Job Description

Job Purpose:

The Associate Director Medical Writer is an individual expert who can manage and prepare clinical/regulatory documents in support of the clinical project strategy. As well as being able to independently execute complex writing assignments, this role has a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. He/she would be expected to provide major input into marketing application submission planning and execution in a variety of other clinical documents. This role has extensive clinical document expertise and will champion change in the implementation of best practices and continuous improvement.

Key Responsibilities:

• Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines.
• Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level.
• Provide major input to submission teams in development of submission plans, timelines, document content and dependencies.
• Advises on or recommends methods for achieving accelerated timelines, including review tools and automation.
• Actively contribute to development of training materials for clinical document preparation; provides mentoring and/or training on clinical documentation and submission planning to individuals or teams.
• Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents.
• Effectively contribute to process improvement activities.

Education Requirements:

• PhD or relevant working experience within the life sciences space.

Basic Requirements:

• Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements.
• Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide.
• Demonstrated effectiveness in management of projects of increasing scope and complexity.
• Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome).
• Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions.
• High-level computer skills and general computer literacy.
• Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
• Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents.
• Review reporting and analysis plans and provides critical input on the content and display of tables.
• Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
• Effectiveness in both oral and written communications.
• Possesses a good understanding of drug development
• Possesses working knowledge of International Committee for Harmonisation (ICH)/Good Clinical Practice (GCP).
• Excellent English language skills (verbal and written)

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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GlaxoSmithKline