Senior Medical Writer

Senior Medical Writer (M/F/d)-230005DW

**Applicants are required to read, write, and speak the following languages***: English

**Preferred Qualifications**

Oracle Germany are looking for a Senior Medical Writer who has experience writing regulatory & safety documents.

**MISSON**:

- Compile, write, and edit medical writing deliverables covering all phrases of clinical research for submission to regulatory agencies.
- Creation of documents, point of contact for clients, writes simple proposals and methodology sections of more complex proposals with input from Team Leader
- Writing of study reports for non-interventional and clinical studies
- Write scientific copies for a broader audience, including scientific liaisons, healthcare professional, and pharmaceutical representatives.
- Creation of components of submission dossiers dossiers (modules of the Common Technical Document [CTD]), and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
- Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
- Develops relationships with clients and is considered a point of contact by clients for project requests / questions
- Writes simple proposals and methodology sections of more complex proposals with input from Team Leader Medical Writing or Directors
- Prioritizes workload with mínimal input from Team Leader Medical Writing to ensure agreed deadlines are met
- Manages workload of their self and others to ensure that agreed deadlines are met
- Develops own knowledge and personal skills in line with business requirements
- Provides expertise to internal and external stakeholders to ensure all materials and publications comply with relevant SOPs, regulations and guidelines.
- Demonstrates maturity in the assessment of own learning and development needs
- Keeps abreast of developments in the pharmaceutical industry
- Identifies and develops new ways of working to ensure continuous business improvement
- Preparation of other project-specific documents such as observational plans and study protocols
- Ensure all deliverables are in accordance with regulations, standards, and guidelines.
- Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze information covered in the writing.
- Prepare abstracts, scientific exhibits, posters and verbal presentations.
- Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations.
- Compile, write, and edit medical writing deliverables covering all phrases of clinical research for submission to regulatory agencies.
- Creation of documents, point of contact for clients, writes simple proposals and methodology sections of more complex proposals with input from Team Leader
- Writing of study reports for non-interventional and clinical studies
- Write scientific copies for a broader audience, including scientific liaisons, healthcare professional, and pharmaceutical representatives.
- Creation of components of submission dossiers dossiers (modules of the Common Technical Document [CTD]), and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
- Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
- Develops relationships with clients and is considered a point of contact by clients for project requests / questions
- Writes simple proposals and methodology sections of more complex proposals with input from Team Leader Medical Writing or Directors
- Prioritizes workload with mínimal input from Team Leader Medical Writing to ensure agreed deadlines are met
- Manages workload of their self and others to ensure that agreed deadlines are met
- Develops own knowledge and personal skills in line with business requirements
- Provides expertise to internal and external stakeholders to ensure all materials and publications comply with relevant SOPs, regulations and guidelines.
- Demonstrates maturity in the assessment of own learning and development needs
- Keeps abreast of developments in the pharmaceutical industry
- Identifies and develops new ways of working to ensure continuous business improvement
- Preparation of other project-specific documents such as observational plans and study protocols
- Ensure all deliverables are in accordance with regulations, standards, and guidelines.
- Conduct comprehensive literature searches to enhance background understanding and evaluate and analyze information covered in the writing.
- Prepare abstracts, scientific exhibits, posters and verbal presentations.
- Develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations.
-