Director, Medical Writing Asset Lead

Role Overview

• 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’s Brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overviews, 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.
• 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.

Requirements

• Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline.
• Extensive experience in clinical regulatory writing in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.
• Extensive experience in project management, planning, communication, and demonstrated matrix leadership to deliver results.
• 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.

Tech Stack

• Google Cloud Platform

Benefits

• All statutory benefits will be maintained in accordance with Polish law.
• Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.