Manager Regulatory Medical Writing

vor 15 Stunden

Bern, Schweiz Johnson & Johnson Family of Companies Vollzeit

Janssen Pharmaceutica NV, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Manager Regulatory Medical Writing** to support the Infectious Diseases and Vaccines therapeutic area.

This position can be located in Belgium (Beerse), the Netherlands (Leiden), the U.K. (High Wycombe), Switzerland (Bern), Germany (Neuss), or the U.S. (Titusville, NJ, Raritan, NJ, Spring House, PA)

**Key Responsibilities**:

- Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. Take a lead role with respect to content and scientific strategy.
- Lead cross-functional document planning and review meetings. Interact with peer writers and colleagues from other departments. Able to lead program-level or submission writing teams with general supervision. Able to lead process working groups.
- Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed. You may lead the work of other medical writers, external contractors, and document specialists supporting a project.
- Work with a high level of independence, responsible for establishing document timelines and strategies in accordance with internal processes, with mínimal guidance.
- If a lead writer for a program:

- Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning, setting strategy, and leading writing group for assigned program.
- Champion medical writing standard processes and provide recommendations for departmental process improvements.
- Maintain and disseminate knowledge of the industry, company, and regulatory guidelines. May 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 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience.
- If a people manager, preferably up to 2 years of people management experience.
- Strong oral and written communication skills.
- 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.
- Attention to detail.
- Able to resolve complex problems under general supervision.
- Demonstrate learning agility.
- Able to build and maintain solid and positive relationships with cross‐functional team members.
- Strong leadership skills, both in time management as well as in project/process management.

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.

**Ready to be part of something great? Don't forget to apply. We want YOU**

**Primary Location**
Belgium-Antwerp-Beerse
- **Other Locations**
North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Berne-Bern, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss
**Organization**
Janssen Pharmaceutica N.V. (7555)
**Job Function**
R&D
**Requisition ID**
2206018000W

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