Site Name: Belgium-Wavre, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage
Posted Date: Mar 21 2023
Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so this Medical Writing Asset Lead role could be an ideal opportunity to consider. As a Medical Writing Asset Lead, you will lead therapy area specific medical writing projects or programs as appropriate in support of the clinical strategy to meet business and regulatory needs, and potentially leading projects across products. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following\xe2\x80\xa6

• Provides key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents including, but not limited to, protocols, clinical study reports, clinical study register summaries, common technical document summaries and Clinical Overview, briefing documents for regulatory authorities, responses to regulatory authority questions, clinical sections of the IMPD for clinical trial applications, investigator brochures and annual reports.

• Leads matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed. Ensures global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary. Ideally works in collaboration with GRA to ensure business needs are met for new chemical entities and post approval documentation.

• Plans and successfully implements large submissions independently or in conjunction with the Medical Writing Director, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary. Recommends solutions for problems that affect timelines. Provides guidance and facilitation to submission teams in development of detailed submission plan.

• Ideally demonstrates an understanding of the interdependences of various contributing functions and manages problems affecting timelines as necessary. Ideally demonstrates an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.

• Proposes resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.

• Effectively organizes content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.

• Actively contributes to development of training materials for therapeutic area scientists and provides mentoring and/or training on clinical documentation and submission planning to individuals or teams. Ideally, proactively identifies medical writing training needs for staff and develops/implements training sessions.

• Has ability to prioritise effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor\xe2\x80\x99s Degree

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD, PharmD, MPH, MS or other post-graduate degree
• Possesses highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
• Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
• Experience analysing complex scientific & operational information and implementing effective solutions.

Why GSK?

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 \xe2\x80\x93 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.

• This is a job description to aide in the job posting, but does not include all job evaluation details.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. 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 organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. 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.