Medical Writing Asset Lead

2 settimane 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

  • Medical Writing Asset Lead

    1 settimana fa

    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...

  • 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

    3 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...

  • Clinical Writing Leader

    2 giorni fa

    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...

  • Director Medical Writing Submission Facilitator

    3 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...

  • Lead Statistician

    4 giorni 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...

  • 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...

  • 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 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

    5 giorni 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

    6 giorni 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...

  • Scientific Director

    2 settimane fa

    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...

  • Global Regulatory Affairs Manager, Vaccines

    3 settimane 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

    7 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...

  • Global Clinical Safety and Pharmacovigilance Director, Serm Head

    3 settimane 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...

  • Senior Clinical Safety Leader

    4 giorni fa

    Siena, Toscana, Italia Glaxosmithkline A tempo pieno

    Job SummaryWe are seeking a seasoned Senior Clinical Safety Leader to join our team at Glaxosmithkline. This is an exciting opportunity to lead our safety evaluation and risk management efforts, ensuring the highest level of patient safety globally.About the RoleThis critical role will be responsible for leading our senior medical and scientific staff in...

  • 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 oversees...

  • Lead, Bioassay and Sample Management

    1 mese 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 mese 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

    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 oversees...

  • Scientific Leader

    4 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...