Medical Writing Manager

**Date**:14 Jul 2025

**Department**:Global Clinical Development

**Business Area**:R&D, Pharmacovigilance & Regulatory Affairs

**Job Type**:Direct Employee

**Contract Type**:Permanent

**Location**:Parma, IT

**_About us_**
- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas**:Discover more here**
- We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**, a recognition of **high social and environmental standards**. We are a **reliable** company that adopts and promotes a **transparent and ethical behavior** at all levels.
- We believe that the success of **Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors**. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
- In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

**_Chiesi Research & Development_**
- Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

**_Who we are looking for_**

**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 er