Medical Writing Asset Lead

1 mese fa


Siena SI, Italia GlaxoSmithKline 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 therapy area specific medical writing projects or programs as appropriate in support of the clinical strategy to meet business and regulatory needs, and potentially leading projects across products.

Your responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • You provide key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents like protocols, clinical study reports, clinical study register summaries, common technical document summaries and Clinical Overview among other documents.
  • You lead matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed.
  • You ensure global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary. Ideally works in collaboration with GRA to ensure business needs are met for new chemical entities and post approval documentation.
  • You 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.
  • You demonstrate an understanding of the interdependences of various contributing functions and manage problems affecting timelines as necessary.
  • You demonstrate an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.
  • You propose resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.
  • You effectively organize content and argument in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.
  • You 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.
  • You have the ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.

Why you?

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

  • Master’s degree in any scientific related field
  • Hands on experience with medical writing and clinical regulatory document is a must
  • Demonstrated experience managing multiple strategic partnerships
  • Experience or exposure to submission documents
  • Great sense of leadership in order to guide people
  • Outstanding communication skills to interact with different stakeholders
  • Fluency in English is a must, any other language is an asset
  • Ability to evolve in a matrix environment

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

  • PhD, PharmD, MPH, MS or other post-graduate degree
  • Possesses highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
  • Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
  • Experience analysing complex scientific & operational information and implementing effective solutions.
#J-18808-Ljbffr

  • Siena, Italia Glaxosmithkline 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 therapy area specific medical...


  • Siena, Italia Glaxosmithkline 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 therapy area specific medical writing...


  • 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...


  • 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...


  • Siena, Toscana, Italia GlaxoSmithKline A tempo pieno

    Job Title:Clinical Writing LeaderLocation: Belgium-Wavre, Italy - SienaSalary: Estimated €80,000 - €110,000 per year (dependent on qualifications and experience)Job Description:We are seeking a highly skilled Clinical Writing Leader to join our team at GlaxoSmithKline. As a key member of our medical writing department, you will be responsible for leading...


  • 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...


  • Siena, Italia Gsk A tempo pieno

    **Site Name**: Wavre, Italy - Siena, Mississauga**Posted Date**: Aug 30 2024GSK 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 genetics...

  • Lead Statistician

    1 mese fa


    Siena (SI), Italia GSK A tempo pieno

    Site Name: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas Posted Date: Nov 12 2024 Job Purpose Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the manufacture of critical vaccines and...


  • 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...

  • Lead Statistician

    1 mese fa


    Siena, Italia GSK A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas **Posted Date**: Nov 12 2024 Job Purpose We have an exciting opportunity for a Lead Statistician to join our global Digital and Data Science group, dedicated to supporting the launch of medicinal products to market and their subsequent product lifecycle within manufacturing....

  • Lead Statistician

    1 settimana fa


    Siena, Italia Gsk A tempo pieno

    **Site Name**: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas**Posted Date**: Nov 12 2024Job PurposeWe have an exciting opportunity for a Lead Statistician to join our global Digital and Data Science group, dedicated to supporting the launch of medicinal products to market and their subsequent product lifecycle within manufacturing. Our...

  • Lead Statistician

    1 mese fa


    Siena, Italia Gsk A tempo pieno

    Site Name: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas Posted Date: Nov 12 2024 Job Purpose Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the manufacture of critical vaccines and medicines?...

  • Lead Statistician

    1 mese fa


    Siena, Italia GSK A tempo pieno

    Site Name: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas Posted Date: Nov 12 2024 Job Purpose Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the manufacture of critical vaccines and medicines?We...

  • Lead Statistician

    4 settimane fa


    Siena, Italia Gsk A tempo pieno

    Site Name: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas Posted Date: Nov 12 2024 Job Purpose Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the manufacture of critical vaccines and medicines?We...


  • Siena (SI), 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...


  • 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...


  • 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...


  • 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 preparation).-...


  • 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 ...


  • 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...