Senior Medical Writer
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading Pharmaceutical company is hiring a Senior Medical Writer on a contracting basis.
Work Location: Summit NJ
- Must have a strong scientific background and experience in writing manuscripts for publication in peer-reviewed journals
- Develop, manage and execute publication plans of one or more therapeutic areas in support of clinical programs in Hematology/Oncology
- Responsibilities include timely and efficient planning, development, and submission of manuscripts, abstracts, and scientific meeting presentations, in partnership with company teams (scientists, study investigators, other writers and medical communications) and publication vendor
- Assisting in preparation of other scientific documents, including clinical and non-clinical study reports, as well as preclinical and translational sections for regulatory submission dossier
- Possess an understanding of pre-clinical development and translational sciences, including biomarkers, and working knowledge of basic medical statistics
- Collaborate with translational scientists and representatives from various scientific disciplines (Hematology/Oncology, Pharmacology, Drug Metabolism & Pharmacokinetics) to develop, manage and execute publication plans with a focus on preclinical development and translational sciences
- Contribute to the development, review, approval, and submission of manuscripts for publication in peer-reviewed journals and at key independent medical and scientific congresses
- Review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation
- Assist in the preparation of other scientific documents, including clinical and non-clinical study reports, preclinical and translational sections for regulatory submission dossier
- As needed, review work of other writers for accuracy, quality, focus, and adherence to format and stylistic requirements in order to ensure high quality documents
- Assist in statistical analysis of clinical and non-clinical data for presentation
- Advanced degree in biology, pharmacology, or related science (MS or PhD)
- At least 3 years of experience in writing scientific publications, abstracts, reports and/or review articles in biological or pharmaceutical research related fields
- Excellent technical scientific writing skills
- Knowledgeable in preclinical development and translational sciences, including biomarkers
- Demonstrated ability to compile concise and accurate summaries of complicated data sets
- Working knowledge of basic medical statistics
- Proficiency in use of Microsoft Word, Excel, Adobe Acrobat, data graphics software, and Spotfire
- Advanced knowledge of and compliance with Good publication practices and ICMJE guidelines
- Demonstrated ability to work on multiple projects efficiently and in a timely manner.
- Ability to work within cross-functional teams.
- A MS or PhD degree in a field of biology, pharmacology or related field with 3-5 years scientific writing experience