top of page

Senior Medical Writer

Oncology and Immunology
 

  • Publications

  • Literature Reviews

  • Medical Communications

I help Biotech and Pharmaceutical Companies to transform innovative therapeutic data into impactful publications.

Specialization:

Antibody therapies - RNA therapeutics - Cell therapies - PCR diagnostics and Genome medicine

Do you know what that's like?

Phase II data are available, ...

but the team has no capacity for writing a manuskript

Complex mechanisms ...

must be understandable and convincing to reviewers

Congress deadline is in 6 weeks ...

but the abstract not finished

 

This is exactly where I can support you

With over 20 years of scientific expertise and industry experience, I transform your data into compelling publications - scientifically accurate, on time, and ready for publication.

Services

My Medical Writing Services

Manuscripts for High-Impact Journals.

Publication strategy, Viewing Data, Writing and Journal-Submission. Complete Manuscripts for international Top-Journals.

Timeline: 6-10 weeks

Systematic Literature Reviews

PRISMA-conform Literature Search and Analysis for regulatory submissions, and for health insurance providers and associations.  

​Timeline: 4-6 weeks

Abstracts und Poster for national and international Congresses.

 

Complete Solutions with Abstract, Submission, and crafting the Presentation.

Scientifically convincing and visual appealing Presentations that stand out.

Timeline: 2-4 weeks

Manuscript Review & Language Editing

Scientific Editing, Fact-Check, Language-Polishing (EN-DE, DE_EN). Also for Medical Information Content.

Flexibly available.

Services

Meine Services

Writing and Management
of Medical & Scientific Documents

 
Homepage Write Flow3.png

by Silke Rinkwitz, Life Science and Medical Writing

Services for Industry
Medical Writing
Scientific Writing
Systematic Literature Review
Management and Review

Review and Editing (EN-GER)
Fact-checking and Consulting

Drug Research  and Life Cycle

For Biotech, Pharma and Health insurances:

  • Research and Review Articles

  • Abstracts

  • Systematic Literature Reviews and Reports

  • Clinical Study Reports (CSRs)

  • Presentations

  • Submissions to journals and authorities

  • Management and Review (Veeva, iEnvision)

  • Plain Language Summaries (PPLS) 

  • Consultancy

Medical Content
and
Medical
Information

Screen Shot 2022-12-07 at 4.27.39 pm.png

Clinical Studies and Medical Information:

  • FAQ / Q&As, SRDs, and Guidelines

  • Informed Consent documents for patients participating in clinical studies

  • Plain Language Summaries (PLS, for CSRs)

Experience

My Experience

Patients

Pharma

CRO

Research

That's me: A well versed Medical Writer with a thorough med-scientific background in many therapeutic areas and international/global experience. Extensive Pharma and CRO experience with a comprehensive understanding of clinical studies, their design, and drug development regulation (GCP, ICH, and EMA guidelines; CSRs). Familiar with Medical Information and Content creation practices (SRDs, FAQs, Patient and HCP information) and Systematic Literature Review (PRISMA, EMA guidelines, SOTA). Experienced in manuscript writing and reviewing, in creating congress materials and in publication management. Scientific expertise in cellular and molecular therapies and diagnostics and the skill to translate this into German and plain language. Familiar with the structured workflow in pharmaceutical companies and MedComms agencies.

Professional Background:

Medical writer in a clinical research organization.

Regulatory affairs. Thorough understanding of the approval process, life-cycle management of drugs, and reporting. 

 

Medical communication, publication management, systematic literature reviews and report in global pharmaceutical and in vitro diagnostics industries. ​

Advanced academic research career with team lead and teaching in the Biomedical Sciences in Germany and Overseas. ​

Therefore:

  • I understand the purpose and requirements of my projects

  • I am scientifically accurate and pay attention to detail 

  • I am highly experienced in interpreting research data and am well versed in structuring and presenting it

  • I have excellent management and reviewing skills

  • I am experienced in international collaboration and correspondence

  • I know diverse audiences - authorities, researchers, patients

  • I am highly organised, structured and flexible in team work

 

... I am highly supportive of your projects!

​​​​

  • LinkedIn

Dr. Silke Rinkwitz

Sedanstraße 48

30161 Hanover

Germany

Phone:

+49-511-53071444

Affiliations:

EMWA Logo.png
Logo_proudmember2022.jpg

Impressum & Disclaimer:

VAT ID: DE352214902

Professional liability insurance: Hiscox, Arnulfstr. 31, D-80636 Munich; Coverage worldwide.

Privacy Policy (here)

Video and some images: Dreamstime

All content on this website are created by Silke Rinkwitz, and is subject to copyright law.

The distribution, processing, and reproduction of the content are not permitted.

This website contains links to external websites of third parties, on whose content I assume no liability.

bottom of page