Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
- Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards.
- Translate complex clinical and statistical data into clear, accurate, and well-structured scientific narratives for diverse audiences.
- Act as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
- Drive process improvement initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.
Why You: Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor’s degree in life sciences, health sciences, or a scientific field.
- 5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
- 3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
- 3+ years of experience independently authoring clinical protocols, clinical study reports, and regulatory submission documents.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
- Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field.
- Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers.
- Familiarity with statistical concepts and ability to interpret clinical data.
- Strong problem-solving skills and ability to adapt to changing priorities.
- Experience working in multicultural or remote team settings.
- Proven ability to independently write and manage complex regulatory documents.
- Strong understanding of International Council for Harmonization (ICH) guidelines and Good Clinical Practice (GCP).
- Excellent written and verbal communication skills, with attention to detail.
- Experience managing multiple projects and meeting deadlines in a fast-paced environment
Please visit [_GSK US Benefits Summary_](http://us.gsk.com/media/7992/ustrataglance-jobpostings.pdf) to learn more about the comprehensive benefits program GSK offers US employees.
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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - _usrecruitment.adjustments@gsk.com_ 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.
Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at [_https://openpaymentsdata.cms.gov/_](https://openpaymentsdata.cms.gov/)
