Manager, X-TA Regulatory Medical Writing Job at Johnson & Johnson Innovative Med

Overview

Join to apply for the Manager, X-TA Regulatory Medical Writing role at Johnson & Johnson Innovative Medicine .

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 Details

Job Function : Medical Affairs Group

Job Sub Function : Medical Writing

Job Category : People Leader

Locations

The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). Locations listed are examples and do not limit applications. Candidates from any location may apply.

Hybrid : 3 days onsite weekly. Remote options may be considered on a case-by-case basis.

You Will Be Responsible For

• Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
• Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
• Lead and actively participate in setting functional tactics / strategy as needed.
• Oversee the work of external contractors
• Leading or setting objectives for others on team projects and tasks, e.g., leading process working groups.
• Guiding or training cross-functional team members on processes and best practices.
• Potentially leading project-level / submission / indication writing teams.
• If a lead writer for a program / compound (or submissions, indications, or disease areas) : act as the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participating in medical writing and cross-functional meetings.
• Proactively provide recommendations for departmental process improvements.
• Maintaining knowledge of industry, company, and regulatory guidelines.
• Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
• Interacting with senior cross-functional colleagues to strengthen coordination between departments.
• Representing Medical Writing department in industry standards working groups if and as needed.
• Complete all time reporting, training, and metrics database updates as required in relevant company systems.
• If a people manager :
• Manage a team of internal medical writers (direct reports).
• Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
• Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Ensures direct report’s adherence to established policies, procedural documents, and templates.
• Accountable for the quality of deliverables and for compliance of direct reports.
• Participate in resource management and hiring decisions.

Education And Experience Requirements

Other Requirements

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