Medical Writer for part time position - 50%
פוליפיד בע"מ
- 09/01/2025
- פתח תקווה
The Medical Writer will be responsible for creating, reviewing, and managing clinical and regulatory documentation.
Writing and reviewing clinical study documents (e.g., Protocols, IBs, CSRs, SAPs, etc.).
Writing the clinical parts of regulatory submissions (e.g., INDs, NDAs) and responses to regulatory agencies.
Drafting publications, abstracts, posters, and presentations for medical and scientific conferences.
Creating educational materials for internal and external stakeholders.
Working closely with clinical operations, medical, regulatory, pharmacovigilance, and data management teams to review and interpret clinical data.
Incorporating data outputs, tables, and figures into clinical and regulatory documents.
Participating in team meetings and contributing to data -driven decision-making processes.
Writing and reviewing clinical study documents (e.g., Protocols, IBs, CSRs, SAPs, etc.).
Writing the clinical parts of regulatory submissions (e.g., INDs, NDAs) and responses to regulatory agencies.
Drafting publications, abstracts, posters, and presentations for medical and scientific conferences.
Creating educational materials for internal and external stakeholders.
Working closely with clinical operations, medical, regulatory, pharmacovigilance, and data management teams to review and interpret clinical data.
Incorporating data outputs, tables, and figures into clinical and regulatory documents.
Participating in team meetings and contributing to data -driven decision-making processes.
Requirements:
BA degree in life science (preferred Graduate MSc, PhD, MD, or PharmD degree).
Familiarity with ICH-GCP, FDA, EMA, and other global regulatory requirements (advantage).
Basic knowledge of statistical concepts and ability to liaise with biostatisticians.
Experience with EDC systems (e.g., Medidata Rave, etc.).
ICH-GCP training.
Minimum of 3 years of experience in medical writing.
Excellent written and verbal communication skills in English.
Previous experience in the pharmaceutical or biotechnology industry.
Strong attention to detail and organizational skills.
Proven ability to prioritize tasks and ensure timely delivery of high-quality documents.
Strong experience in Microsoft Office: Word, PowerPoint, and Excel.
Knowledge of reference management tools (e.g., EndNote, etc.).
BA degree in life science (preferred Graduate MSc, PhD, MD, or PharmD degree).
Familiarity with ICH-GCP, FDA, EMA, and other global regulatory requirements (advantage).
Basic knowledge of statistical concepts and ability to liaise with biostatisticians.
Experience with EDC systems (e.g., Medidata Rave, etc.).
ICH-GCP training.
Minimum of 3 years of experience in medical writing.
Excellent written and verbal communication skills in English.
Previous experience in the pharmaceutical or biotechnology industry.
Strong attention to detail and organizational skills.
Proven ability to prioritize tasks and ensure timely delivery of high-quality documents.
Strong experience in Microsoft Office: Word, PowerPoint, and Excel.
Knowledge of reference management tools (e.g., EndNote, etc.).
This position is open to all candidates.
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