Join Mondelēz as a Full Time Nabisco Merchandiser/Order Writer. Oversee store product merchandising through shelf stocking and promotional displays across various locations.
About the role
- Director Medical Writing Asset Lead at GSK, providing medical writing strategy and ensuring high-quality clinical documents for regulatory submissions.
Responsibilities
- 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.
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.
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