Scientific and Medical Writing – Oncology

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 :

Job Related Experience :

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. 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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