Biotech and Agricultural Creative and Design Management & Business Others Medical and Healthcare
1 - 2 Years
Medical Writing Manager
Leads in a team environment and matrix
Applies internal standards, regulatory, and publishing guidelines
Masters the use of internal systems, tools, and processes
Able to prepare basic and complex documents (within the therapeutic area [TA]) (see examples under "principal responsibilities") independently and across TAs under general supervision.
Able to function as a lead writer on any compound with general supervision.
Leads discussions in or leads process working groups
Actively participates in setting functional tactics/strategy
Provides input into TA-level strategy (eg, submission team, global program team, clinical team)
Able to oversee the work of external contractors.
If a people manager:
o Manage a team of internal medical writers (direct reports)
o Accountable for compliance aspects of direct reports' work
Prepares and finalizes all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
Leads cross-functional document planning and review meetings.
Leads in a team environment. Works with a high-level of independence and takes a lead role on assigned projects with respect to timing, scheduling, and tracking.
Directly leads or sets objectives for others on team projects and tasks, eg, able to lead process working groups or Communities of Practice.
Guide or train cross-functional team members on processes, best practices; coach or mentor more junior writers.
Able to lead compound/submission/indication/DAS writing teams with general supervision.
Proactively provides recommendations for departmental process improvements.
If a Lead Writer, principal responsibilities include, but are not limited to:
o Primary point of contact for Clinical/Global Program Team for medical writing activities.
o Responsible for functional planning and metrics database updates for assigned program.
o Responsible for championing RegMW best practices on assigned program.
o Responsible for setting strategy and leading writing group on health authority submissions.
Experince and Education:
A university/college degree is required plus at least 8 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, PhD, MD) is preferred.
At least 6 years of relevant medical writing experience is required.
Decision Making and Problem Solving:
Recognizes how to best interpret, summarize and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance from functional management.
Resolves complex problems under general supervision.
Qualities and Characteristics:
Excellent oral and written communication skills
Attention to detail
Ability to lead in a team environment
Expert time management for self and teams
Demonstrates learning agility
Builds and maintains solid and productive relationships with cross-functional team members.
Solid knowledge and application of regulatory guidance documents such as ICH requirements
Belgium-Antwerp-Beerse- Other Locations
Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-United Kingdom, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House Organization
Janssen Pharmaceutica N.V. (7555) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies