Asset Protection Investigator Stellenangebote

Job vor 6 Tagen bei NewScientist Jobs gefunden Gilead Sciences, Inc.

Senior Manager, Global Regulatory Affairs, Precision Medicine

• Cambridge, United Kingdom, Cambridgeshire [...] health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead, we re creating a healthier world for all people. For more than 35 years, we ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer-working relentlessly [...] of diagnostics used in therapeutic trials with global and local regulatory requirements (such as US FDA and EU IVDR) . Support preparation and filing of IVD Performance Study applications, SRD IDE applications, HA briefing books, clinical protocols, study reports, ICFs, Investigator Brochures, IND applications, CTAs, BLAs, NDAs, PMAs, and labeling documents for drug and diagnostic products, in collaboration with Gilead internal functions, IVD partners and CROs. Contributes to Dx Regulatory QMS process improvements related to investigational devices which may have a significant impact on business. Support training related to the IVD/ CDx medical devices broader Precision Medicine initiatives. Ensures compliance with established practices, policies, pro cesses, and any applicable regulatory requirements. Basic Qualifications: Bachelor s Degree and extensive experience OR Masters Degree and extensive experience Preferred Qualifications: PharmD/ MS with relevant experience. BA/ BS with relevant experience. Significant Regulatory, Quality, compliance or related experience supporting development of investigational IVD devices in a biopharma setting. Experience with immuno-and molecular diagnostics technologies. Experience [...] (i. e. without regard to protected characteristics or prohibited grounds, which may include an individual s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws) . Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. 43002492 [...]
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Job vor 11 Tagen bei NewScientist Jobs gefunden Gilead Sciences, Inc.

Senior Manager, Medical Writing Oncology

• Uxbridge, United Kingdom, London (Greater) [...] health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we re looking for the next wave of passionate and ambitious [...] or supervise direct reports and contractors to ensure highest quality of medical writing and adherence to Gilead documents standards. EXAMPLE RESPONSIBILITIES: Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases, investigator s brochures, CTD summaries/ overviews, PIPs/ PIP modifications, and regulatory responses) . May represent Medical Writing in cross-functional teams, such [...] (i. e. without regard to protected characteristics or prohibited grounds, which may include an individual s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws) . Gilead also prohibits discrimination based on any [...]

Job am 31.03.2025 bei NewScientist Jobs gefunden Gilead Sciences, Inc.

Associate Director, Global Regulatory Affairs, Oncology

• Cambridge, United Kingdom, Cambridgeshire Führungs-/ Leitungspositionen At Gilead, we re creating a healthier world for all people. For more than 35 years, we ve tackled diseases such as HIV, viral hepatitis,[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we re looking for the next wave of passionate and ambitious [...] filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product (s) . Examples include meeting requests, briefing packages, original Investigational New Drug (IND) , IND amendment, and routine submissions (e. g. , Development Safety Update Reports/ DSURs, Investigator Brochure/ IB updates, etc. ) . Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents [...] (i. e. without regard to protected characteristics or prohibited grounds, which may include an individual s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws) . Gilead also prohibits discrimination based on any [...]
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