Medical Writing – Senior Associate / Manager (Cork, Ireland)
Location: Cork, Ireland.
Our client, a multinational pharmaceutical company based in Cork, Ireland is looking for an experienced Medical Writer.
Working with cross-functional, multidisciplinary teams to facilitate external scientific publications (including but not limited to abstracts, posters, manuscripts, and presentations) and/or regulatory documents (including but not limited to protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications) is the objective of the Medical Writing – Manager (also known as Scientific Communications) role supporting Chorus.
Primary job tasks:
1. Document Preparation / Document Management: Role-based Training Plan (Medical Writer)
· Plan, write, edit, review, and coordinate the publication of scientific data through peer-reviewed journals and forums and/or regulatory documents.
· Facilitate trial development and product registration.
· Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
· Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in appropriate document management system.
· Exhibit flexibility in moving across development and preparation of multiple document types.
· Manage and track workload and escalate resource capacity issues as needed.
2. External Service Provider Management: Role-based Training Plan (Medical Writer)
· Build/manage relationships with vendors/alliance partners.
· Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management.
3. Knowledge and Skills Development: Role-based Training Plan (Medical Writer)
· Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project.
· Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
· Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
4. Knowledge Sharing and Consultant Support: Role-based Training Plan (Medical Writer)
- Provide peer coaching to others by sharing technical information, giving guidance, answering questions.
- Network with others (including other functions and regions) to identify and share best practices.
- Contribute to process improvements, suggesting opportunities where appropriate.
5. Customer Focus: Role-based Training Plan (Medical Writer)
· Work with internal and external speakers to develop and prepare presentations.
· Engage in activities supporting reward and recognition, team building, and diversity.
Support cross-functional coaching, mentoring, and training
Qualifications:
- Ph.D. in a scientific-related field: health/communications/health outcomes/health economics/public health, etc.
- Experience writing scientific publications.
- Clinical pharmacology, therapeutic area, or other medical and scientific-specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise).
- Experience in clinical trial processes or regulatory activities.
- Strong communication and interpersonal skills.
- Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)