Manager, Oncology Regulatory Medical Writing

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Key Responsibilities:

• Prepare and finalize all types of clinical documents.

• Lead in a team environment. Work with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.

• Lead or set objectives for others on team projects and tasks, eg, lead process working groups.

• Guide or train cross-functional team members on processes and best practices.

• May lead project-level/submission/indication writing teams.

• Proactively provide recommendations for departmental process improvements.

• 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.

• Actively participate in medical writing and cross-functional meetings.

• Maintain knowledge of industry, company, and regulatory guidelines.

• Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.

• May interact with senior cross-functional colleagues to strengthen coordination between departments.

• May represent Medical Writing department 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 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!

• If a people manager, preferably up to 2 years of people management experience.

• Oncology therapeutic area experience preferred.

• Attention to detail.

• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.

• Expert project/time management skills.

• Strong project/process leadership skills.

• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.

• Able to resolve complex problems independently.

• Demonstrate learning agility.

• Able to build and maintain solid and positive relationships with cross-functional team members.

• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

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.