Associate Regulatory Writing

9 hours ago

Hyderabad, Telangana, India Amgen Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.Roles & Responsibilities:Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional teamEnsure consistent quality across documents, ensure submission readiness, and hand off for timely submission or postingCollaborate with team members to resolve problems and escalate issuesRecord and maintain written redaction strategy for the study and productManage timelines and coordinate work across teamExecute clinical trial disclosure business process and ensure deliverables and delivery timelines in compliance with regulations, Amgen policy and SOPs and guidance documents Tactical point of contact for assigned areas of responsibility, completes assigned action items, and maintains documentation of assigned responsibilitiesAssist/support trial disclosure audits and inspections Serve as Process Administer for CTRS, support active CTRS users, system access, inquiries, and issue resolutionGenerate /manage reports, trackers, portals and metric activitiesRequired Skills:Experience understanding and interpreting data/information and its practical applicationSelf-motivated with developed skills in multi-tasking, attention to detail, and follow-throughAbility to follow controlled processesExcellent spoken and written EnglishProject management skills, including ability to prioritize work in order to meet required deadlinesProblem solving abilityBasic Qualifications:Bachelor's degreeMinimum of 1 year experience working with regulatory documents in a biotech/ pharmaceutical environmentFamiliarity with clinical research and clinical regulatory documentsKnowledge of clinical trial disclosure regulations, guidelines, and best practicesPreferred Qualifications:> One year experience preparing regulatory documents for public disclosureFamiliarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), , EudraCT, EU CTIS, and other registriesFamiliarity with redaction/anonymization of clinical trial documentsEQUAL OPPORTUNITY STATEMENTAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation..

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