Director, Regulatory Tech & Medical Writing Systems
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals seeks a Director, Regulatory Technology & Medical Writing Systems to shape the technology strategy for Regulatory Affairs, Regulatory Operations, and Medical Writing. You will lead as the primary business technology functional leader, ensuring platforms, data, and workflows enable compliant, inspection-ready operations across the product lifecycle. The role requires experience shaping strategy with cross-functional partners (Technology, Data, Quality, Security) and #J-18808-Ljbffr Alnylam Pharmaceuticals
$187.4k - $253.6k
...Alnylam continues to expand its global development and regulatory footprint, Regulatory Sciences supports increasing... ..., compliance, and operational efficiency.The Director, Regulatory Technology & Medical Writing Systems will play a critical role in shaping and executing...MedicalFull timeTemporary workFlexible hours$215k - $230k
...Description About Spryte Medical At Spryte Medical, we're... ...experienced and strategic Director of Regulatory Affairs to lead the development... ...regulatory processes, systems, and procedures to support... ...Regulations. Strong regulatory writing, negotiation, and...MedicalFor contractorsLocal area- Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical... ...role is primarily responsible for coordinating regulatory medical writing across functions. The position works cross-functionally to...MedicalContract work
$220k - $249.71k
...importantly, while experience within a Regulatory Writing department at a growing biotech is beneficial... ...is a dynamic, growing team. The Director of Regulatory Writing will coordinate and... ...responsibility as a regulatory / medical writer; education in a scientific field...MedicalWork at office$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical... ...in verbal presentations and in writing regulatory strategy plans and submission... ...their growth and aspirations. From medical, dental and vision benefits to...MedicalFull timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week- Job title: Senior Manager Regulatory Affairs Advertising and Promotion... ...understanding of the immune system - and innovative pipeline - enables... ...(RC) for commercial and medical materials, respectively.... ...solid oral communication and writing skills. Understanding of the...MedicalWork experience placement
$89k - $119k
About SimpliSafeWe’re a high-tech home security company that’s passionate... ...Manager, you'll own billing system operations and drive ongoing... ...recommendations.Skilled in writing functional requirements and... ...in addition to a full range of medical, retirement, and lifestyle benefits...MedicalWork at office- CAMP4 Therapeutics in Watertown, MA is seeking an Associate Director or Director of Medical Writing to lead creation and review of clinical and regulatory documents, and guide regulatory strategy. The role also involves mentoring junior writers and collaborating across...Medical
$215k - $235k
...then please read on!About the Role:The Director of Regulatory Affairs is responsible for leading... ...clinical stages. Reporting to the Chief Medical Officer, this role serves as the Global... ...interactions.Oversee and coordinate medical writing support and submission vendors for...Medical- ...following: operating model strategy, M&A, tech value and cost take-out, or technology... ...growth strategy.Minimum 5 years of experience writing business cases.Minimum 2 years of... ...competitive suite of benefits including medical, dental, vision, life, and long-term disability...MedicalFull timeLive inWork at officeLocal area
$177k - $278.08k
...patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you... ...minimizing the risk of write-offs.Responsible for... ...including clinical, safety, medical affairs, and commercial, to... ...principles and regulatory/quality systems relevant to drug...MedicalMinimum wageLocal areaRemote workWorldwide$210k - $320k
...patients suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for... ...manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions.Experience...Full timeShift work3 days per week1 day per week$182k - $275k
...high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s)... ...processes, templates, SOPs, and systems that support efficient and compliant document... ...diseases and/or conditions with high unmet medical need is preferred. Experience...MedicalWork at office- ...position in audience reach, usage and ad tech with powerful tools and insights for our... ...paced environmentsExcellent storytelling, writing skills, and presentation skills.Experience... ...the following:Employer sponsored medical, dental and vision with a variety of coverage...MedicalFull timeWork at officeRemote workFlexible hours
- ...Sr. Manager, Communications, Media & High-Tech IndustryTechnology Strategy, and we... ...growth strategy.Minimum 5 years of experience writing business cases.Minimum 2 years of experience... ...competitive suite of benefits including medical, dental, vision, life, and long-term...MedicalFull timeLive inWork at officeLocal area
$177k - $278.08k
