Director Medical Writing Submission Facilitator

Il y a 4 mois


Wavre, Belgique GSK Temps plein

**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 genetics and advanced technologies, such as functional genomics and AI/ML.

**Job Purpose**:
**Key Responsibilities**:

- Partners with the MW LT and MW Submission leads in developing, driving, implementing and embedding accelerations levers in a multi-cultural, cross-functional, and cross
- Therapy Area setting including senior stakeholders.
- Be a change champion and strong advocate for embedding and utilizing Acceleration Levers and relevant Hyper Acceleration technology in the hyper-acceleration ambition submission teams in a multi-cultural, cross-functional, and cross Therapy Area setting including senior stakeholders.
- Leads, drives and promotes MW acceleration strategy and represents MW in hyper-acceleration ambition submission forums such as the Acceleration Squad Meetings.
- Proactively generates ideas for simplification and improvement in the area of hyper-acceleration ambition submissions.
- Builds interactive relationships with Functional leads and senior stakeholders in the context of acceleration.
- Removes blockers to hyper-acceleration ambition submission acceleration and escalates issues.
- Ensures relevant stakeholder management in close collaboration with the MW Head, MW Head of H&E and Medical Writing TA Heads.
- Highly pragmatic with strong negotiation skills.
- Facilitates execution of agreed timelines for the clinical submission document within the remit of Medical Writing in close collaboration with the Medical Writing Submission Lead and Submission Medical Writer Lead Authors.
- Promotes agility in ways of working within submission teams.
- Ensures submission teams are trained in the MW owned acceleration levers and Hyper Acceleration technology.
- Ability to oversee and support multiple hyper-acceleration ambition submission teams in parallel.

**Basic Qualifications**:

- PhD degree in Life Science/ Health Science or equivalent.
- Extensive years of experience in clinical submissions dossier work as an SME - corresponding to Director/Program Lead - in a global Pharma R&D or CRO setting with a profound understanding of the clinical development process and phases of development.
- Demonstrated influential skills in a fast-paced, high-pressure multi-cultural environment.
- Track-record of delivering business outcomes and value and simplification with a passion for science and advancing medicines to patients
- Experience in multicultural settings, diverse environments with respect to dynamics of human interaction.
- Excellent strategic, planning and organizational skills.
- Excellent interpersonal skills
- Strong problem-solving and negotiation skills
- Highly structured and diligent.
- Relentless for delivering business outcomes and value and simplification with a passion for science and advancing medicines to patients
- Excellent communication skills in verbal and written English.

**Preferred Qualifications**:

- Being able to navigate a complex matrix organisation with an ability to partner with, and influence, senior stakeholders across the company.

LI-GSK*

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Important notice to Employment businesses/ Agencies



  • Wavre, Belgique GSK Temps plein

    **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...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga **Posted Date**: Sep 3 2024 As SERM Associate Medical Director you will provide medical expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. You will ensure scientifically sound review and interpretation of...


  • Wavre, Belgique Abbott Laboratories Temps plein

    **Medical Manager, Abbott Diabetes Care (BENELUX)** **Location**: Headquarters in Belgium **Primary Function**: - Interact with key stakeholders in the medical community, providing training and scientific advice on Abbott Diabetes Care monitoring solutions. - Contribute to the design of local clinical trials, ensuring meaningful differentiation of Abbott...

  • Principal Medical Writer

    il y a 2 semaines


    Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre **Posted Date**: Nov 29 2024 **Your responsibilities**: - Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. - Work in a...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, Philadelphia Walnut Street, UK - London - New Oxford Street, USA - Massachusetts - Waltham, USA - North Carolina - Durham **Posted Date**: Oct 4 2024 The** **Senior Director, Global Medical Education & Customer Experience Delivery** will work above Therapeutic Areas and...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre **Posted Date**: Nov 15 2024 **Job Purpose**: Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: Belgium-Wavre, GSK HQ, USA - Pennsylvania - Upper Providence **Posted Date**: Aug 22 2024 Are you looking for an opportunity to manage and implement safety processes aligned to medical governance and policies while working across diverse cultures and environments? If so, this is the role for you. This role will provide YOU the opportunity to...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, Philadelphia Walnut Street, UK - London - New Oxford Street, USA - North Carolina - Durham **Posted Date**: Oct 4 2024 The purpose of the **Senior Director, Global Content Creation Oncology r**ole is to develop, maintain and oversee the development and delivery of the Global...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, UK - London - New Oxford Street, USA - Maryland - Rockville **Posted Date**: Oct 8 2024 Established as a focused global function**, Data Generation & Scientific Communications**, is uniquely placed to help accelerate the successful integration of our medicines and vaccines...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga **Posted Date**: Sep 3 2024 As SERM Associate Scientific Director you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. You will ensure scientifically sound review and interpretation...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: GSK HQ, Belgium-Wavre, Canada - Ontario - Mississauga **Posted Date**: Oct 11 2024 As SERM Associate Scientific Director you will provide scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting. You will ensure scientifically sound review and interpretation...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London - New Oxford Street, USA - District of Columbia - Washington Dc, USA - Massachusetts - Waltham **Posted Date**: Nov 14 2024 GSK is a global healthcare company committed to improving the quality of human life by enabling people to do more, feel better, and live longer. We...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Herpes zoster**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Pneumococcal MAPS**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - RSV**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre, USA - Pennsylvania - Upper Providence **Posted Date**: Sep 23 2024 **Senior Director, Global Real-World Evidence & Health Outcomes Research Lead - Belimumab**: For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market...


  • Wavre, Belgique Abbott Laboratories Temps plein

    For our Diabetes Care division, we are recruiting a Senior Regulatory Specialist for Benelux. The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to an agreed schedule. Role and Responsibilities: - Formulate, develop and manage a program...


  • Wavre, Belgique GSK Temps plein

    **Site Name**: USA - Pennsylvania - Upper Providence, Belgium-Wavre, UK - London - New Oxford Street **Posted Date**: Oct 10 2024 For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market position. Specifically, evidence must be maintained throughout the product lifecycle as...

  • Serm Scientific Director

    Il y a 3 mois


    Wavre, Belgique GSK Temps plein

    **Site Name**: UK - London - New Oxford Street, Belgium-Wavre **Posted Date**: Sep 23 2024 **Job Description**: **Job Purpose**: Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of...

  • Head of Regulatory Affairs

    il y a 3 semaines


    Wavre, Belgique PaHRtners Temps plein

    - Type of role Regulatory & Medical Affairs Share Our client is a biotechnology company based in Liège. This human-sized structure provides innovative solutions to medical needs concerning infections, with the ambition of progressing towards the next clinical steps. To support growth and join the team, we are actively looking for a: Head of Regulatory...