Lavori attuali relativi a Medical Writing Asset Lead - Siena, Toscana - GlaxoSmithKline

  • Lead, Bioassay and Sample Management Specialist

    4 settimane fa

    Siena, Toscana, Italia CSL Seqirus A tempo pieno

    Job Title: Lead, Bioassay and Sample ManagementCSL Seqirus is seeking a highly skilled and experienced professional to lead our Bioassay and Sample Management team. As a key member of our Clinical Development team, you will be responsible for ensuring the on-time delivery of sample data and end-to-end central laboratory management across our global Clinical...

  • Lead, Bioassay and Sample Management Specialist

    3 settimane fa

    Siena, Toscana, Italia CSL Seqirus A tempo pieno

    Job Title: Lead, Bioassay and Sample ManagementCSL Seqirus is seeking a highly skilled and experienced professional to lead our Bioassay and Sample Management team. As a key member of our Clinical Development team, you will be responsible for ensuring the timely delivery of sample data and end-to-end central laboratory management across our global portfolio...

  • Global Clinical Safety and Pharmacovigilance Director, Serm Head

    7 giorni fa

    Siena, Toscana, Italia Glaxosmithkline A tempo pieno

    About the Role:The Global Clinical Safety and Pharmacovigilance Director, Serm Head will lead the Safety Evaluation and Risk Management (SERM) medical and scientific staff and define the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies.Key Responsibilities:Translate strategic plans...

  • Lead, Bioassay and Sample Management Specialist

    3 settimane fa

    Siena, Toscana, Italia CSL Seqirus A tempo pieno

    Job SummaryThe Bioassay and Sample Management Lead is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.Key ResponsibilitiesResponsible for the planning, oversight of in-study end to end sample management including central testing...

  • Scientific Leader

    2 settimane fa

    Siena, Toscana, Italia 12371 GSK Vaccines S.r.l. A tempo pieno

    About the RoleWe are seeking a highly skilled Scientific Leader to join our team at 12371 GSK Vaccines S.r.l. As a key member of our organization, you will be responsible for leading our scientific efforts in disease prevention and treatment.Key ResponsibilitiesDevelop and implement scientific strategies to prevent and treat diseasesLead cross-functional...

  • Senior IT/OT System Architect

    2 mesi fa

    Siena, Toscana, Italia MAASI Enterprises Ltd A tempo pieno

    About the RoleMAASI Enterprises Ltd, a leading consulting firm in the Life Science industry, is seeking a highly skilled Senior IT/OT System Architect to join our team.The ideal candidate will have a proven track record of experience in IT/OT systems integration and a passion for delivering innovative solutions in a dynamic and international environment.As a...

  • Medical Writing Asset Lead

    2 mesi fa

    Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Belgium-Wavre, Italy - SienaPosted Date: Sep 6 2024Job purpose: Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.As a Medical Writing Asset Lead, you will lead therapy area specific medical writing...

  • Medical Writing Asset Lead

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena **Posted Date**: Sep 6 2024 **_ Job purpose:_** ***: **Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so, this Medical Writing Asset Lead role could be an ideal opportunity to consider.**: ***: **As a Medical Writing Asset Lead, you will lead...

  • Director Medical Writing Submission Facilitator

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Wavre, Italy - Siena, Mississauga **Posted Date**: Aug 30 2024 GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...

  • Medical Scientific Liaison

    5 mesi fa

    Siena, Italia Grifols Italia SpA A tempo pieno

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...

  • Global Regulatory Affairs Manager, Vaccines

    1 settimana fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Siena, Switzerland - Zug, UK - London - New Oxford Street, USA - Maryland - Rockville, Warsaw Rzymowskiego 53 **Posted Date**: Oct 31 2024 **Global Regulatory Affairs Manager, Vaccines Therapeutic Group**: Job purpose: As a **Global Regulatory Affairs (GRA) Manager**, you will join the GRA Vaccines Therapeutic Group in...

  • Junior Pharmacovigilance Associate

    6 mesi fa

    Siena, Italia Philogen A tempo pieno

    **Location: Siena - Italy** *** **Department: Clinical** *** **Junior Pharmacovigilance Associate** Philogen S.p.A. would like to hire a Junior Pharmacovigilance Associate. The role will report directly to the Responsible of Pharmacovigilance. - Collaboration in the assessment, triage and management of SAEs and SUSAR submission (e.g. CIOMS-I form...

  • Lead, Bioassay And Sample Management

    2 settimane fa

    Siena, Italia Csl Seqirus A tempo pieno

    The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL's laboratory management strategy, processes and standards, support the selection and oversees...

  • Lead, Bioassay and Sample Management

    3 settimane fa

    Siena, Italia CSL Seqirus A tempo pieno

    The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...

  • Lead, Bioassay and Sample Management

    4 settimane fa

    siena, Italia CSL Seqirus A tempo pieno

    The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials. As the L-BSM you will establish CSL’s laboratory management strategy, processes and standards, support the selection and...

