[Innovative Medicine] Senior Manager/Associate Director, Medical Writing, Integrated Data Analytics

At 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 https://www.jnj.com

Job Function:
Medical Affairs Group

Job Sub Function:
Medical Writing

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

 Position Summary:


* Able to function as a lead writer on any compound independently.


* Leads in setting functional tactics/strategy.


* Leads project-level strategy (eg, submission team, global program team, clinical team).


* May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority.


* Able to write and coordinate complex documents within and across TAs independently.


* Contributes to and champions internal standards, regulatory, and publishing guidelines.


* Contributes to and champions the improvement of internal systems, tools, and processes.


* Able to lead process working groups.


* Able to oversee the work of external contractors.


* May have additional major responsibility with supervision:


* Cross-functional, cross-TA, or cross-J&J initiative/collaboration.


* Larger organizational responsibility (eg, manage a subset of TA).


* If a people manager:


* Manages a team of internal medical writers (direct reports).


* Accountable for the quality of deliverables and compliance of direct reports.


* Actively participates in resource management and hiring decisions.

Principal Responsibilities:


* Able to lead compound/submission/indication/disease area writing teams independently.


* Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.


* Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.


* Establishes and drives document timelines and strategies independently.


* Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.


* Proactively identifies and champions departmental process improvements.


* May develop and present best practices or innovations to internal or external audiences.


* May lead cross-functional, cross-TA, or cross-J&J process improvement initiatives.


* Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Program Team meetings...