Senior Medical Writer

Jobinhalt

Job summary:

• Submissions documents in scope include: 1-3 protocols and study reports (CSRs)
• Summary documents (including integrated summary of safety (ISS), integrated summary of efficacy (ISE), overview, summary), risk assessment plans (as needed), and study summaries (for posting to study registries)
• And parts of investigational drug brochures, agency meetings briefing packages, INDs, IND, and EU annual safety updates, and responses to agency questions
• And other documents that may be assigned

Is the responsibility of the senior medical writer to:

• 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 (IHC) compliant presentation
• Prepare submission documents for a regulatory audience, within a team environment, according to SOPs and templates
• Manage review and approval process of submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner
• Provide process, content and submission/document planning expertise to submission team, satellite team, and team
• Advise team on resource utilisation, efficiencies, timelines and interdependencies
• Participate in the 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 to foster open communication, quality, efficiency, and cost-effectiveness of document generation to support the delivery of high-quality documents within realistic and ambitious timelines
• Share expertise within medical writing and therefore across therapeutic areas

Major accountabilities:

• 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
• Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner
• Review and comment on documents in program (eg, protocols and statistical analysis plans) associated with project assignments
• Act as program medical writer (as assigned)
• Provide process, content, and planning to team, satellite team, and submission team regarding document preparation, submission strategy and consistent scientific messaging
• Advise team on medical writing resource utilisation, efficiencies, timelines, and interdependencies
• Oversee preparation of submission documents for a program, review and provide feedback on submission documents to maintain consistent content, managing and style
• Coordinate with other program medical writers and other medical writers as needed to maintain consistency across documents within a project and across indications
• Participate in the processes and tools related to authoring and reviewing of documents
• Continually share best practices in an effort to create higher quality documents more efficiently
• 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
• Ensure timelines and quality of product when the writing of a document is outsourced
• Such other responsibilities and projects as the company may assign

Our offer:

Consulting

We offer an attractive salary with extra-legal advantages :

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible

Our client:

Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.