Regulatory & Medical Writer (Pepgra)

Roles and Responsibilities

What you will do

• Regulatory writing in compliance with EU and US standards and protocols.

• Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables.

• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical R&D, Sales and Marketing, Library Services, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).

• Provide strategic guidance on regulatory requirements to new product development teams and sustaining teams.

• Write, edit clinical study protocols, clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.

• Write, edit preclinical summary documents.

• Manage document reviews.

  • Support technical/clinical/regulatory writing for global regulatory submissions in electronic format.

  • Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other appropriate regulatory guidelines. Ensure compliance with company or client SOPs and style guidelines.

  • Write and maintain Standard Operating Procedures and Style Manuals for internal process and external process.

  • Prepare manuscripts, review articles, abstracts, posters and presentations in support of company programs according to International Committee of Medical Journal Editors (ICMJE) standards and requirements.

  • Quality audit all documents prior to publishing.