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Duties

The Client Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. He/she/They coordinates directly with key stakeholders within organizations industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners).

• Key Responsibilities
• The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
• He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global organizations locations or contract manufacturing organizations (CMOs), or alliance partners. He/She/They identifies potential regulatory risks/challenges while ensuring Regulatory compliance.
• He/she/they authors autonomously the CClient sections of dossiers using organizations templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards. He/She/they ensures delivery of sections in a timely manner.
• He/she/they manages the writing of response to CClient questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
• He/she/they performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.He/She/They maintains an up to date knowledge of organizations ways of working and SOPs and develops a comprehensive understanding of global CClient regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
• He/She/They also authors other types of regulatory documents such as white papers, position papers, and briefing book.
• In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.

Skills and Experience

• The candidate must possess Chemistry, Manufacturing and Controls (CClient) and CTD experience. The candidate must have CTD Module 3 authoring skills. A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The candidate must have at least 5 years' experience in the pharmaceutical industry. Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus. A working knowledge of cGMP’s is desired. Experience with CClient documentation pertinent to various dosage forms and biological product is a plus.
• Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team. The candidate needs very little supervision, is capable of managing their priorities independently, is highly organized, and self-motivated. The candidate should enjoy writing. Knowledge of US pharmaceutical Regulations is essential. Exposure to ex-US Regulations is desired, but not mandatory.

Education

• BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).