Document Specialist

Document Specialist

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

The Sr MW is responsible for the generation of consistently high-quality clinical documentation content and capable of working across multiple accounts and projects seamlessly. The incumbent is a contributing scientific expert in their allocated therapy areas and can accurately incorporate strategic concepts into projects whilst guiding others. In addition to this, the incumbent is responsible for preparing regulatory documents for submission to regulatory authorities. Working with minimal guidance, the incumbent will take accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. Applying project management expertise and contributing to functional excellence through process management, the incumbent will also play a role in guiding other medical writers.

Main Responsibilities / Job Expectations

Main Medical Writing Responsibilities

• Lead Writing/Editing Complex Clinical Dossiers
• Manage the Preparation/Preparation of a Complex Suite of Regulatory Documents E.g. Protocols, CSRs, Briefing Documents, Meeting Requests, Investigator Brochures, Clinical Modules
• Review Documents to Ensure Compliance with Documentation Quality Standards, Regulatory Requirements and Consistency of Messages Across All Documents for a Product Within a Clinical Dossier
• Plan and Create Timelines to Produce Assigned Documents
• Ensure Proper Planning and Resourcing of All Documents Assigned to Writing/Editing Team
• Actively Contributes to Best Practices and Continuous Improvement Within the Therapeutic Area
• Represent the Group in Functional and Cross Functional Initiatives/Projects When Required
• Network and Share Best Practices to Ensure Efficiency and Consistency Across Product Teams

Project Delivery

• Able to Work Across Multiple Projects and Accounts Simultaneously
• Demonstrate a Thorough Understanding of Timelines, Budgetary Constraints and Scopes of Work
• Adhere to the Quality Control Process and Ensure All Work Produced Has Gone Through the Correct Internal Review Process
• Demonstrate a Good Understanding of Project Management and Resource Planning
• Maintain a Working Knowledge of Pharmaceutical Industry Standards and Compliance
• Stay Informed of Upcoming Projects, Assist Management in Projecting Resources, and Perform Administrative Duties as Requested
• Oversee Medical Writing Consultants and Vendors and Their Writing Activities to Ensure Timely and Quality Deliverables Are Completed Within Budget

Communication

• Understand the Purpose and Role of Communications in the Wider Therapy Area and Commercial Landscape
• Demonstrate the Ability to Communicate Clearly to Different Audiences Through a Variety of Media (Print and Digital)
• Identify and Communicate Important Therapy Area Updates and Any Medical/Regulatory Milestones to the Team and Clients Where Appropriate. Link This with Any Potential New Business Opportunities Where Applicable
• Provide Regular Feedback to Senior Teams Across Accounts and Projects
• Mentor Less Experienced Medical Writers

EHS Responsibilities:

• Comply with Applicable EHS Regulations and Procedures.
• Participate in the Site's EHS Performance by Reporting Risks, Malfunctions or Improvements
• Participate in Mandatory EHS Training

Knowledge, Abilities & Experience

Education / Certifications:

• Life Sciences Degree, Preferably MSc or PhD, or Equivalent Combination of Education and Experience

Experience:

• Minimum 5 Years Medical Writing Experience in a Pharmaceutical Company or Equivalent Combination of Education and Experience
• Working Knowledge of ICH and US Regulatory Requirements Is Required; Working Knowledge of Other Ex-US Regulatory Requirements Is Desired
• Working Knowledge of Drug Development, Clinical Research, Study Design, Biostatistics, Pharmacokinetics, the Regulatory Environment, and Medical Terminology
• Recognised Industry Qualification in Medical Writing (Such as the Professional Development Qualifications Provided by the American and European Medical Writing Associations) Would Be Advantageous
• Proficient in Using Microsoft Office Programmes (E.g. PowerPoint, Excel, Etc.)
• Have an Excellent Command of the English Language in Both Written and Verbal Communications Desirable
• Previous Experience in a Medical Communications Agency or Industry Would Be Advantageous
• A Keen Interest in Working and Developing Scientific Expertise Across a Range of Therapy Areas
• Flexible Approach to Working, with the Ability to Reprioritise and Work Under Pressure When Needed
• Excellent Time Management Skills and Demonstrated Ability to Forecast and Manage Workload

Languages:

• English (Excellent Level Both Written and Verbal)

Key Technical Competencies Required

• Experience as a Clinical/Regulatory/Safety Medical Writer, I.E., Preparation of a Wide Range of Clinical/Regulatory Documents Including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Reports, and Manuscripts.
• Able to Manage Coordination Responsibilities Beyond Writing Individual Documents, E.g., Timelines, Reviews and Submissions

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is from $91,500-$134,200.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills