goals. Present ideas and forward-looking plans to cross-functional senior leaders on a regular basis. Develop multi-year leadership-driven technology roadmaps delivering valued outcomes. Direct and lead a group of team members (including a managed services team of support engineers, administrators, and analysts). Oversee a portfolio of projects, programs, releases and system enhancements, ensuring quality and timely delivery within budget. Proactively offer innovative tools/technologies, AI solution ideas, and business process improvements to drive efficiencies and meet business needs. Enhance internal processes for demand management, resource management, project delivery, platform releases and ongoing operational support. Manage relationships with strategic software vendors and service providers. Provide day-to-day support and maintenance for critical applications such as Veeva Vault CTMS, Veeva eTMF, and Elluminate EDC, ensuring maximum uptime and high performance. Collaborate with Information Security and Quality Assurance to ensure compliance with GxP regulations and lifecycle/change management requirements. Knowledge and Skills Direct experience with biotechnology and/or pharmaceutical systems, particularly in clinical operations and medical writing. Hands-on expertise in identifying AI opportunities, deploying Agentic/Gen AI solutions, and leading organizational change management and training for business partners. In-depth knowledge of the biotech industry and regulations such as 21 CFR Part 11 and Good Clinical Practices (GxP). Program/project management, demand management, resource management and system lifecycle expertise. Strong communication, interpersonal and collaborative skills; solid analytical and problem-solving abilities. Excellent verbal, written, and presentation skills to influence technical and non-technical audiences. Education and Experience Bachelor’s degree with 10+ years of relevant work experience; biotech or pharmaceutical industry experience. Experience managing implementation partners and managed services/offshore teams. Deep experience with enterprise applications and SaaS implementations, upgrades, enhancements and operational support. Experience in design, development, and deployment of technology solutions using agile software development practices. IT financial management experience, managing budgets and forecasts across operating expenses and new investments. Note: The following compensation and benefits information is provided for transparency in the posting and may be subject to change. This role is eligible for an annual bonus and equity awards. Total rewards include medical, dental, vision benefits, paid time off, educational assistance, commuter subsidies, 401(k) and other programs where applicable. Flex designation: Hybrid-Eligible or On-Site Eligible. Details subject to Vertex policy. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for serious diseases. Vertex is an equal opportunity employer. We value diverse perspectives and backgrounds. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)
- he Senior Director, Global Clinical Operations and Medical Writing **Key Duties and Responsibilities:** Work closely with Information Security and Quality Assurance... ...in design, development, and deployment of technology solutions using agile software development practices...OperationsSeniorMedicalWork experience placementSummer workRemote work2 days per week
$173.39k - $210.11k
Senior Manager, Global Clinical Science - Neuroscience Data Privacy Position Summary Responsible for design... ...study design, statistics, clinical operations Understand assigned protocol(s) and... ...trend identification Intermediate medical writing skills and medical terminology...OperationsSeniorMedicalTemporary workSummer workFlexible hoursShift work$173.39k - $210.11k
## Senior Manager, Global Clinical Science, NeuroscienceCambridge Crossing - MA - USFind out how well... ...study design, statistics, clinical operations* Ability to understand assigned protocol... ...trend identification* Intermediate medical writing skills and medical terminology*...OperationsSeniorMedicalHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- Vertex Pharmaceuticals seeks a Senior Director of Global Clinical Operations and Medical Writing based in Boston, Massachusetts. This role requires extensive experience in biotechnology and pharmaceutical systems, focusing on compliance with GxP regulations and management...OperationsMedicalRemote work2 days per week
$229.67k - $278.31k
