Senior Director, Global Clinical Operations and Medical Writing Technology
Vertex Pharmaceuticals
Job DescriptionGeneral Summary:The 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 at Vertex. The incumbent will collaborate with senior leaders and other key stakeholders across these areas of the business, as well as peers across the Data, Technology and Engineering (DTE) organization, to identify, prioritize, design and deliver digital and Artificial Intelligence (AI) solutions in support of their goals and objectives. Key Duties and Responsibilities: Partner with business stakeholders across Global Clinical Operations and Medical Writing teams to manage and prioritize the digital and AI technology portfolio and continually build the future roadmap Build and strengthen relationships with key stakeholders - become a trusted partner and have an ongoing, significant impact towards meeting strategic business goals Present ideas and forward-looking plans to, and engage directly with, cross-functional senior leaders on regular basis Develop multi-year leadership-driven technology roadmaps delivering valued outcomes Direct and lead a group of 5 Vertex team members, plus a managed services team of support engineers, administrators, and analysts Oversee a portfolio of projects, programs, releases and system enhancements, assuring quality and timeliness of delivery while remaining within allocated budget limits Proactively offer innovative new tools/technologies for consideration, AI solution ideas, and potential business process improvements in pursuit of driving efficiencies and meeting business needs Enhance and improve internal processes and procedures related to demand management, resource management, project delivery, platform releases and ongoing operational support Manage relationships with our strategic software vendors and service providers Provide day-to-day support and maintenance for business-critical applications such as Veeva Vault Clinical Trial Management System (CTMS), Veeva Electronic Trial Master File (eTMF), and Elluminate Electronic Data Capture (EDC) platform, ensuring maximum uptime, high performance, and excellent customer service Work closely with Information Security and Quality Assurance groups as needed to ensure compliance with GxP regulations, as well as our DTE system lifecycle and change management requirements Knowledge and Skills: Direct experience with biotechnology and/or pharmaceutical systems, particularly in the areas of clinical operations and medical writing Hands-on expertise with identifying AI opportunities, deploying Agentic/Gen AI solutions, and leading/supporting AI focused organizational change management and training for business partners In-depth knowledge of the biotech industry, including specific regulations such as 21 CFR Part 11 and Good Clinical Practices (or other GxP areas) Program/ project management, demand management, resource management and system life cycle 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 and 10+ years 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 procedures In-depth experience in design, development, and deployment of technology solutions using agile software development practices IT financial management experience, managing budgets and forecasts across operational expenses and new investments #LI-EE1 Pay Range:$256,000 - $384,000Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io: Boston, MAType: Full time
$210.9k - $379.2k
...drug developer lead Clinical Development for... ...will have direct medical responsibility for... ...clinical studies, writing protocols, ensuring... ...Biostatistics, Clinical Operations, Regulatory,... ...days, sabbatical, global recharge days, and... ...the leading mRNA technology platform, the infrastructure...OperationsSeniorMedicalPermanent employmentFull timeWork at officeWork from home$310k - $328.5k
## Senior Medical Director, Clinical SafetyApplyremote type: OnSitelocations: MA-Cambridgetime... ...-owned and independently operated subsidiary of Bayer AG, is... ...pluripotent stem cell technology and gene editing to... ...for PV operations* Ensure global safety reporting compliance...OperationsSeniorMedicalWorldwide- ...Description Summary The Senior Director of Clinical Operations oversees all aspects of... ...close out and CSR writing, including site and vendor... ...with the CMO to develop the global clinical operations... ...by unique Pb-212 isotope technology and seamless supply. Our...OperationsSeniorContract workRemote work
- Job Title: Global Development Senior Medical Director, Hematology OncologyHybrid Working: In the office a minimum... ...) to help address unmet clinical needs in a host of hematological cancers... ...share responsibility with Clinical Operations team members in the planning, execution...OperationsSeniorMedicalHourly payFull timeTemporary workWork at officeLocal areaWorldwide
