Associate Director, Oncology Regulatory Medical Writing

Description:

Associate Director, Oncology Regulatory Medical Writing

At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medial Writing team is recruiting for an Associate Director to support our Oncology therapeutic area. The position may be located in the UK, other European countries, or Canada. Remote work options may be considered on a case-by-case basis and if approved by the company.

Are you ready to join our team? Then please read further!

Key Responsibilities:

• Prepare and finalize all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Work with a high level of independence and take a lead role on with respect to timing, scheduling, and tracking.
• Able to lead program-level/submission writing teams independently.
• Directly lead or set objectives for others on team projects and tasks.
• Guide or train cross‐functional team members on processes, best practices; coach or mentor more junior writers.
• Proactively identify and champion Medical Writing process improvements.
• Able to develop and present best practices to external audiences.
• Able to lead cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other process working group.
• 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.
• Lead discussions in Medical Writing and cross‐functional meetings as appropriate.
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
• Interact with senior cross‐functional colleagues and external partners to strengthen coordination between departments.
• Able to represent Medical Writing in industry standards working groups.
• If a people manager:
• Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• 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:

Qualifications

Education:

University/college Degree Required. Masters Or PhD Preferred.

Experience and Skills:

We would value a colleague with these qualities:

• At least 12 years of relevant pharmaceutical/scientific experience; at least 10 years of relevant medical writing experience is required!
• If a people manager, at least 2 years of people management experience.
• Oncology therapeutic area experience preferred.
• Strong attention to detail.
• Strong oral and written communication skills.
• 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.
  
  

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.