Associate Director, Scientific and Medical Writing
The Associate Director, Scientific and Medical Writing is responsible for leading HIV-focused regulatory writing activities (NDAs, MAAs, supplements, and related submissions) and for managing program-level writing efforts when appropriate. This role partners with clinical and regulatory teams to ensure deliverables align with the clinical strategy, meet business objectives, and satisfy regulatory timelines; it may also oversee projects that span multiple products.
Responsibilities
* Provides key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents including, but not limited to, protocols, clinical study reports,, common technical document summaries and Clinical Overview, briefing documents for regulatory authorities, responses to regulatory authority questions,, investigator brochures and annual reports.
* Leads matrix teams in planning and production of multiple clinical documents to support regulatory submissions worldwide, working with CROs and/or independent contractors as needed. Ensures global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary. Ideally works in collaboration with GRA to ensure business needs are met for new chemical entities and post approval documentation.
* Plans and successfully implements large submissions independently, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary. Recommends solutions for problems that affect timelines. Provides guidance and facilitation to submission teams in development of detailed submission plan.
* Ideally demonstrates an understanding of the interdependences of various contributing functions and manages problems affecting timelines as necessary. Ideally demonstrates an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.
* Proposes resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.
* Effectively organizes content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.
* Actively contributes to development of training materials for therapeutic area scientists and provides mentoring and/or training on clinical documentation and submission planning to individuals or teams. Ideally, proactively identifies medical writing training needs for staff and develops/implements training sessions.
* Has ability to prioritise effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.
Why You?
Basic Qualifications
* PhD or PharmD or MPH or MS
* Lead-author experience on regulatory submissions (documents including, but not limited to, clinical study reports, common technical document summaries and Clinical Overview, and briefing documents)
* Infectious disease experience
* Matrix leadership experience
Preferred Qualifications
* Scientific and operational experience to identify and analyze problems and information of considerable complexity and implements effective plans and solutions.
* Experience with quality decision making and creative problem resolution that impacts program/project direction.
* Strong oral and written communication skills
ViiV 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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee.
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