Apply Now

Senior Medical Writer (m/f/d)

Munich, Bavaria, Germany

Job Description

Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

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 minimal 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 minimal 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.

Working Environment

Hybrid or Remote

This position offers a Hybrid or Remote working environment. Meaning if you live within a metro area of a Cerner office, you will split working time between a Cerner office and remote. If you are not within a metro area of a Cerner office, you can live and work in your current geographical location and work primarily remote. #LI-Hybrid #Remote

Back to Description

Because It's Personal

Time: 2:57

Additional Information

Working Environment	Hybrid or Remote
Relocation Assistance Available for this Job:	No

Qualifications

Master's Degree in a life science subject and several years practical experience in Medical Writing
Experience within CRO, pharmaceutical or life science organization
Ability to collaborate with others efficiently
Ability to manage several projects at any one time
Able to work to tight deadlines

All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.

Cerner is a place where people are encouraged to innovate with confidence and focus on what is important – people’s health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.

Cerner’s policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.

If you are an individual with a disability who is unable to use our online tools to search and apply for jobs, and need assistance or an accommodation in the recruiting process, please contact us by calling 866-434-1543 or by emailing CernerCareers@cerner.com.

Senior Medical Writer (m/f/d)

Munich, Bavaria, Germany

Job Description

Working Environment

Because It's Personal

Additional Information

Qualifications

Related Positions

Team Lead - Pharmacovigilance (m/f/d)

Senior Biostatistician (m/f/d)

PV Officer – Medical Review (m/f/d)