## Senior Dir, In-Vivo & Non-Clinical PharmacologyCambridge Crossing... ...as the Senior Director for In-Vivo &... ...underlying scientific operations themselves. In... ...Insights & Technology, this leader... ...navigating matrixed, global organizations*... ...Coverage:** Medical, pharmacy,...OperationsSeniorMedicalHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Summary The Senior Director of Clinical Operations oversees all aspects of clinical... ...through close out and CSR writing, including site and vendor... ...the CMO to develop the global clinical operations budget... ...by unique Pb-212 isotope technology and seamless supply. Our...OperationsSeniorContract workRemote work
$284.32k - $355.4k
...Pharma Co., Ltd., is a global pharmaceutical... ...based in Japan with operations in the U.S. (Sumitomo... ...the position of Senior Medical Director, Clinical Research (Neurology... ...trial results and the writing of clinical study... ...future with cutting edge technology and ideas...OperationsSeniorMedicalWorldwideFlexible hours$249.97k - $388.13k
...seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience... ...highest standards of scientific and medical integrity. The incumbent will be responsible... ..., data management, medical writing). • An advanced understanding of clinical...SeniorMedicalTemporary workLocal areaFlexible hours- Position Summary The Associate Director, Global Clinical Science reports through the... ...in collaboration with Medical Monitor/Clinical Development... ...minimal guidance, including writing, reviewing, resolving cross... ..., statistics, and clinical operations Proficient knowledge and...OperationsMedicalFlexible hoursShift work
$211.91k - $256.79k
...Associate Director, Global Clinical Science, Neuroscience Working with Us Challenging... ...(collaboration with Medical Monitor/Clinical... ...minimal guidance; including writing, reviewing, adjudication/resolution... ...design, statistics, clinical operations ~ Proficient knowledge...OperationsMedicalHourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workFlexible hoursShift work$230k - $330k
...Senior Medical Director, Clinical Development Watertown, MA Patients with adenoid cystic carcinoma... ...and assess SAEs, including narrative writing, causality assessment, and reconciliation... ...Collaborate with Clinical Operations on site selection, patient recruitment...OperationsSeniorMedical$288.2k - $360.2k
...Pharma Co., Ltd., is a global pharmaceutical... ...based in Japan with operations in the U.S. (Sumitomo... ...Risk Management (PVRM) Senior Medical Director will be responsible... ...medical safety aspects of clinical trials including... ...the future with cutting edge technology and ideasOperationsSeniorMedicalWork at officeLocal areaRemote workWorldwideFlexible hours- Medical Director/Senior Medical Director Full-time Be part of our... ...Director and member of our Clinical Development team, you... ...conjugates (ADCs) global clinical trials. You... .../PV/Clinical operations etc. Execute the clinical... ...trials. Experience writing protocol amendments,...OperationsSeniorMedicalOdd jobFull timeRemote workRelocation
- ...Clinical Study Manager A Few Words... ...: Information Technology (IT), Clinical... ...according to global regulatory requirements... ...to Clinical Operations regions. 4.... ...lock, writing the Clinical Study... ...9. Escalates medical issues to appropriate... ...and Associate Director, Clinical...OperationsMedicalContract work
$275k - $327k
...Sr. Director - Clinical Trials, Clinical Development... ...Development is a senior, highly visible and... ...end execution of global interventional studies... ...and operational feasibility. Serve... ...Operations, Payers, Medical Affairs, and other... ...Clinical protocol writing and review (...OperationsSeniorMedical$145k - $215k
...we are Kymera is a clinical-stage... ...collaboration with Clinical Operations, ensuring alignment... ...safety. Perform medical data monitoring, including... ...with medical directors, regulatory... ...with experience in global clinical trials and... ...excellent medical writing skills. Equal Employment...OperationsSeniorMedical- ...with cutting-edge technologies to create innovative... ...seeking a Senior Manager to join our... ...where to locate and operate, choice of entity,... ...mobilize capital to fund global operations, taking... ...research and writing, Excel modeling, and... ...a variety of medical and dental plans,...OperationsSeniorMedicalTemporary workLocal area