$210.9k - $379.2k
...medicine through mRNA technology, with a diverse... ...worldwide, contributing to global health initiatives.... ...is seeking a Global Medical Director to lead medical affairs... ...extensively with regulatory, clinical, commercial, and... ..., clinical operations, and regulatory affairsStrategic...OperationsSeniorMedicalPermanent employmentFull timeWork at officeWork from homeWorldwide$80k - $150k
...all segments of the global capital markets.... ...About the RoleTITLE: Senior Systems AnalystTEAM: Post-Trade Technologies TeamLOCATION:... ...Coordination and Trade Operations teams to process... ...needsExperience writing requirements, functional... ...or mental), medical condition, citizenship...OperationsSeniorMedicalFull timeRemote workFlexible hours1 day per week$120k - $200k
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...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$156.78k - $250.85k
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...Boston, Massachusetts.Summary The Senior Director, Clinical Development will provide medical and scientific leadership for... ...compliance with project plans, global regulations, ICH/GCP guidelines,... ...evaluationPartner closely with Clinical Operations, Clinical Pharmacology,...OperationsSeniorMedical- ...to apply for the Senior Product Analyst role... ...regulators in writing and verbally, to support... ...start on Day 1 (medical, dental, vision)... ...continuously invest in technology, our employees... ...- Pricing, Amazon Global Logistics Boston,... ...Manager, Real-Time Operations We’re unlocking community...OperationsSeniorMedicalFull time
$130k - $190k
...suite of gene editing technologies is anchored by base... ...motivated and experienced Clinical Data Management... ...portfolio.Reporting to the Senior Director of Data Management,... ...with Clinical Operations, Biostatistics, Statistical Programming, Medical, Regulatory, and external...OperationsSeniorMedicalFull timeInterim role$259.3k - $350.8k
...physician drug developer in Clinical Research - Cardiovascular &... ...CVM therapeutic area. The Sr. Medical Director, Clinical Research is... ...programs and to drive progress and operational excellence for the... ...in effectively leading x-EA global clinical team (or CDST equivalent...OperationsSeniorMedicalFull timeTemporary workLocal areaFlexible hours$305.7k - $413.7k
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...The Sr Manager Case Management, Clinical Trial Safety will be... ...Sr Manager will report to the Director of Clinical Trial Safety Operations within the Global Case Management function of Safety & Regulatory Operations, Medical Writing and Benefit Risk Management (SABR...OperationsSeniorMedicalFull timeTemporary workLocal area$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$185k - $250k
...Medicines is seeking two experienced Clinical Operations leaders, at the Director or Senior Director level, to drive the... ...accountability while ensuring compliance with global regulatory standards. The ideal... .... Benefits Health Care Plan (Medical, Dental & Vision) Retirement Plan...OperationsSeniorMedicalTemporary workWork experience placementWork at office2 days per week$175k - $195k
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...Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes GLP/GCP/GVP quality... ...compliance across global clinical trials.... ...Clinical Operations, Medical Affairs,... ...industry standard technology platforms, across all...OperationsSeniorMedicalLocal areaWorldwide- ...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
$190k - $200k
Position Title: Senior Director, Global Physical Security TechnologyLocation -... ..., Global Physical Security Technology acts as a strategic advisor... ...technology strategy, systems, and operations, driving transformation and... ...role, Benefits include medical, dental, vision, life and...OperationsSeniorMedicalFull timeFor contractors$144k - $167k
...$144,000.00 To $167,000.00 Annually 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...OperationsSeniorMedicalWork experience placement- GlycoEra is a clinical‑stage biopharmaceutical company based... ...match our ambition. The Senior Director, Clinical Operations will provide strategic and... ...pipeline. Reporting to the Chief Medical Officer, he/she will lead... ...scale a high‑performing global clinical operations...OperationsSeniorMedicalFor contractors
$133.1k - $295.67k
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$153.43k - $332.7k
...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,...OperationsSeniorMedicalFull timeTemporary workLocal area$100k - $175k
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