...Description Objective / Purpose: The Director, Innovation leads the GRIDS Innovation... ...improvement initiatives across Global Regulatory Affairs. This role ensures that innovation... ...both rapid improvements and strategic system advancements aligned with GRA and...Minimum wageFull timeInterim roleLocal area$120.8k - $181.2k
...patients first — developing innovative medical technologies that improve the lives of 7... ...impact. A Day in the Life As the Regulatory Affairs Manager, you will be responsible... ...Monitor and improve tracking and control systems. Keeps abreast of regulatory procedures...MedicalFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$133k - $186k
...roles, access to market leading medical and emotional and mental... ...historical data, dashboards, and tech tools to predict schedule risks... ...the integration of scheduling systems with advanced cost estimating... ...of a keyboard, telephone, or writing. The employee is frequently required...MedicalTemporary workFor contractorsWork at office$170k - $267.5k
...experience integrating new products and/or systems required. Applicants should be at ease... ...to implement the solution (bring to life)Writing and presenting business cases that are supportable... ...locations, but you may expect generous medical care, insurance and savings plans among...MedicalFull timeTemporary workFlexible hours$170k - $267.5k
...Product Strategy - Managing Director Qualified applicants should... ...integrating new products and/or systems required. Applicants should... ...solution (bring to life). Writing and presenting business cases... ...but you may expect generous medical care, insurance and savings plans...MedicalTemporary workFlexible hours$151k - $222.1k
...contract, to how it is configured in our systems, to the charge a merchant sees. We are... ...External Audit. You will report to the Director, Sales Compliance. [Work model — e.g., hybrid... ...Workplaces Act). DoorDash also offers medical, dental, and vision benefits, 11 paid...MedicalHourly payContract workWork at officeLocal areaRemote workFlexible hours- ...Denmark Reporting to : VP, Regulatory Affairs & Quality... ...Denmark. The role As Director, Regulatory Affairs,... ...clinical, CMC, nonclinical, medical and other functions so... .... The ability to write and review high-... ...of its own structure. Systems get created as we need...MedicalRemote work
$210k - $245k
...the power of the human immune system to develop transformative... ...designed to selectively expand regulatory T cells and reset the immune... ...Medicines is seeking an experienced Director of Regulatory Affairs to... ...motivate top talent, including medical, dental, vision, and life...MedicalTemporary workWork experience placementWork at officeFlexible hours3 days per week$90k - $200k
...complex investigations, forensic accounting, regulatory compliance, including business... ...and initiative in developing leads and writing proposalsAssist in selling and winning new... ...include:Healthcare Coverage: Comprehensive medical, dental, and vision plans.Time Off and Leave...MedicalTemporary work$120k - $217.5k
...information requests, regulatory and audit response, senior... ...to the Managing Director, Cyber Product, Platforms... ...in structured writing, data storytelling and... ...Business, Information Systems, Computer Science, or... ...including basic life, medical, dental, vision, long-...MedicalFull timeTemporary workFlexible hoursShift work$124k - $280k
...optimising algorithms, models, and systems to enable intelligent... ...architecture strategies. As a Director, you drive thought leadership... ...SQL and relational databases- Writing and maintaining FastAPI endpoints... ...range of benefits, including medical, dental, vision, 401k,...MedicalFull timeH1b$186.23k - $279.35k
...Seaport, Boston Reports to: Senior Director, Global Regulatory Strategy About Alexion For over... ...with rare diseases and unmet medical needs. This individual will provide... ...working in a regulatory documentation system (like Veeva). Proficient in English...MedicalTemporary workWork at office- ...Takeda Cambridge seeks a Director, Business System Owner – Veeva RIM to define and deliver the technology strategy and roadmap for Takeda’s Veeva RIM platform, ensuring alignment with regulatory priorities and data governance. You will lead cross-functional teams, drive...
- ...their goals.Job DescriptionReporting to the Director of the Office for Community Support, Non... ...legal research, analytical, and writing skills. Strong organizational skills and... ...paid time off including parental leave Medical, dental, and vision health insurance coverage...MedicalWork at officeLocal area
$170k - $180k
Manager, Tech Strategy Advice - Healthcare & Life Sciences - ElevateIn the United States... ..., including pharmaceuticals & biotech, medical technology, diagnostics, digital health &... ...commercial, analytics, and IT strategies; design system architecture; and optimize clients’...MedicalFull timeWork experience placementWork at officeWork from homeFlexible hours2 days per week3 days per week
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