Clinical Regulatory Writer - Associate Director/Manager
AstraZeneca
AstraZeneca is looking for a Clinical Regulatory Writer at the Associate Director or Manager level in Boston, MA. This hybrid role involves managing regulatory writing activities, authoring significant clinical documents, and providing strategic communications leadership. Qualified candidates should have a BS in Life Sciences with significant medical writing experience in the pharmaceutical sector. The position offers a competitive salary and various benefits including healthcare coverage and retirement programs. #J-18808-Ljbffr AstraZeneca
$133.04k - $199.56k
Job Title: Clinical Regulatory Writer, Associate Director or Manager Location: Boston, MA - Hybrid (3 days onsite) Are you ready to be part of the solution, turning drug development strategies into reality? As a Clinical Regulatory Writer, you will play a pivotal role in...SuggestedTemporary work3 days per week- ...The Clinical Regulatory Writing team provides expert communications leadership... ...The Clinical Regulatory Writing Associate Director is expected to: Independently manage clinical regulatory writing activities... ...with vendor medical writers to ensure delivery to time and...Suggested
$154.4k - $242.55k
...global strategies to maximize global regulatory success towards achievement of program... ...counterparts. Accountabilities: The Associate Director will be responsible for complex or... ...Ensures project team colleagues, line management, and key stakeholders are apprised of...SuggestedMinimum wageFull timeTemporary workLocal areaRemote work$193.18k - $236.1k
...How You Will Achieve More: The Associate Director, Regulatory Affairs Advertising, Promotion & Labeling... ...promotional claims and campaigns Manages the FDA 2253 program, leading... ...a plus ~ BS degree in scientific, clinical or related area required. Advanced degree...SuggestedWork at officeRemote work- ...Associate Director or Director, Regulatory Affairs (Hybrid 3 days in office) How you'll make an impact: The Associate Director or Director of Regulatory Affairs will be a key member of the STAT6 Regulatory team working in partnership with the Global Program Regulatory...SuggestedWork at office
$171k - $204k
...happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to... ...medicines. The Opportunity The Regulatory Affairs team at Entrada is a dynamic, growing team. The Associate Director will support global regulatory activities for...Work at officeLocal areaRemote work$154.4k - $242.55k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...and Commercial project teams throughout clinical development and commercial lifecycle.... ..., develops, plans, executes and manages regulatory submissions per the GRA CMC Product...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide- ...Associate Director, Global Regulatory Affairs We are seeking an experienced Associate Director for our Global Regulatory Affairs team within our... ...Reviewing archived regulatory applications and assessing any clinical hold issues Coordinating and submitting requests for...Work at officeFlexible hours
$154.4k - $242.55k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing &... ...and Commercial project teams throughout clinical development and commercial lifecycle.... ..., develops, plans, executes and manages regulatory submissions per the GRA CMC Product...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Associate Director, Global Regulatory Affairs, Advertising and PromotionJob DescriptionAt Takeda, we are a... ...&P) Review Lead is accountable for management of all assigned programs/products as... ...a strategic business partner from clinical trial development through the marketing...Full timeRemote workWorldwide
- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies... ...the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP...
$154.4k - $242.55k
...bring life-changing therapies to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute... ...needs. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide$160k - $240k
...Overview Rhythm Pharmaceuticals is seeking an exceptional Global Regulatory Lead who embodies our organizational values and thrives in a... ...Plans, responses to agency questions, and more) Manage regulatory timelines and ensure all commitments are met with excellence...Work at officeShift work- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid... ...late stage. Prepare, author, and manage regulatory submissions including INDs... ...multidisciplinary teams including CMC, clinical, and nonclinical functions....Permanent employmentFull time
$187.4k - $281.2k
...strategy. Maintain high-level industry, regulatory, clinical, and scientific knowledge. Knowledge &... ...and ethical aspects of a medical director role. Ability to anticipate issues and... ...experience and 2 years of supervisory/management experience (or equivalent education/experience...Local areaRemote workFlexible hours2 days per week3 days per week- ...Contractor, Sr. Manager/Associate Director, Regulatory Affairs Our Waltham based client is looking for an experienced Regulatory Affairs professional to lead U.S. regulatory strategy and serve as a key liaison with the FDA. In this role, you’ll guide development programs...For contractors2 days per week
$172k - $187k
...Job Description Regulatory Affairs Chemistry, Manufacturing... ...are seeking an experienced Associate Director, Regulatory Affairs CMC to... ...strategic regulatory direction and managing CMC related activities in... ..., and a pipeline of clinical and preclinical candidates...Work at officeLocal area- ...Associate Director Of Regulatory Affairs Cmc Hybrid role. The associate director of regulatory affairs cmc will support development cmc team... ...inquiries from regulatory agencies with thorough submission management Support preparation for health authority cmc meetings...
