Manager Immunology Regulatory Medical Writing

Salary Not Specified

J&J Family of Companies, Terriers, Wycombe

Full time
Permanent
Remote working

Posted today, 6 Nov | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

job Ref: feef86a23ab64c8c9018db2fb65dfb40

J&J Family of Companies

Full Job Description

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 goalsetting, and performance discussions.

University/college degree required. Masters or PhD preferred., 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 crossfunctional team members.
Solid knowledge and application of regulatory guidance documents such as ICH requirements.

J&J Family of Companies Manager Immunology Regulatory Medical Writing in England, United Kingdom, 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.