Associate Director, X-TA Regulatory Medical Writing

Job Title

Associate Director, X-TA Regulatory Medical Writing

Function

Medical Affairs Group

Sub Function

Medical Writing

Category

People Leader

Location

Beerse, Antwerp, Belgium; Leiden, South Holland, Netherlands; High Wycombe, United Kingdom; Spring House, PA, Raritan, NJ, Titusville, NJ, United States

Job Description

We are searching for a Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more therapeutic areas within the X-TA Regulatory Medical Writing area. This position can be located in a hybrid role (3 days in office and 2 remote). Remote work options may be considered on a case-by-case basis and if approved by the Company.

Responsibilities

• Leading compound/submission/indication/disease area writing teams independently.
• May have additional major responsibility with supervision.
• Cross-functional, cross-TA, or cross-J&J initiative/collaboration.
• Larger organizational responsibility (e.g., manage a subset of TA).
• Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking.
• Leading program-level/submission writing teams independently.
• Directly leading or setting objectives for others on team projects and tasks.
• Guiding or training cross‑functional team members on processes, best practices; coach or mentor more junior writers.
• Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
• Leading cross‑functional/cross‑TA, cross‑J&J process improvement initiatives, or other large process working groups.
• Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
• If a lead writer for a program:
  • 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.
  • Able to function as a lead writer on any compound independently.
  • Leading discussions in Medical Writing and cross‑functional meetings as appropriate.
  • Interacting with senior cross‑functional colleagues and external partners to strengthen coordination between departments.
  • Able to oversee the work of external contractors.
• As a people manager:
  • Manage direct reports in Medical Writing.
  • Set objectives for individual team members. Regularly meets 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.
  • Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal setting and performance discussions.

Qualifications / Requirements

• University/college degree in a scientific discipline is required. Masters or PhD preferred.
• At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is required.
• At least 2 years of people management experience.
• Multiple therapeutic area experience preferred.
• Strong attention to detail.
• Strong oral and written communication skills. Fluent written and spoken English.
• Expert project management skills, expert project/process improvement leadership.
• Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills.
• Ability to delegate responsibility to junior writers.
• Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.

Required Skills

Medical Writing, People Management, Project Management, Regulatory Writing, Solid Scientific Background

Preferred Skills

Analytics Insights, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross‑Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Succession Planning, Tactical Planning, Team Management

Benefits

Employees and/or eligible dependents may be eligible to participate in company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

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