Planet Pharma
Associate Director of Regulatory Medical Writing-615901
Planet Pharma, Boston, Massachusetts, United States,
Planet Pharma's biopharma client is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department.
This individual will contribute to and execute the overall strategy for all medical writing processes to according company medical writing standards standards and corporate objectives.
Roles and Responsibilities:Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documentsAuthor clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and that complies with applicable company SOPs, style guide, lexicon, templates, and librariesMay include roles that are key technical or subject matter experts providing professional or thought leadershipLooks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectivesCollaborates with clinical project teams, including program leader, clinical study managers, biostatisticians, medical directors, to ensure project deadlines are metResponsible for inspection-readiness of medical writing activitiesResponsible for medical writers assigned to support the medical writing activities for a particular projectEstablishes operational objectives, policies, procedures, and job aidsExecutes corporate objectives, goals, measures, and strategies; and begins to inform the development of themMay delegate work assessments
Desired Skills and Experience:PhD requiredMinimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience consideredNative/bilingual or fluent American English proficiencyFamiliarity with FDA and ICH guidelines for clinical reportingFamiliarity with pharmacovigilance documents preferredeCTD development, publishing, and submission experience preferredTherapeutic experience in biologics preferredBasic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submissionAbility to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)Ability to proofread documents for compliance with internal and external guidance documentsAbility to approach issues from various perspectives and accurately summarize data to provide conclusionsAbility to work precisely according to procedures and regulationsExcellent written and verbal communication skillsAbility to prioritize and multi-task successfully in a fast-paced environmentAbility to work autonomously, as well as collaboratively in a teamExcellent time management skills and a proven ability to work on multiple projects at any given timeMust be proficient in MS Office
This individual will contribute to and execute the overall strategy for all medical writing processes to according company medical writing standards standards and corporate objectives.
Roles and Responsibilities:Manage medical writers (in-house FTEs and contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documentsAuthor clinical content and project manage SME contribution of regulatory documents to develop content for regulatory submissions that is well-organized, consistent, accurate, and that complies with applicable company SOPs, style guide, lexicon, templates, and librariesMay include roles that are key technical or subject matter experts providing professional or thought leadershipLooks beyond existing methodologies and own discipline to define and resolve complex problems in areas critical to the achievement of objectivesCollaborates with clinical project teams, including program leader, clinical study managers, biostatisticians, medical directors, to ensure project deadlines are metResponsible for inspection-readiness of medical writing activitiesResponsible for medical writers assigned to support the medical writing activities for a particular projectEstablishes operational objectives, policies, procedures, and job aidsExecutes corporate objectives, goals, measures, and strategies; and begins to inform the development of themMay delegate work assessments
Desired Skills and Experience:PhD requiredMinimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience consideredNative/bilingual or fluent American English proficiencyFamiliarity with FDA and ICH guidelines for clinical reportingFamiliarity with pharmacovigilance documents preferredeCTD development, publishing, and submission experience preferredTherapeutic experience in biologics preferredBasic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submissionAbility to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)Ability to proofread documents for compliance with internal and external guidance documentsAbility to approach issues from various perspectives and accurately summarize data to provide conclusionsAbility to work precisely according to procedures and regulationsExcellent written and verbal communication skillsAbility to prioritize and multi-task successfully in a fast-paced environmentAbility to work autonomously, as well as collaboratively in a teamExcellent time management skills and a proven ability to work on multiple projects at any given timeMust be proficient in MS Office