Job Title:
Medical/Science Writer, Population Council
Full Time, New York, NY
JOB TITLE: Medical/Science Writer, Reproductive Health Program
REPORTING TO: Senior Manager, Global Medical Writing
LOCATION: Center for Biomedical Research, New York, NY
ASSIGNMENT LENGTH: 2 years, renewable by mutual consent and availability of funding
POSITION SUMMARY:
Under the direct supervision of Senior Manager, Global Medical Writing, and in collaboration with clinical scientists, the Medical/Science Writer will be responsible for expeditiously preparing clinical documents including protocols, clinical study reports (CSRs), Investigator Brochures (IBs), ISE/ISS documents, and other clinical documents in eCTD-ready format following the International Conference on Harmonisation (ICH) guidelines and regulations of the United States Food and Drug Administration (US FDA) as well as other regulatory authorities. The Medical/Science Writer will perform clinical document quality control activities and collaborate with safety and statistical staff regarding the presentation of safety and statistical data. The ideal candidate will be able to function independently and be familiar with eCTD compliance to write in a detail-oriented and organized manner.
RESPONSIBILITIES:
- Write and edit clinical documents such as protocols, CSRs, IBs, and ISE/ISS documents. Assist with assembly and editing of Investigational New Drug (IND), and New Drug Applications (NDAs).
- Ensures Council’s research efforts comply and adhere to eCTD requirements, clinical guidelines (ICH), government mandated regulations (FDA), and other regulatory entities as needed, regarding such documents as CSRs, protocols, standard operating procedures (SOPs), and templates.
- Manages and schedules reviews of draft documents from the content experts regarding all matters of medical and clinical relevancy and quality control (QC) by medical writing. Coordinates the collection and assembly of all appendices and referenced articles.
- Ensures the quality and timeliness for the completion of clinical documents by meeting established project timelines during the life-cycle development and release of these documents.
- Assists in providing continuity with respect to the presentation of statistical data by:
- collaborating with Statistics and Data Management to resolve errors and inconsistencies in clinical study data to be presented
- reviewing and providing feedback regarding the information, accuracy, and format required by regulations for the tables, listings, and graphs for inclusion in clinical documents, and
- serving as a member of the Statistical Analysis Plan (SAP) review
team to review and finalize the SAP.
- Provides additional editorial services as requested.
QUALIFICATIONS:
- Bachelor’s Degree in life sciences or related field (PhD, PharmD degree or MS degree preferred) or a satisfactory combination of education and relevant experience.
- At least seven years experience in medical/science writing.
- Documented writing and editing skills. Must have extensive prior experience in writing and editing eCTD-compliant clinical documents.
- Must have working knowledge regarding statistics and the roles that statistical data, graphs, and tables play with respect to the presentation of data in clinical documents.
- Proficiency in Microsoft Office and Adobe applications, and knowledge of publication of clinical document submissions. Experience in use/construction of document templates is essential.
- Must have strong interpersonal and communication skills, be able to prioritize and work independently, and have a proven record of quality written work.
- Knowledge of ICH, US FDA, other regulatory guidelines, and eCTD requirements.
The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of country offices. We are seeking an individual to fill the position described. If you know of a qualified candidate or are interested in this position, please apply at:
http://www.popcouncil.org/employment/index.asp.
The Population Council provides equal opportunity; it does not discriminate against any person with regard to age, color, creed, national origin, disability, political belief, veteran status, religion, marital status, gender, gender identity, or sexual orientation. Decisions on employment are based on an individual’s qualifications as related to the position for which s/he is being considered. The Council especially encourages applications from qualified women and members of minority groups. The Population Council is international in the composition of its board of trustees and its staff, as well as in the nature and deployment of its activities.