- ...targets. Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will... ...combine knowledge of scientific, clinical, regulatory, and business to lead... ...Ensure project team colleagues, line management, and key stakeholders are apprised...Temporary workWork at officeLocal areaImmediate start3 days per week
$140k - $160k
...Associate Director of Global Sourcing Location: Newton, MA (4 days on site) We have partnered with a rapidly growing consumer products... ...Lead supplier negotiations, RFP processes, and contract management initiatives. Partner cross-functionally to support innovation...Contract work$130k - $170k
...ASSOCIATE DIRECTOR, PRIVATE WEALTH As a Senior Recruiter at Fanning- Masis, I assist my client companies, investment/asset/wealth management firms located in and around Boston which serve a private wealth and/or institutional client base, with their candidate recruitment...- ...innovation‑driven biopharma organization is seeking an Associate Director–level Biostatistics position to guide statistical... ...visible, cross‑functional leadership role supporting clinical development, regulatory strategy, and scientific decision‑making for a program...Worldwide
$169.4k - $266.2k
...with the healthcare community. As an Associate Director, Scientific Training, Global Medical Affairs... ...with cross-function teams Vendor management experience Strong communication,... ...Experience in Medical Affairs or Clinical Development, and in adult education, is...Minimum wageFull timeTemporary workLocal areaWorldwide$198.09k - $242.11k
...exciting opportunity for an energetic, passionate, and accomplished Associate Director of Solution Architecture. This is a critical, hands-on... ...our Boston, MA office. Your Day to Day Lead, mentor, and manage a team of high-performing solution architects, fostering...Work at officeLocal areaFlexible hoursShift work$100k - $190k
...Associate Director, Tax Services - Hedge Funds The Tax Department leads the Company's day-to-day tax operations, including the filing of... ...teams design, implement, and operate solutions that help clients manage data, automate processes, and scale their businesses with...Ongoing contractLocal area$162.45k - $213.22k
...Hi, we're Oscar. We're hiring an Associate Director, Tax to join our Finance. Oscar is the first health insurance company built around a... ...and annual performance bonuses. Responsibilities: Manage the annual and quarterly tax GAAP and Statutory tax provision...Full timeWork at officeLocal areaRemote work$169.4k - $266.2k
...you to shine? Join us as an Associate Director, Medical Review. This is a... ...Medical Team(s), Brand Team(s), Regulatory Advertising and Promotion,... ..., review, and approval of clinical data on file to support... ...healthcare or related experience (managed markets, clinical practice,...Minimum wageTemporary workWork at officeLocal areaRemote workNight shift$156.4k - $195.5k
Foundation Medicine, Inc. in Cambridge, MA, is seeking an Associate Director of BioPharma Business Development. This role is pivotal in fostering strategic partnerships within the Biopharma sector, focusing on Oncology. Candidates should possess over 10 years of business...Remote work$155k - $200k
...underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform... ...age, marital status, veteran status, or disability status.The **Associate Principal Scientist, PharmaR&D** will design, propose and...Work experience placementShift work- **Job Title:** Associate Director, Medical Value and Outcomes (Mid-Atlantic)**Location**: Remote... ...scientific exchange on disease state management and the value of Sanofi Genzyme products... ...health economic information (e.g., clinical presentations, dossier, budget impact...Temporary workLocal areaRemote work
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