Director Medical Writing Submission Facilitator

• 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.

#LI-GSK*

Skills

Clinical Development, Clinical Trial Designs, Communication, Customer Service, Decision Making, Emotional Intelligence, Influencing Without Authority, Learning Agility, Literature Reviews, Medical 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.

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