Director Medical Writing Submission Facilitator

GSK; Stevenage; On-site; GBP 120,000 - 160,000; Full time

Job summary

GSK is seeking a Director Medical Writing Submission Facilitator to drive the submission acceleration program across diverse therapy areas. You will lead strategic initiatives, collaborate with senior stakeholders, and promote acceleration levers and technology to deliver timely, high-quality clinical submissions.

You will be responsible for enabling agile processes, aligning with MW Heads and TA leaders, and removing blockers to ensure on-time delivery of critical documents in a fast-paced

Qualifications

• PhD degree in Life Science or Health Science, or equivalent.
• Extensive years of experience in clinical submissions dossiers as a subject matter expert – Director/Program Lead – in global pharma R&D or CRO settings.
• Proven track record delivering business outcomes and value with a passion for science and advancing medicines.

Responsibilities

• Partners with MW Leadership Team and MW Submission leads to develop and embed acceleration levers across multiple therapy areas.
• Champions the use of acceleration technology and MW related tools in cross-functional teams.
• Leads MW acceleration strategy and represents MW in acceleration submission forums.

Skills

Clinical Development

Clinical Trial Designs

Communication

Decision Making

Emotional Intelligence

Influencing Without Authority

Learning Agility

Literature Reviews

Medical Writing

Pharmaceutical Industry

Presentation Techniques

Regulatory Submissions

Scientific Writing

Strategic Thinking

Education

PhD degree in Life Science/ Health Science or equivalent

Job description

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

The Director Medical Writing Submission Facilitator would be responsible to facilitate the GSK submission acceleration ambition by being a strong advocate and change champion for ensuring the medical writing driven acceleration levers and acceleration technology are embedded and utilized optimally ensuring Medical Writing (MW) acceleration ambition deliverables are delivered to time and quality by applying expert leadership, scientific and operational expertise and strong influential skills.

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 technology in the 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 acceleration submission forums.
• Proactively generates ideas for simplification and improvement in the area of accelerating submissions.
• Builds interactive relationships with Functional leads and senior stakeholders in the context of acceleration.
• Removes blockers to accelerating ambition submissions 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 technology.
• Ability to oversee and support multiple 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.

Skills

• Clinical Development
• Clinical Trial Designs
• Communication
• Customer Service
• Decision Making
• Emotional Intelligence
• Influencing Without Authority
• Learning Agility
• Literature ReviewsMedical Writing
• Pharmaceutical Industry
• Presentation Techniques
• Regulatory Submissions
• Scientific Writing
• Strategic Thinking

Why GSK?

Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.

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We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 they 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. Find out more on our career site.