Regulatory Medical Writing Manager

1 settimana fa

Roma, Lazio, Italia Johnson & Johnson A tempo pieno

Job Title: Medical Writing Manager - Oncology Regulatory

Job Summary:

Johnson & Johnson Innovative Medicine is seeking a Medical Writing Manager - Oncology Regulatory to support our Oncology team. The successful candidate will be responsible for preparing and finalizing clinical documents, leading a team environment, and providing recommendations for departmental process improvements.

Key Responsibilities:

  • Prepare and finalize all types of clinical documents.
  • Lead 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.
  • Lead or set objectives for others on team projects and tasks, including leading 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.
  • Act as the primary point of contact and champion for medical writing activities for the clinical team.
  • Maintain knowledge of industry, company, and regulatory guidelines.

Qualifications:

  • University/college degree required, with a Master's or PhD preferred.
  • At least 8 years of relevant pharmaceutical/scientific experience, with at least 6 years of relevant medical writing experience required.
  • If a people manager, preferably up to 2 years of people management experience.
  • Oncology therapeutic area experience preferred.

About Johnson & Johnson:

Johnson & Johnson is a leading healthcare company that discovers and develops innovative medical solutions to address important unmet medical needs. We are committed to helping people live full and healthy lives.

Equal Opportunity Employer:

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.

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