Principal Medical Writer/PA or NJ Location

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.This is a position for an experienced medical writer who is able to take responsibility for projects and for summary submission documents. This position will create clinical documentation according to company guidelines and international government regulations that will present clinical data in a clear, concise format. The incumbent must show leadership in writing, editing, and reviewing clinical study reports and other clinical regulatory documents.Duties and Responsibilities
Prepare clinical documents and ensure their timely completion, according to company SOPs and guidelines, with the ultimate aim to gain regulatory approval of therapeutic indications.
Prepare Phase I, II, III clinical study reports with no supervision.
Lead team in completing, or complete major submission documents (e.g. pivotal study reports or summary submission documents, such as Clinical Expert Report, ISS, ISE, CTD).
Ensure a consistent style of presentation of the clinical documents to maintain quality.
Review and edit work of contract writers to ensure quality is maintained.
Participate in a series of defined meetings with physicians, biostatisticians, pharmacovigilance representatives, and pharmacokinetic and regulatory personnel, regardless of location, to ensure correct focus of the clinical documents and to coordinate comments of reviewers.
Maintain adequate records for metrics and tracking to monitor progress of clinical documents and to keep management informed of progress and potential delays to maximize efficiency within the department.
May have responsibility as Lead Writer, for MW activities for several projects, including larger projects and high-priority projects.
May direct activities of other medical writers to ensure quality and consistency.
May have or share responsibility, as Therapeutic Area Leader, for MW activities for a clinical therapeutic area.
Participate in developing timelines and estimating resource needs for large, complex documents.
Lead task force concerning process improvement.
Contribute to mentoring more junior members of the department.
REQUIREMENTS
Knowledge and Skills
Strong skills in teamwork, problem-solving, communication (written and spoken English), and the ability to communicate with more senior personnel is required.
Demonstrated leadership in setting timelines for document completion and directing others (inside and outside MWG) to complete high quality documents on time is required.
Demonstrated ability to prioritize tasks, to work on multiple projects simultaneously, to meet timelines, and to ensure high quality is required.
Technical expertise with electronic document management and word processing software is required.
Ability to interpret complex pharmacokinetic and statistical data is required.
Advanced knowledge of medical terms and clinical trial methodology is required.
Knowledge of regulatory guidelines (e.g. ICH) for preparation of summary submission documents is required.
Excellent interpersonal skills (e.g. diplomacy, tact) listening skills, and the ability to maintain a positive attitude are required.
Ability to work effectively in a multicultural, multilingual setting is required.Formal Education/Experience
A Ph.D, in life sciences, or equivalent experience, and 2 or more years relevant work experience or a BS/MS and 5 or more years relevant work experience are required.
Work experience must be in, or directly related to, medical writing.Knowledge and Skills Desirable but not Essential
Competence in written and oral French.