SMART IMMUNE is a clinical research-stage biotechnology company that develops cell therapies derived from T cell progenitors through an innovative platform called ProTcell. These new-generation cell therapies allow in record time the « reset » of an immune system capable of effectively fighting cancers and infections, significantly improving the prognosis and quality of life of patients.

In order to support our growth, we are looking for a medical/scientific writer.

More informations : https://www.smart-immune.com

Missions :

The medical/scientific writer participates in the development of clinical and medical documents, scientific documents, analytical documents and regulatory documents of high quality, by preparing and coordinating the development of these documents or by contributing to documents developed by d others, by an active contribution. He participates in the design of scientific and clinical biostatistical studies.

He/she will be responsible for, in particular:

·       Write, review and edit various clinical and/or medical documents for the submission and/or approval of pharmaceutical products and in support of other SMART IMMUNE departments, including research and development, regulatory affairs, pharmacovigilance and program management (e.g. clinical study protocols, Brochures, DSUR, clinical overview, investigation plan, clinical safety reports, briefing materials for regulatory authorities and advisory committees);

·       Oversee document review cycles, including incorporating team feedback and leading document review and finalization discussions;

·       Participate in the statistical design of scientific and clinical studies

·       Lead the development and maintenance of templates and standard operating procedures related to scientific writing;

·       Review documents issued by other departments, including ICFs, product handling manuals.

·       Follow up on relevant literature using different sources;

·       Act as daily point of contact for other departments for all scientific and medical writing activities by assisting with clinical working groups, providing timelines to meet with global clinical working group or regulatory deadlines, and coordinating the development of all documents.

·       Identify, communicate and resolve issues impacting document timelines;

·       Create precise, understandable documents adapted to the target audience;

·       Comply with accepted and standardized written and regulatory guidelines and internal guidelines.

Profile

Desired education: PhD in life sciences, biological sciences or a related field.

Desired experience: 5 years of experience in a pharmaceutical company (sponsor and/or CRO).

Is appreciated :

– Experience with EU and US regulatory documents

– Experience in immunology and oncology is a plus

– Mastery of biostatistics, design of experiments (DoE).

Written and spoken English is essential

Skills & Competencies

• Rigorous in the use and referencing of data;

• Flexibility and sensitivity to tight and difficult delivery deadlines;

• Strong organizational and time management skills;

• Ability to manage priorities.

To apply, please send your application (CV + cover letter) by email to Estelle Dorey, HR department: hr@smart-immune.com

L’article MEDICAL/SCIENTIFIC WRITER H/F CDI est apparu en premier sur OncoSTART.

Damae Medical is reinventing skin imaging, revolutionizing the screening, management, and follow-up of skin cancers (melanoma and carcinoma) with its deepLive™ solution, which provides an accurate, fast and reliable optical examination without performing a biopsy.

CE marked, the deepLive™ medical device is based on LC-OCT (Line-field Confocal Optical Coherence Tomography) proprietary optical imaging technology that provides 3D images of the different layers of the skin at the cellular level, complemented by several software and Artificial Intelligence (AI) modules. This innovation is protected by 6 patent families and has already been published in more than 70 scientific and medical publications.

Present in 10 countries and used in more than 30 world leading centers, deepLive™ transforms the daily practice of dermatologists making the management of skin pathologies efficient, reassuring, and non-invasive for the patient. The product is also used by leading cosmetic and pharmaceutical players for research and evaluation purposes.

Based in Paris, Damae Medical currently employs 30 people driven by innovation and continuous improvement. Winner of several innovation awards (MIT Technology Review, Bpifrance, European Commission), the company has been able to invest more than €20 million since its creation in 2014.

Welcome to a world where you can see beyond appearances!

Join us as Customer Success Specialist!

Among the Marketing Team, you play a key role to shape our value, create a better understanding of the Skin Imaging market and ensure customer adoption through very broad responsibilities.

What will you do?

·         Build a success plan for our customers, tailored to their practice and KPIs

·         Guide our clients to an optimal use of our solutions. Help them surpass their objectives. Measure the value generated. Grow each individual account to expand adoption

·         Manage, develop and maintain our customer portfolio. Identify at-risk customers to minimize churn. Identify accounts that don’t use our product to the maximum by analyzing data. Drive renewals.

·         Gather and communicate customer feedback to the Product team

·         Encourage our customers to become references through public speaking events, co-creation projects. Share information about our customers. Ensure that our customers know how to use our products

·         Participate to the improvement of our practice: update & creation of new processes, methodologies, documentation, content for our clients, etc.

Full job description here: www.damae-medical.com/files/22005.pdf

Apply via email with reference 22 005 to job@damae-medical.com

L’article CUSTOMER SUCCESS SPECIALIST est apparu en premier sur OncoSTART.