MAIN RESPONSIBILITIES

  • Contribute to Medical Affairs & Medical Writing activities within the Safety & Medical Platform and services to customers.
  • Prepare and review the CTD modules 2.4 and 2.5, 2.6, 2.7, module 4 and module 5 (CTD summary documents)
  • Prepare, reviews and provide feed-back for safety reports including: Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Risk Management Plans (RMPs) and Addendum to Clinical Overviews (ACOs)
  • Support the Platform Leader in the preparation of toxicology assessment.
  • Support the preparation of Investigator Brochures, Clinical Study Reports, INDs, NDAs
  • Contribute to the production of client administrative documents to be included in regulatory submissions (i.e. Briefing packages to HAs, Ethics Committees documentation).
  • Support the preparation of abstracts and/or scientific exhibits, posters and presentations.
  • Assist the Safety and Medical platform leader and other project staff in the generation of project related documents.
  • Assist in the preparation of Standard Operating procedures (SOPs) and Working Practice Documents.
  • To ensure adherence to GCP, ICH guidelines, SOPs, and client templates.
  • Understand and interpret clinical and scientific reports to allow the accurate capture of safety and efficacy data. Interpret and present scientific data, analyses and appraise clinical, biomedical and scientific reports in a systematic, accurate, fair and balanced way.
  • Reviews promotional materials.
  • Contribute to Medical Affairs & Medical Writing activities.

    • Prepare and review the CTD modules 2.4 and 2.5, 2.6, 2.7, module 4 and module 5 (CTD summary documents) MUST

    • Involved in preparation of Clinical Study Protocol, Study Reports, Investigator Brochures, IMPD, INDs, NDAs MUST • Support in drafting of SPCs, PILs, CCDS.

    • Contribute to the production of client administrative documents to be included in regulatory submissions (i.e. Briefing packages to HAs, Ethics Committees documentation).

    • Support the preparation of abstracts and/or scientific exhibits, posters and presentations.

    • Understand and interpret clinical and scientific reports to allow the accurate capture of safety and efficacy data. Interpret and present scientific data, analyses and appraise clinical, biomedical and scientific reports in a systematic, accurate, fair and balanced way.

    • Assist in the preparation of Standard Operating procedures (SOPs) and Working Practice Documents.

    • To ensure adherence to GCP, ICH guidelines, SOPs, and client templates. Education : PHD or Masters in Pharmacy/Bachelor in Pharmacy or life sciences with relevant experience / Medical doctor.

Required Experience

4 to 5 years of experience in CTD module writing and Clinical study document writing Required

Technical skills

Good scientific writing kills Fluent in English for daily communication Strong knowledge of ICH/GCP guidelines or other relevant clinical trial guidelines Teamplayer excellent organizational skills Ability to work both independently and in a team environment. Efficient in using Microsoft word, PowerPoint and excel.

Efficient in communication skills, English as well as Italian language

Medical Writer 566