Associate Director, Medical Writing & Clinical Submission Planning
City : 7333 Mississauga Road North
Category : Other
Industry : Healthcare
Employer : GSK
Posted Date: Jan 27 2022
Are you energized by the opportunity to lead a team to write clinical study related documents and support 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 Manager opportunity could be an ideal opportunity to explore.
As a Medical Writing & Clinical Submission Planning Manager 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
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 major input to submission teams in development of submission plans, timelines, document content and dependencies. Advises on or recommends 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.
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.
If you have the following characteristics, it would be a plus:
Master’s degree in life sciences
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.
We are open to a remote work schedule if you do not reside near a GSK site.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams
Continuously looking for opportunities to learn, build skills and share learning both internally and externally
Developing people and building a talent pipeline
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally
Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
Important notice to Employment businesses/ Agencies
GSK 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.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.