What are the responsibilities and job description for the Clinical Medical Writer (Remote) position at Actalent?
Global biopharmaceutical company dedicated to developing and commercializing innovative drugs bringing on a fully remote Sr. Medical Writer!
Description:
Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. The Medical Writer will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission.
Medical writer will be responsible for the following:
- Partner with clinical teams to understand the nature of the scientific work that they will be covering.
- Conduct comprehensive literature searches to enhance their background understanding, then evaluate, analyze, and apply to clinical documents.
- Compile, write, and edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies.
- Deliver clinical documents including comprehensive clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
Job Requirements:
- Medical Writer must be aware of current industry practices and regulatory requirements that affect medical writing. They must keep abreast of current literature, emerging science, technological developments, and medical trends.
- Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in document types under supervision.
Additional Skills & Qualifications:
Experience / Education
- Bachelor’s degree in life sciences; Masters, PhD, PharmD desirable.
- Minimum of 3-5 years of experience in the pharmaceutical or related industry, with relevant Oncology and/or Non-Oncology (cardiovascular, respiratory and immunology) publication writing experience specific to CSS, CSP, CSR, IP, and regulatory package documentation.
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
