Scientific and Medical Writing – Oncology

Title: Scientific and Medical Writing – Oncology

Company: GlaxoSmithKline
Location: Mississauga, Ontario
Job Type: FullTime

Description:

The Associate Director Medical Writer is an individual expert responsible for managing and preparing clinical/regulatory documents to support clinical project strategies. This role requires the ability to independently execute complex writing assignments and have a thorough understanding of clinical trial designs and research data interpretation. The individual will provide major input into marketing application submission planning and execution, as well as champion change in implementing best practices and continuous improvement.

Key Responsibilities:

Contribute to planning, authoring, reviewing, and approving clinical/regulatory documents

Provide major input to submission teams

Develop training materials and provide mentoring on clinical documentation

Contribute to process improvement initiatives

Effectively contribute to process improvement activities

Education Requirements:

PhD or relevant working experience within the life sciences space

Job Related Experience:

Proven track record in writing clinical/regulatory documents

Experience in planning and producing clinical dossier documents for regulatory submissions

Understanding of various contributing functions and scientific methodology

Ability to interpret clinical data and assess trends

Excellent English language skills

Why GSK? GSK is a global biopharma company focused on uniting science, technology, and talent to impact the health of 2.5 billion people by the end of the decade. GSK offers a culture of ambition, accountability, and doing the right thing, providing an environment where people can thrive. GSK is an Equal Opportunity Employer committed to accommodating persons with disabilities and ensuring equal consideration for all qualified applicants.

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Title: Scientific and Medical Writing – Oncology
Company: GlaxoSmithKline
Location: Mississauga, Ontario
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 improvementKey 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 crossfunctional 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.

Job Related Experience:

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, fitforpurpose 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.
 Highlevel 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)

LIHYBRIDWhy 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 email and instead apply through the online application process of this posting.Important notice to Employment businesses/ AgenciesGSK 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.

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