Associate Director, Regulatory Medical Writing

This position will lead medical writing (MW) activities in the gastrointestinal disease area, and will lead a team of internal writers who can be deployed across J&J Immunology programs. This role will report directly to the Regulatory Medical Writing Delivery Unit Head, Immunology.

• Is the primary point of contact for MW activities for the cross-functional team in the disease area.
• Writes or coordinates all types of clinical and regulatory documents, taking a proactive lead role in driving 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-therapeutic area, or cross-J&J process improvement initiatives.
• Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, study team meetings, clinical team meetings).
• Maintains and disseminates knowledge of industry, company, and regulatory guidelines.
• Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.
As a people manager:
• Leads and is accountable for direct reports.
• Ensures team members adhere to established policies, procedural documents, and templates.
• Participates in hiring, onboarding, conducting career and talent development discussions, goal-setting, performance reviews, and compensation planning.
  
  University/college degree required. Masters or PhD preferred., At least 10 years of relevant pharmaceutical/scientific experience, including at least 8 years of relevant regulatory medical writing experience, is required
• At least 2 years of people management experience is required
• Excellent oral and written communication skills.
• Experience in project management and process improvement is required. Expert time management for self, direct reports, and teams
• Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
• Strong people management skills
• Ability to serve as the liaison between team members and senior leadership within the immunology therapeutic area is required.
• Ability to build and maintain solid and productive relationships with cross-functional team members is required.
  
  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
  
  The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
• Employees and/or eligible dependents may be eligible to participate in the following 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 of Work, Personal and Family Time - up to 40 hours per calendar year