A leading biotechnology company is seeking a Medical Writer to join their team in New Jersey, USA. The company is a leader in rare and orphan diseases.
The Medical Writer will focus on the preparation, assembly, writing, and review of the analyses and documentation needed in support of clinical programs and trials and corresponding submissions to regulatory authorities.
- Development and updating of Investigator's Brochures, Safety Update Reports, and other regulatory documents. .
- Preparation of clinical study protocols, clinical study reports or other regulatory documents supporting ongoing clinical development programs. Development of these document's supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements.
- Consolidation and evaluation of teammates' review comments to determine needed revisions
- Reviewing statistical analysis plans and accompanying table and listing shells for the evaluation and presentation of clinical trial data
- Quality-checking documents for agreement between in-text information and the source data, and for internal consistency
- Editorial review of documents for grammar, punctuation, and submission-compliant formatting
- Provide overall medical writing support for ongoing programs
- Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures) will be expected to perform the above functions.
- The candidate must be able to work independently and efficiently with cross functional team members.
- Bachelors degree in a scientific discipline plus a minimum of 5-7 years industry experience.
- Masters degree in a scientific discipline plus a minimum of 2-5 years industry experience.
- Ph.D, Pharm.D, or equivalent in a scientific discipline plus a minimum of 1-2 years industry experience.
- The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication.
- A good understanding of medical terminology and AMA style is needed.
- This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians. It will be essential to approach issues from a number of perspectives, summarizing data to draw a conclusion.
- The applicant would have previous experience in leading the writing of clinical/regulatory documents, such as protocols, investigator brochures, annual safety updates, and clinical study reports. as a lead author, this person must work cross-functionally with appropriate teammates to create documents, coordinate their review, and edit through finalization.
- Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat are needed.
- High attention to detail.
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A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.