Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization's potential and what we hope it will become.
Works with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development.
Manages all outsourced writing work.
Manages global clinical study transparency requirements (e.g. clinicaltrials.gov postings).
Contributes scientific knowledge, analytical skills, and insight to Clinical, Project Team, and Submission Team meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
Ensures a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
A scientific degree or Ph.D. in life sciences or PharmD is required.
Knowledge of clinical development processes is preferred.
Background suggesting the ability to clearly, accurately, and concisely prepare all types of simple documentation in English, e.g. scientific authorship experience, editorial experience, etc.
Experience as a Medical writer (preferably >3 years), or equivalent, or presenting relevant specialist qualifications (e.g., PhD). Knowledge of clinical development processes is preferred.
Background documenting a basic understanding of, preferably also experience in basic statistics and experimental research.
Excellent oral and written English.
Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
Ability to work autonomously and proactively.
Possesses a sense of urgency and is deadline oriented.
Works in an accurate, meticulous manner; is detail-oriented.
Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills
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Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.