Medical Writer III

Medical Writer III

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Medical Writer III within our Regulatory Medical Writing team, part of Integrated Data Analytics & Reporting (IDAR), to support our Immunology therapeutic area. This position may be located in Spring House / Raritan/Titusville/Horsham, United States or, High Wycombe, United Kingdom; Leiden, The Netherlands; Beerse, Belgium; Allschwil, Switzerland. This is a hybrid position (3 days per week onsite, 2 days work from home). Remote work options may be considered on a case-by-case basis and if approved by the company.

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:

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional (eg, with clinical team) document planning and review meetings. Interacting 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.
• Completing 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).
• Coaching or mentoring more junior staff on document planning, processes, and content. Provides peer review as needed.
• Actively participating in or leads process working groups.

Principal Relationships:

• Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents.
• External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

Education and Experience 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 industry experience including at least 4 years of regulatory medical writing experience!
• Immunology therapeutic area experience is strongly preferred.
• 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 under general supervision.
• Compound lead and/or submission lead experience is preferred.
• Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine.
• Able to build solid and positive relationships with cross-functional team members.
• 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.
• Able to resolve complex problems under supervision.
• Demonstrate learning agility (self-development) and mentoring competency (development of others).
• Strong attention to detail.
• Builds solid and productive relationships with cross-functional team members.

For United States Applicants:

The anticipated base pay range for this position is $109,000 to $174,800.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to:

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Required Skills:

Cross-Functional Partnerships, Lead Work, Medical Writing, Regulatory Writing

Preferred Skills:

Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Problem Solving, Process Oriented, Proofreading, Quality Standards, Research Ethics, Standard Operating Procedure (SOP)