  • Lead, Bioassay And Sample Management

    1 settimana fa

    Siena, Italia Csl Seqirus A tempo pieno

    The Lead; Bioassay and Sample Management (L-BSM) is accountable for ensuring the on-time delivery of sample data and end-to-end central laboratory management across the global Clinical Development portfolio of CSL Clinical Trials.As the L-BSM you will establish CSL's laboratory management strategy, processes and standards, support the selection and oversees...

  • Executive Director, SERM Head

    6 mesi fa

    Siena, Italia 12371 GSK Vaccines S.r.l. A tempo pieno

    Position summary The Executive Director, Safety Evaluation & Risk Management (SERM) Head is accountable to lead SERM (Safety Evaluation & Risk Management) medical and scientific staff and define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies. Competencies ...

  • Communications and Events Internship, Castello di

    6 mesi fa

    Siena, Italia Belmond A tempo pieno

    As a Communications and Events Intern at Castello di Casole, A Belmond Hotel, Tuscany, you are part of a team that coordinates extraordinary experiences. In this role, you will assist in coordinating events and making engaging Communications campaigns that show off the special charm and luxury experiences of our destination. **Primary Responsibilities...

  • Communications and Events Internship, Castello di

    6 mesi fa

    Siena, Italia Belmond Management A tempo pieno

    As a Communications and Events Intern at Castello di Casole, A Belmond Hotel, Tuscany, you are part of a team that coordinates extraordinary experiences. In this role, you will assist in coordinating events and making engaging Communications campaigns that show off the special charm and luxury experiences of our destination. **Primary Responsibilities...

  • Director, Pipeline Project Management

    1 mese fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, Italy - Siena **Posted Date**: Sep 25 2024 **Director, Pipeline Project Management - Vaccines**: Pipeline Project Management drives decisions and enables teams to choose the best path and deliver medicines to patients faster than ever. In GSK, the Pipeline Project Manager (PPM) will act as the...

  • Scientific Director

    22 ore fa

    Siena, Italia Glaxosmithkline A tempo pieno

    Site Name: Italy - Siena, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Nov 5 2024 The Scientific Director in the Infectious Disease Research team (Siena, or Upper Providence, Stevenage) is highly motivated and talented with expertise in mAb drug discovery for infectious diseases and project leadership.The Scientific...

  • Scientific Director

    2 giorni fa

    Siena, Italia GlaxoSmithKline A tempo pieno

    Site Name: Italy - Siena, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Nov 5 2024The Scientific Director in the Infectious Disease Research team (Siena, or Upper Providence, Stevenage) is highly motivated and talented with expertise in mAb drug discovery for infectious diseases and project leadership. The Scientific...

  • Isf ( Sales Representative ) Toscana

    4 settimane fa

    Siena, Italia Boehringer Ingelheim Gmbh A tempo pieno

    The PositionVisit health practitioners within the area of competence, in order to promote drugs and to communicate their pharmaceutical and therapeutic characteristics, adopting adequate communication techniques and acting within the company' strategy in compliance with company policies and current regulations.Responsibilities:Ensure the activity of medical...

  • Statistics Director

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Amsterdam, Collegeville TSA, Rockville Biopharm, Siena, Stevenage, Waltham, Wavre **Posted Date**: Aug 29 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational...

  • Statistics Leader

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: UK - London - New Oxford Street, Amsterdam, Collegeville TSA, Rockville Biopharm, Siena, Stevenage, Waltham, Wavre **Posted Date**: Aug 29 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational...

  • Associate Scientist

    2 mesi fa

    Siena, Italia GSK A tempo pieno

    **Site Name**: Italy - Siena **Posted Date**: Sep 18 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work...

Medical Writing Asset Lead

2 mesi fa

Siena, Toscana, Italia GlaxoSmithKline A tempo pieno
Job Summary

We are seeking a highly skilled Medical Writing Asset Lead to join our team at GlaxoSmithKline. As a Medical Writing Asset Lead, you will play a critical role in leading therapy area specific medical writing projects or programs in support of our clinical strategy to meet business and regulatory needs.

Key Responsibilities
  • Lead Clinical Strategy: Provide key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents.
  • Plan and Produce Clinical Documents: Lead matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed.
  • Ensure Global Approach: Ensure global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary.
  • Implement Large Submissions: Plan and successfully implement large submissions independently or in conjunction with the Medical Writing Director, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary.
  • Manage Timelines and Resources: Demonstrate an understanding of the interdependences of various contributing functions and manage problems affecting timelines as necessary.
  • Assess Complex Situations: Demonstrate an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.
  • Propose Resourcing Solutions: Propose resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.
  • Organize Content and Argument: Effectively organize content and argument in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.
  • Contribute to Training and Development: Actively contribute to development of training materials for therapeutic area scientists and provide mentoring and/or training on clinical documentation and submission planning to individuals or teams.
Requirements
  • Master's Degree: Master's degree in any scientific related field.
  • Medical Writing Experience: Hands on experience with medical writing and clinical regulatory document is a must.
  • Leadership and Communication Skills: Demonstrated experience managing multiple strategic partnerships, outstanding communication skills to interact with different stakeholders, and fluency in English is a must, any other language is an asset.
  • Ability to Evolve in a Matrix Environment: Ability to evolve in a matrix environment.