Freelancer profile translated to English.

Description

I seek to identify, understand, and retain your target audience (B2B or B2C).

My initial training and experience also allow me to transform your R&D needs into health products for B2B, where Pharma/Mass Market.

My 10 years of experience have allowed me to develop: a software medical device for cancer diagnosis, sterile syringes with hyaluronic acid for aesthetic medicine, a wide variety of cosmetic products including niche products, bandages, and medications.

My experience allows me to audit your operations, manage complex company projects, as well as M&A.

In summary: R&D - PMO - Marketing, for the benefit of the pharmaceutical and Medtech industries.

Languages

French
Native or bilingual
English
Fluent
Turkish
Basic

Workplace preferences

Can work on-site

Paris (up to 50km)

HRA Pharma
New Product Development Manager
PHARMACEUTICALS INDUSTRY
July 2019 - March 2024 (4 years and 7 months)
Paris, France
- Development of 2 sterile bandages - including cross-functional project management, risk analysis according to ISO;
- Maintenance of Technical File and DHF for Medical Devices, including CE certification/renewal audits;
- M&A for Mederma: both CMC and Cosmetics;
- Tech transfer for 1 hydrogenated body fat product from Switzerland to France;
- Management of multiple complex projects;
- Scientific Officer of the BU for press releases/communication;
- Stability acquisition for MD products and compliance with MDR 2017/045 regulation for MDs
Project manager Bandages OTC Drug Regulatory Affairs
Filorga
Scientific Project Manager
PHARMACEUTICALS INDUSTRY
August 2016 - July 2019 (2 years and 11 months)
Paris, France
- Product formulations;
- R&D testing: in-vitro, ex-vivo and clinical studies (protocol, CER for MDs)
- Development of the CRO network;
- KOL management;
- Active participation in congresses: EADV, In-Cosmetics, Cosmetic 360…
R&D Cosmetics Technical writing Technical files Scientific valorization
Nodéa Médical
R&D / Clinical Research
BIOTECH
March 2015 - August 2016 (1 year and 5 months)
Villejuif, France
- Development of minimally invasive medical devices for breast cancer;
- Management of clinical research: sites, partners, data (audits, analyses…);
- Elaboration of IC documents: protocol, CER
Clinical research Medical devices QMS Audit medical writing