Site Name: Belgium-Wavre, Italy - Siena
Posted Date: Sep 6 2024
Job purpose:
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. Your responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: You provide key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents like protocols, clinical study reports, clinical study register summaries, common technical document summaries and Clinical Overview among other documents.
You lead matrix teams in planning and production of multiple clinical documents to support regulatory submissions, working with CROs and/or independent contractors as needed.
You ensure 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.
You plan and successfully implement large submissions independently or in conjunction with the Medical Writing Director, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary.
You demonstrate an understanding of the interdependences of various contributing functions and manage problems affecting timelines as necessary.
You demonstrate an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.
You propose resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.
You effectively organize content and argument in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.
You actively contribute to development of training materials for therapeutic area scientists and provide mentoring and/or training on clinical documentation and submission planning to individuals or teams.
You have the ability to prioritize 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?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals: Master's degree in any scientific related field
Hands on experience with medical writing and clinical regulatory document is a must
Demonstrated experience managing multiple strategic partnerships
Experience or exposure to submission documents
Great sense of leadership in order to guide people
Outstanding communication skills to interact with different stakeholders
Fluency in English is a must, any other language is an asset
Ability to evolve in a matrix environment
Preferred Qualifications & Skills:
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.
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