$90k - $100k
...across a variety of medical communication... ...management, to join us as Senior Medical Writers in... ..., scientific writing and contributing to... ...of our existing operations in the UK and Asia... ...colleagues in the US and globally. Hybrid Working... ...and medical technology companies in the industry...OperationsSeniorMedicalPermanent employmentFull timeTemporary workWork at officeImmediate startWork from homeFlexible hours$104k - $156k
Senior Analyst, Intelligent Automation... ...Vertex is a global biotechnology... ...The Digital, Technology and Engineering... ...Research, Pre-Clinical, Manufacturing... ..., and improve operational efficiency and... ...aspirations. From medical, dental and... ..., Writing Skills #J-188...OperationsSeniorMedicalSummer workRemote workFlexible hours2 days per week- Vertex Pharmaceuticals Inc (US) is looking for a Senior Director, Global Clinical Operations and Medical Writing Technology. This role involves leading a team focused on planning, design, and development for systems that support clinical operations. The candidate will...OperationsMedical
$130.4k - $163k
...Co., Ltd., is a global pharmaceutical company... ...in Japan with operations in the U.S. (... ...to the Executive Director, Clinical Data Management,... ..., Biostatistics, Medical Monitoring, Safety... ...Operations, Medical Writing, Medical Monitoring... ...cutting edge technology and ideas...OperationsMedicalWork at officeRemote workWorldwideFlexible hours- The Senior Employer Branding Manager is responsible... ...calendar, writing, editing, and... ...Partner with People Operations, Marketing, and... ...trends, tools, and technologies to keep... ...Stock Units (RSUs) Medical, Dental, Vision,... ...MA, CMT operates globally with offices in Budapest...OperationsSeniorMedicalTemporary workSummer workFreelanceWork from homeWorldwideFlexible hours
- ...organization who are seeking to appoint a Senior Medical Director, Clinical Development to play a key leadership... ...indications. Serve as Global Clinical Lead for one or more programs... ...groups . Collaborate with Clinical Operations to ensure timely, high‑quality...OperationsSeniorMedical
$94k - $124k
...motivated and creative Senior Actuarial Analyst. The... ...ideas into current operations. Responsibilities Utilize... ...effectively in writing and verbally, to support... ...that start on Day 1 (medical, dental, vision) Robust... ...continuously invest in technology, our employees thrive...OperationsSeniorMedicalWork experience placement$310k - $365.8k
...owned and independently operated subsidiary of Bayer AG... ..., we are building the clinical infrastructure to... ...directly to the Chief Medical Officer and embedded within... ...The title and level (Senior Director or VP) will be... ...operations • Ensure global safety reporting compliance...OperationsSeniorMedical- ...Job Title PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our...OperationsSeniorMedicalWork experience placement
- Senior Evidence to Scale Manager - J-PAL Global The Abdul Latif Jameel Poverty Action... ...Institute of Technology (MIT) in 2003 and... ...scale, training, and operations staff across Africa... ...closely with the E2S Director (also J-PAL’s... ...communicate clearly in writing and orally with...OperationsSeniorWork experience placementWork at officeLocal areaVisa sponsorshipFlexible hours2 days per week
- ...toolbox of cutting‑edge technologies, and a team of... ...Odyssey is seeking a Senior Clinical Data Manager to own clinical... .... Reporting to the Director of Clinical Data... ...closely with clinical operations, biostatistics, statistical... ...pharmacovigilance, medical monitoring,...OperationsSeniorMedical
$200k - $270k
...Clinical Operations Professional Ovid Therapeutics Inc. is a New York... ...monitors, biostatistics, medical writing, safety and other key stakeholders... ...product development; global experience highly... ...the function to advance new technologies in new therapies. Must be...OperationsSeniorMedicalWork at officeLocal areaWorldwideFlexible hours$315k - $354k
...communities we serve. We are a clinical-stage company currently... ...Opportunity Amylyx is seeking a Senior Medical Director, Clinical Development to... ...Affairs, Clinical Operations, and Commercial to ensure that... ...representative, engaging with global medical experts,...OperationsSeniorMedicalLocal areaRemote work
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