Snr Medical Writer (m/f/d)

Beschreibung

We are currently looking for a senior medical writer (m/f/d) for our pharmaceutical client

Start: 02.08.2021
End: 31.12.2021
Volume: fulltime
Location: remote / Monheim
Language: German and English

Scope:
1-3 protocols and study reports (CSRs); summary documents (including Integrated Summary of Safety [ISS], Integrated Summary of Efficacy [ISE], Overview, Summary), risk management plans (as needed), and study summaries (for posting to study registries); and parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, IND, and EU Annual Safety Updates, and responses to agency questions; and other documents that may be assigned.

Responsibilities:
* Ensure critical review and interpretation of efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation.
* Prepare submission documents for a regulatory audience, within a team environment, according to the clients SOPs and templates.
* Manage review and approval process of submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers
* Participate in the of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards

Tasks:
* Write and prepare submissions documents within a team environment
* Ensure critical review and interpretation of efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation.
* Manage the review and approval process of submissions documents; notify team of targeted review responsibilities.
* Review and comment on documents in program associated with project assignments
* Act as Program Medical Writer (as assigned). Provide process, content, and planning expertise to Team, Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies
* Coordinate with other Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications.
* Maintain and demonstrate comprehensive knowledge of drug process and applicable regulatory guidelines
* Maintain and demonstrate knowledge of company- and project-specific guidelines for the generation of submissions documents, including SOPs, templates, and document writing conventions and styles
* Liaise with vendors/external contractors as assigned

Skills:
- Senior Medical writer experience within Pharmaceutical clients
- Strong work ethic
- Experience in creating study reports and protocols
- Experience with generating documentation for regulatory audience
- N2H: experience in therapeutical area
- Management and team lead experience
- Experience with drug process and related guidelines

Michael Bailey International is acting as an Employment Business in relation to this vacancy.