icrc-weyer is an Owner-managed contract Research organisation and consultancy with a 24 years history, based in berlin. to our clients from the international Pharmaceutical and Medical Device sectors, we offer functional and Consulting services covering the product life cycle from Clinical Development to post-Marketing. medical and safety writing, Biostatistics and Data Management are among the core services of our portfolio. the satisfaction of our clients and the well-being of our employees are our top priority and the key to our success. you are invited to participate in that!
- preparing and writing of clinical documents (incl. csps, csrs, icfs, ibs and impds) and medical communication materials
- Planning, preparation, compilation and writing of pv documents for regulatory submission in the Clinical Development, market authorisation and post-Marketing phases such as rmps, pbrers and dsurs
- detail-oriented review of complex clinical and pv documents, assurance of consistency within and across documents
- Consulting and advice on contents and creation of clinical and pv documents
- management of projects and project teams incl. supervision and Coaching of junior writers
- input and liaison to Biostatistics and Pharmacovigilance
- communication with clients and regulatory authorities.
- very good understanding of clinical and Pharmacovigilance Data Analysis
- high proficiency in medical and scientific information retrieval
- very good understanding of Drug Development and pv processes and key regulatory requirements (incl. ich topics e2c, e2f, e3, e6 and EMA gvp legislation)
- very good knowledge of Medical Terminology
- high proficiency in ms office and reference management Software
- excellent verbal and written Communication Skills in German and English
- curiosity and willingness to acquire expertise in new fields with and without supervision
- 3 years of experience as a Medical Writer incl. demonstrated experience with pv documents
- University degree in a relevant discipline.
what we offer
we offer you to take a high degree of personal responsibility in a professional, friendly and diverse environment with flat hierarchies and opportunities for Personal Development, for participating in a committed team and learning from and with them, and for taking a look at the bigger picture together.
please forward your application documents incl. desired salary to firstname.lastname@example.org. we look forward to hearing from you! also, we are always interested in adding to our network of Freelance experts.
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