Medical Writing Manager

Purpose

The Medical Writing Manager / Leader ensures efficient coordination and management of medical writing projects, overseeing planning, development, and completion of documents to meet regulatory and company standards.
This role requires excellent project management skills, a strong understanding of medical and scientific terminology, regulatory guidelines and landscape, and the ability to work collaboratively with global cross-functional teams involving stakeholders inside and outside the company.
Key responsibilities include managing critical deliverables such as protocol outlines, patient-facing materials, clinical study reports, sections of Module 2 of the eCTD, publications, posters, and abstracts, ensuring scientific accuracy and consistency.

Main Responsibilities

- Coordination and Management: Oversee the planning, development, and completion of medical writing projects, ensuring timely delivery and adherence to regulatory and company standards. This includes organizing and leading kick-off meetings, managing timelines, developing and maintain document templates, integrating content and feedback from different stakeholders, coordinating data collection, managing review cycles, ensuring regulatory compliance and quality control, supporting regulatory submissions, archiving documents, facilitating stakeholder communication, and resolving conflicts.
- Document Development: Coordinate the writing of informed consent and patient materials, protocol outlines/synopses, clinical study reports, applicable sections of Module 2 of the eCTD (electronic Common Technical Document), publications, posters and abstracts, ensuring scientific/medical/statistical accuracy, clarity, and consistency.
- Collaboration: Work closely with internal and external stakeholders (internal: clinical research physicians, clinical program leads, clinical project managers/leads, statisticians, data managers patient engagement partners, regulatory affairs, etc; external: CRO, Key Opinion Leaders, Patients experts and advocacy groups) to gather necessary information and ensure alignment on project objectives and timelines. This includes: facilitate stakeholder communication and resolve conflicts, coordinate definition of timelines and milestones for the different projects, data collection and support regulatory submissions.
- Innovation: Work with relevant internal and external stakeholders to assess the use and implementation of AI tools in the relevant activities and of electronic repository of information/data, to increase effectiveness and efficiency, and support the incorporation of new technologies and new approaches in Chiesi processes and procedures.
- Quality Control: Implement quality assurance processes to ensure that all documents are scientifically accurate and free of errors: review and edit documents for template control, content, grammar, and style, ensuring high-quality and scientifically accurate deliverables.
- Regulatory Compliance: Ensure all documents comply with the applicable regulatory guidelines and company policies, throughout the documents’ development process and to support regulatory submissions and ensure compliance.
Support the cross-functional Team working on Clinical Trials Transparency, with a particular focus on content development for posting in clinical trials registries, and the development of lay summaries and redacted documents.
- Project Tracking: Maintain detailed records of project timelines, milestones, progresses, and deliverables, providing regular updates to stakeholders. Coordinate final review and approval, publish results, and archive documents.
- Training and Mentorship: Provide guidance and support to junior team members, fostering a collaborative and productive work environment, in line with Chiesi Values and Behaviours.

Experience Required

Minimum of 5-8 years of experience in medical writing including as a Principal Medical Writer and project management within the pharmaceutical or biotechnology industry.

Education

Bachelor’s degree in life sciences, pharmacy, or a related field. Advanced degree (e.g. PhD) preferred.

Languages

fluency in english

Technical Skills

• Proficiency in medical and scientific terminology
• Excellent knowledge of healthcare compliance and other relevant guidance.
• Excellent knowledge of the clinical trials settings.
• Strong project management and organizational skills, with demonstrated capability to problem solve and mediate complex issues.

Soft Skills