Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Position Summary
As Medical Writing Asset Lead Director, you will apply experience, scientific and operational expertise, and leadership in a matrix organization to provide the medical writing strategy for one or more assets. You will design and deliver high-quality fit for purpose clinical documents for global regulatory submissions, plan for efficient and accelerated ways of working, and contribute to key organizational process improvements.
You will balance scientific rigor with practical execution, champion efficient and accelerated ways of working, and proactively identify opportunities to simplify document lifecycle, reduce risk and strengthen submission quality across the asset lifecycle. We value collaborative leaders who apply sound judgement, practical problem solving and inclusive coaching to enable high-performing teams and successful outcomes.
This role offers meaningful impact, visible growth opportunities, and a chance to unite science, technology and talent to get ahead of disease together.
Key Responsibilities:
1. Providing key contributions to clinical document strategy for one or more assets throughout the life cycle of drug development. Documents in scope include, but are not limited to, clinical study protocols, clinical sections of the IMPD/IND, Investigator’s Brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overviews, and responses to regulatory authority questions.
2. Leading matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed.
3. Planning and successfully delivering large submissions independently, effectively recommending innovative methods and solutions for achieving accelerated timelines. Assessing and adapting to interdependences of various contributing functions and managing problems affecting timelines as necessary. Ensuring a global approach for submissions as appropriate, collaborating with Global Regulatory Affairs to ensure business needs and regulatory requirements are met. Providing guidance and facilitation to submission teams in development of detailed submission plans.
4. Acting as lead author on submissions. Effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions.
5. Proposing resourcing solutions for major projects including the number of FTEs required and best use of internal and external resources.
6. Actively contributing to development of training materials for therapeutic area and providing mentoring and/or training on regulatory requirements, medical writing processes, and submission planning to individuals or teams.
7. Driving, promoting and implementing key organizational process improvement initiatives. Proactively generating ideas for simplification and improvement taking advantage of opportunities that arise and challenging the status quo.
8. Prioritizing and meeting multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix.
9. Promoting leadership behaviors that support GSK values.
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
10. Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline
11. Extensive experience in clinical regulatory writing in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.
12. Extensive experience in project management, planning, communication, and demonstrated matrix leadership to deliver results
13. Excellent understanding of clinical operations / medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval.
14. Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
15. Experience in delivering accelerated submissions for EU, US, China, Japan and Rest of World.
16. Experience in clinical pharmacology applied to clinical development and pharmacokinetic/pharmacodynamic (PK/PD) interpretation.
17. Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.
#LI-GSK*
The annual base salary in Poland for new hires in this position ranges from PLN 0 to PLN 0 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.
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.