[Innovative Medicine] R&D, Manager, Japan Medical Writing, Regulatory Medical Writing, Global Development
Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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Position Summary: Able to write and coordinate basic and complex documents independently within and across therapeutic areas (TAs). Leads in a team environment and matrix. Able to function independently as a lead writer on any compound. May consult with more senior colleagues on complex situations. Leads discussions in or leads process working groups. May lead and actively participate in setting functional tactics/strategy. Initiates or provides input into TA-level strategy (eg, submission team, global program team, clinical team). Able to oversee the work of external contractors.
Principal Responsibilities: Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy. Leads or sets objectives for others on team projects and tasks, eg, leading process working groups or Communities of Practice. Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers. Able to function as a lead writer on any compound (or submissions, indications, or disease areas): is primary point of contact for medical writing activities for the cross-functional team (eg, clinical), with support as needed from more senior colleagues on complex situations with cross-functional teams. Leads cross-functional (eg, with clinical team) document planning and review meetings. Interacts with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed. Proactively provides recommendations for departmental process improvements. Completes all time reporting, training, and metrics database updates as required in relevant company systems. Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed. May interact with senior cross-functional colleagues to strengthen coordination between departments. May represent medical writing in industry standards working groups.
Principal Relationships: Internal relationships include the Medical Writing leadership team, manager, other writers, cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in preparation and planning of clinical documents, and employees from other departments such as Human Resources, Finance, Information Technologies, Procurement, and Partnerships. External relationships may include overseeing day-to-day project-related work of contractors or external service providers as needed and collaborating with external partner company staff on codeveloped compounds. Supervision includes direct reports (if applicable), and others as assigned.
Other: Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently. Resolves majority of problems independently. May consult with senior colleagues on higher complexity situations. May interact with senior cross-functional colleagues often requiring coordination across multiple functions and groups to resolve issues. Excellent oral and written communication skills. Attention to detail. Ability to lead in a team environment. Expert time management for self, direct reports (if applicable), and teams. Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Demonstrates learning agility. Builds and maintains solid and productive relationships with cross-functional team members. Solid knowledge and application of regulatory guidance documents such as ICH requirements.
EN: BusinessJP: Not Required
Marriott International
