Amgen Jobshttp://www.amgen.jobs2012-05-27 01:17:17.757688GBRUxbridgeAuto req 15165BR Job Posting Title International Dev Medical Dir Career Category Clinical Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description Overview: This is a newly formed role in the International Bone, Neuroscience & Inflammation TA. AMG 785 is a key program for Amgen and reached EoP2 in summer 2011 for the PMO program and is advancing into phase 3 with two phase 3 PMO protocols, currently planned to start enrollment in 2012. Ongoing phase 2 activities for this molecule includes fracture healing programs in hip and tibia fracture. Proof of concept does not yet exist in these indications. It is expected that the IML for AMG 785 partners with the Prolia IML as appropriate, since strategic alignment is required between these two molecules (partnered with UCB and GSK respectively). Key responsibilities: • Implementation and completion of AST’s (Amgen sponsored studies) • Leads development of study protocols for International AST’s; supports and executes international study protocol preparation, filing, review and approval in line with Amgen processes and policies • Ensures that International input is included as appropriate in GSP/GDP and global study protocols and SCD’s • Supports Affiliates in protocol development of Local AST’s and approves Local AST’s prior to IPRC submission (in conjunction with GDO) • Identify/resolve issues related to study design that arise during study execution • Provides interpretation of clinical study data and preparation/authoring of technical sections of clinical study reports, ensure consistency of CSRs for a clinical program • Participates in the development of Global strategies and tactics in close collaboration with the GDL and the International TA Head • Visits selected KOLs and study groups for strategic discussions and protocol development • Reviews International and Local ISS proposals • Partners with the International Brand Directors in the development and execution of the International product(s) lifecycle management plan • Oversees in-sourced/outsourced International medical programs and logistics • Supports regulatory and ethics approvals for Global development studies • Organizes and/or conducts International Advisory Board Meetings/Expert Panels and participates in Investigator Meetings, as appropriate • Member of respective IBT • Provides medical expertise for pipeline products • Provides medical expertise for Health Economy and reimbursement requests • Chairs the International Medical Team (IMT) Basic Qualifications • Medical degree with deep scientific expertise in Preferred Qualifications • Substantial clinical development experience, preferably from a pharmaceutical or possibly well established biotechnology company • Experience with clinical study management and conduct • Broad and formal leadership experience • Commercial acumen, ideally launch experience • Knowledge of pharmaceutical product development, product lifecycle and commercialisation process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs • Therapeutic area knowledge • Network of customer contacts in therapeutic area • Finance and budgeting experience2012-04-24 20:49:23United KingdomAmgenNone15165BRNoneUxbridge, GBR28152716http://www.amgen.jobs/xml/28152716/jobGBRUxbridgeAuto req 14152BR Job Posting Title Corporate Communications Senior Mgr Career Category Marketing Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description Overview: The jobholder will be accountable for the development and implementation of a UK-wide internal communications plan to include staff engagement strategies and activities; International R&D messaging; audience insights; use of appropriate channels; communication programs into global R&D and the International Organisation. The jobholder will lead and manage assigned International projects and provide internal and change communications counsel to key assigned internal stakeholders Key Responsibilities: - Apply a solid understanding of the business and assigned client goals and priorities, as well as the issues clients face locally, to provide effective communications guidance and recommendations. - Develop and support implementation of UK-wide staff engagement and communications plan Serve as a member of the ALMT, flagging new developments, opportunities, threats, making recommendations and sharing best practice. - Partner closely with R&D executives, HR and affiliate leadership, as well as affiliate communicators, to ensure internal/ external and business alignment - Facilitate effective relationships between different functions in UK on all relevant communications activities. - Serve as single point of contact for Global Communications and client groups requiring UK or assigned functional and regional support. - Provide insights/ updates to the Global R&D communications team to ensure that IRD is better understood and integrated into global functional communications. - Ensure IRD is adequately represented and addressed in International (regional) communications. - Develop and manage local internal communications infrastructure and tools. - Build and sustain relationships with key internal stakeholders. - Develop and support implementation of internal communications plans consistent with Amgen’s global, functional and International communications strategies, and aligned with local/ functional/ regional objectives. Basic Qualifications - Bachelor's Degree in English, Journalism, Communications or the equivalent combination of education and experience Preferred Qualifications Experience and Skill: - Relevant experience and proven track record in international corporate communications, ideally gained in pharmaceutical or healthcare; agency experience a plus - Broad communications experience, with depth in internal communications and change management - Demonstrated business acumen, and proven track record of advising executives and leadership - Ability to select, engage and manage a public relations firm - Outstanding oral, written and presentation skills - Strategic approach to communications and program development - Excellent written and verbal command of English (mother tongue preferred); proficiency in other languages an advantage Knowledge: - Knowledge of pharmaceutical/ biotech industry - Knowledge of digital and interactive media and how to apply it to internal communications - Cultural understanding - Knowledge of change management2012-03-02 18:38:02United KingdomAmgenNone14152BRNoneUxbridge, GBR26890895http://www.amgen.jobs/xml/26890895/jobGBRUxbridgeAuto req 13137BR Job Posting Title Regulatory Affairs Mgr Career Category Regulatory Employee Subgroup Salaried FT Country (State/Region) United Kingdom Location (City) Uxbridge Amgen Job Description 40001053, Amgen Job Description To Be Added When Table Structure is Built Basic Qualifications 40001053, To Be Added When Table Structure is Built- Basic Qualifications Preferred Qualifications 40001053, To Be Added When Table Structure is Built, - Preferred Qualifications2011-12-21 22:00:18United KingdomAmgenNone13137BRNoneUxbridge, GBR25502621http://www.amgen.jobs/xml/25502621/job