Manager, Regulatory Medical Writing, Oncology

We are searching for the best talent for Manager, Regulatory Medical Writing, Oncology.

Purpose:

• Able to write and coordinate basic and complex documents independently within and across therapeutic areas (TAs).
• Leads in a team environment and matrix.
• Able to function independently as a lead writer on any compound. May consult with more senior colleagues on complex situations.
• Leads discussions in or leads process working groups.
• May lead and actively participate in setting functional tactics/strategy.
• Initiates or 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:
• Manages a team of internal medical writers (direct reports).
• Accountable for the quality of deliverables and for compliance of direct reports.

You will be responsible for:

• Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
• Leads or sets objectives for others on team projects and tasks, eg, leading process working groups or Communities of Practice.
• Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers.
• Able to function as a lead writer on any compound (or submissions, indications, or disease areas): is primary point of contact for medical writing activities for the cross-functional team (eg, clinical), with support as needed from more senior colleagues on complex situations with cross-functional teams.
• Leads cross-functional (eg, with clinical team) document planning and review meetings. Interacts with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Proactively provides recommendations for departmental process improvements.
• Completes all time reporting, training, and metrics database updates as required in relevant company systems.
• Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
• May interact with senior cross-functional colleagues to strengthen coordination between departments.
• May represent medical writing in industry standards working groups.
• If a people manager:
• Supervises/manages and is accountable for direct reports.
• Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development.
• Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Ensures direct report’s adherence to established policies, procedural documents, and templates.
Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

Qualifications/Requirements:

Education: Minimum of a university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

Experience:

• At least 8 years of relevant pharmaceutical/scientific experience is required.
• At least 6 years of relevant clinical/regulatory medical writing experience is required.
• 0-2 years of people management experience if a people manager.
• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
• Resolves majority of problems independently. May consult with senior colleagues on higher complexity situations.
• May interact with senior cross-functional colleagues often requiring coordination across multiple functions and groups to resolve issues.
• Excellent oral and written communication skills.
• Attention to detail.
• Ability to lead in a team environment.
• Expert time management for self, direct reports (if applicable), and teams.
• Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
• 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.
• If a people manager, lead discussions about direct report goal-setting, performance evaluations and ratings, promotions, and salary adjustments, in close interaction with TA head.

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Process Improvements, Proofreading, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility

Fully Remote