Associate Director: Global Labeling & Disclosures
Sarepta Therapeutics
Sarepta Therapeutics in the United States is seeking an Associate Director, Labeling and Disclosures to lead global labeling for development and marketed products and to manage clinical trial disclosures with Health Authorities and public databases. You will partner with cross-functional teams, ensure regulatory integrity, and drive compliant labeling strategies worldwide while coordinating with vendors and internal stakeholders. #J-18808-Ljbffr Sarepta Therapeutics
$160.8k - $201k
...a full list of our comprehensive benefits, see our website: The Importance of the Role The Associate Director, Labeling and Disclosures, will be responsible for leading global labeling activities for development and/or marketed products, and leading disclosure activities...SuggestedFull timeWork at officeLocal areaImmediate startWorldwide$154.4k - $242.55k
...the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction...SuggestedMinimum wageTemporary workLocal area- Takeda's Plasma-Derived Therapies (PDT) R&D Organization in Cambridge, MA is seeking a Global Regulatory Labeling Strategy Lead (Associate Director) to steer labeling strategy across US and EU. You will work with Clinical, Pharmacovigilance, Legal, and Commercial teams...Suggested
$163.2k - $244.8k
Job DescriptionGeneral Summary:The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution... ...Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions to support...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$154.4k - $242.55k
.../ Purpose: Defines, develops and leads global strategies to maximize global regulatory... ...counterparts.Accountabilities:The Associate Director will be responsible for complex or highly... ...applicable sub-working groups, such as the Label Working Group, and represents GRTs at...SuggestedMinimum wageTemporary workLocal areaRemote work$152k - $209k
...pioneers in neuroscience. The role of the Associate Director requires the ability to provide... ...objectives. The role may also require review of global, corporate, clinical trial, and... ...materials are consistent with FDA-approved labeling, compliant with applicable FDA regulations...Temporary workWork at officeLocal area$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices. Here’...Permanent employmentWork at officeWork from home$142.5k - $256.5k
The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...Prescription Drug Promotion)/Advertising and Promotional Labeling Branch (APLB) guidance, and industry best practices. The...Work at officeWork from home$273.21k - $331.06k
...Associate Director, Global Clinical Physician, Neuroscience Working with Us Challenging. Meaningful. Life-changing. Those aren't words that... ...to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office...Hourly payFull timeTemporary workPart timeFor contractorsSummer workWork at officeRemote workWorldwideFlexible hours$183k - $252k
About the RoleThe Global Associate Medical Director, Evidence Generation and Education is a key member of the Global Medical Rare Disease team, reporting into the Rare Disease Global Medical Lead and supporting the Global Medical Directors, Rare Disease - ALS and SMA. This...Full timeTemporary workLocal areaWorldwide$169.4k - $266.2k
...Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Director, Global Scientific Communications Group Lead. This is a hybrid role based in Cambridge, MA.As a...Minimum wageTemporary workFor contractorsFreelanceLocal areaRemote work$194k - $267k
About This Role As the Associate Medical Director, Global Drug Safety, you will play a pivotal role in safeguarding patient well-being and shaping the safety strategy for both investigational and marketed products across our portfolio. In this highly visible position,...Full timeTemporary workLocal area- Job DescriptionThe Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management...Worldwide
$154.4k - $242.55k
...all information I submit in my employment application is true to the best of my knowledge.Job DescriptionLead, Global Pricing, Oncology (Associate Director)Takeda PharmaceuticalCambridge, MAAbout the role:This role will lead the development of global pricing strategies...Minimum wageTemporary workLocal areaRemote work$135k - $225k
...many ways we give back to our communities.What You Will Do:The Global Market Access team provides commercialization strategy and... ...access strategies across major and emerging global markets.Associate Directors are key members of the Global Market Access teams and contribute...Full timeWork experience placementImmediate startRemote workFlexible hours$154.4k - $242.55k
...we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery...Minimum wageTemporary workLocal areaRemote workWorldwide- ...compliant, cost-effective delivery of investigational products to global sites and partner with Clinical Operations, Quality, Regulatory... ...supply chain, with deep experience in global clinical trial supply, labeling, packaging, IRT/IXRS, and #J-18808-Ljbffr Korrobio
- Biogen is seeking a Global Associate Medical Director to lead evidence generation and education for SMA and ALS across the Rare Disease portfolio. You will translate complex real-world data into comprehensive medical education materials for Global Medical, regional medical...
$154.4k - $242.55k
...Job DescriptionAt Takeda, we are driven by our purpose: to create better health for people and a brighter future for the world. As a global, values-based biopharmaceutical leader, we put patients at the center of everything we do. Our mission is to discover and deliver...Minimum wageContract workTemporary workWork at officeLocal areaImmediate start$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence. Leading the charge in designing, implementing, and sustaining the enterprise Quality Risk Management (QRM) capabilities...Full timeTemporary workLocal area- Novartis Group of Companies in Cambridge, MA seeks an Associate Director to provide global, end-to-end nonclinical safety leadership across multiple therapeutic areas and modalities. You will serve as the PCS authority on cross-functional R&D teams and interactions with...
$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be required. We are partnered with a biotechnology organization that believes in the potential of engineered cells as medicine, and is composed of a team that wants to lead...Work experience placementRemote workWorldwideShift work$169.4k - $266.2k
...medical grants, medical education grants and sponsorships within Global Medical.Ensures that funding decisions are transparent,... ...program design, audience, budget, deliverables, outcomes plan, disclosure needs and potential risk indicators.Maintain governance visibility...Minimum wageTemporary workWork at officeLocal area- Firm Overview: Cambridge Associates (“CA”) is a leading global investment firm. CA’s goal is to help endowments & foundations, pension plans, and... ...Overview Cambridge Associates is seeking an Associate Director to support the Private Client Practice, with responsibility...Full timePrivate practiceWork at officeLocal areaWorldwide
$274.5k
Role Summary The Global Development Lead (GDL) represents Clinical... ...Development Plan and associated protocol design documents. The... ...activities including product labels, core data sheets, Investigator... ...support (DSUR, PBRER) submission disclosure deliverables and product defense...Permanent employmentFull timeH1bLocal areaWorldwideVisa sponsorshipWork visaRelocation package2 days per week- Associate Director, Global Regulatory Affairs, Advertising and Promotion Job Description At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. The Associate Director, Global...Full timeRemote workWorldwide
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure FDA and global promotional compliance across channels. You will serve as a liaison among Regulatory Affairs, Legal, Medical, and Commercial teams to align regulatory strategy...
- ...leading biotech company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs.... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and leadership...
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one... ...based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global regulatory lead...
$280k
Posting Description ASSOCIATE DIRECTOR, Global Investment Legal Services (GIS Legal), will focus on reviewing and negotiating investments in private funds, co-investment vehicles, operating companies, direct securities, and separately managed accounts; work closely with...Full timeWork at officeVisa sponsorship2 days per week
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