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Job Description:
SMCI is seeking a Document Management Specialist to support development of regulated or process documents with the ability to deliver high quality documentation including technical writing. The primary responsibilities may include, but are not limited to the following:
Management of Research &Development (R&D) controlled process documentation per required process (e.g. Standard Operating Procedure [SOP] on SOPs) in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Development and facilitation of the creation and/or revision of materials such as SOPs and related business process documentation in conjunction with Subject Matter Experts. Note: these activities will usually take place virtually and across different time zones. Liaison with other members of the QCA group (e.g. Business Process Modelers) and also the business (e.g. Business Process Owner, Document Owner, Authors, Subject Matter Experts). Management of documents via the established R&D Document Review process using the electronic controlled document repository. Track and provide regular updates to process project plan and to key Points of Contact.
Requirements include: Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing. Proven project management and organizational skills. Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation. Experience in leading virtual teams within different regions and cultures. Proficient in discerning, high quality verbal and written communication. Experience of electronic clinical trial/SOP/document systems. Good working knowledge of Microsoft Word. 3+ years experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance.
Required Skills: BIOTECHNOLOGY; MS WORD; Electronic Clinical Trial/SOP/Document Systems.
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SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm.
(No third parties, please)
(H1 sponsorship currently unavailable)
(Local candidates only, please)
