Manager, Regulatory Medical Writing - Immunology

rk, Sweden; also Switzerland and Norway; also India. Remote working options may be considered on a case-by-case basis and with the approval of the business.

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

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.

• Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal 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.

• Work with a high level of independence, taking responsibility on assigned projects for timing, scheduling, and tracking.

• Champion medical writing standard processes and provide recommendations for departmental process improvements.

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

• The role has potential to progress to being a people manager. If a people manager you will:

• Manage direct reports in Regulatory 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 regulatory medical writing 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.

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.