Senior Medical Writer - Munich, Deutschland - Oracle

Oracle

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Senior Medical Writer (M/F/d DW

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 noninterventional 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 projectspecific 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 noninterventional 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 projectspecific 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.