Job Function:
Professional
Job Description: Purpose:
- Able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs.
- Leads in a team environment and matrix.
- Able to function as a lead MW on most compounds, under supervision.
- Actively participates in or leads process working groups.
- Provides input into functional tactics/strategy (eg, writing teams, process working groups).
- Highly proficient in the use of internal systems, tools, and processes.
You will be responsible for:
- Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
- 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.
- Completes all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
- Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision. Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
- Coaches or mentors more junior staff on document planning, processes, and content. Provides peer review as needed.
- Actively participates in or leads process working groups.
Qualifications / Requirements:
- A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
- At least 6 years of relevant pharmaceutical/scientific experience is required.
- At least 4 years of relevant clinical/regulatory medical writing experience is required.
- Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.
- Excellent oral and written communication skills.
- Attention to detail.
- Ability to function in a team environment.
- Organizes time well.
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
- Demonstrates learning agility.
- Builds solid and productive relationships with cross-functional team members.
eQuest
