Director Medical Writing Asset Lead

These responsibilities include some of the following:

• Providing key contributions to clinical document strategy for one or more assets throughout the life cycle of drug development. Documents in scope include but are not limited to clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions.

• Leading matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed.

• Planning and successfully delivering large submissions independently, effectively recommending innovative methods and solutions for achieving accelerated timelines. Assessing and adapting to interdependences of various contributing functions and managing problems affecting timelines as necessary. Ensuring a global approach for submissions as appropriate, collaborating with Global Regulatory Affairs to ensure business needs and regulatory requirements are met. Providing guidance and facilitation to submission teams in development of detailed submission plans.

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

• Proposing resourcing solutions for major projects including the number of FTEs required and best use of internal and external resources.

• Actively contributing to development of training materials for therapeutic area and providing mentoring and/or training on regulatory requirements, medical writing processes, and submission planning to individuals or teams.

• Driving, promoting and implementing key organizational process improvement initiatives.  Proactively generating ideas for simplification and improvement taking advantage of opportunities that arise and challenging the status quo. Incorporating, promoting and encouraging the adoption of technology for clinical documents within medical writing and the stakeholder landscape.

• Prioritizing and meeting multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix.

• Promoting leadership behaviors that support GSK values.

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

• PhD, PharmD, MPH, MSc, or other post-graduate degree

• Substantial experience in clinical regulatory writing and

in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.

• Strong experience in project management, planning, communication, and demonstrated matrix leadership to deliver results

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

• Experience in delivering accelerated submissions for EU, US, China, Japan and Rest of World.

• Experience in Hepatology therapy area.

• Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.

• Excellent understanding of clinical operations / medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval.

• Strong strategic and critical thinking, problem solving, influencing and decision-making capabilities.

Working arrangements This role has a hybrid working model. You will work on-site 2/3 days per week as agreed with your manager to support collaboration and team needs.