Freelance - Regulatory Medical Writer Milano

Freelance - Regulatory Medical Writer
Milano
Lombardia, Milano

IQVIA Italia is currently looking for a **Freelance **to support the _Italian Regulatory & Pharmacovigilance team _in medical writing activities.

Regulatory medical writing pertains to developing a **set of standard documents (regulatory dossier)** as evidence in support of quality, safety, and efficacy of a **product** required to be submitted by an **applicant **to the appropriate **regulatory authority **for seeking **clinical trial** or **marketing authorization** of the product to be sold in the **market **for its **intended use**.

These documents should comply with the applicable **regulatory guidelines.

**Role and Responsibilities

- Evaluation and writing of CTD Module 2, 5

- Evaluation and writing of clinical documentation for medical devices

- Patient Narratives and Safety Reporting

- Annual Reports/DSURs/PBRERs

- Bibliographic search

- Gap analysis of the clinical data of registration dossier for medicinal product and medical devices with review versus current EU relevant regulatory requirements and, where applicable, versus company documentation

- Identification of gaps and of the clinical regulatory strategy to support registration

- Medical evaluation of promotional and non-promotional materials

- Ensure compliance to European and Italian legislation and regulations and supporting content development with authentic and up-to-date references.

**Experience Requirements

- Backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory) provide support to the world's largest pharmaceutical companies.

- Validated regulatory medical writing experience from within the pharmaceutical industry

- Strong understanding of the clinical drug development process with experience in integrating information from all phases of clinical development into clinical-regulatory documents/submissions

- Extensive knowledge of current regulatory guidelines relating to regulatory communications

- Ability to review a statistical analysis plan, identify deficiencies, errors, and inconsistencies in statistical output

- Ability to integrate, interpret, and summarize data from various sources in a clear and concise manner.

- In-depth knowledge of drug development, medical writing, and associated regulations, as well as statistical principles and medical terminology across a range of therapeutic areas.

**Technical Requirements

- Bachelor's Degree in life sciences-related discipline or related field (required)

- Master's Degree and/or Ph. D. in life sciences-related discipline or related field (preferred)

**Skills and Abilities

- Excellent written and oral communication skills in Italian and English, including grammatical/technical writing skills

- Attention to detail and accuracy

- Confident and effective communication and negotiation skills with customers and project managers

- Initiative and sound judgement when faced with unfamiliar project/document situations or challenges

- Ability to collaborate with others and demonstrate independent thought

- Confidence and maturity in most routine medical writing situations

- Ability to establish and maintain effective working relationships with co-workers, managers and customers

- Ability to effectively manage multiple tasks and projects

- Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers

Type of collaboration: Freelance (with Italian Partita Iva)

Collaboration from remote