Are you energized by the opportunity to take a leadership role in writing clinical study-related documents and supporting the writing of selected regulatory documents from scientific and clinical project data to meet the needs of licensing authorities? If so, this Medical Writing & Clinical Submission Planning Associate Director opportunity could be an ideal opportunity to explore.
As a Medical Writing & Clinical Submission Planning Associate Director, you will 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.
In the US, this position can be based at the GSK Collegeville, PA, in RTP, NC, or can be remote-based within the US East coast or US Central time zones.
In Canada, this position can be based in Toronto, or can be remote-based in a location within the Eastern, Atlantic, Newfoundland, or Central time zones.
In the UK, this position can be based at the London - Brentford (GSK House) or Hertfordshire - Stevenage locations or can be remote-based within the UK.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you?Basic Qualifications:
- Write key clinical documents in support of clinical project(s).
- Direct the work of medical writing teams in medical writing projects in support of the clinical project strategy.
- Contribute to the planning, authoring, review, and approval of clinical documents for medical writing project to achieve a successful outcome within the required timelines.
- Assess trends and patterns in text and statistical data, and effectively organizes 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.
- Provide input to submission teams in development of submission plans, timelines, document content and dependencies. Advise on or recommend methods for achieving accelerated timelines as necessary.
- 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.
- Manage development of contracts/invoices and provide oversight for outsourced medical writing activities.
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in life sciences
- Experience 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.
If you have the following characteristics, it would be a plus:
- Master's or doctorate degree in life sciences
- Experience contributing in planning and production of clinical dossier documents for regulatory submissions worldwide.
- Experience with the planning, authoring, review, and approval of clinical documents for medical writing project to achieve a successful outcome within the required timelines.
- Experience managing projects of increasing scope and complexity.
- Experience assessing trends and patterns in text and statistical data and organizing content and messages in clinical reports and summary documents
- Experience reviewing reporting and analysis plans and providing critical input on the content and display of tables.
- 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 technical, statistical, and computer skills, and the ability to interpret complex clinical data.
- Familiarity with approaches to expedite document preparation such as review tools and automation.
- Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas).
- Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. *This is a job description to aide in the job posting, but does not include all job evaluation details.
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