Senior Medical Writer

• Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules
• Lead Writing/Editing complex Clinical Dossiers/Safety Reports
• 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 contribute 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

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 5+ years of experience in clinical and regulatory medical writing within pharmaceutical, biotechnology, academic, or CRO settings.
• 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
• Proficient in using Microsoft Office programmes (e.g. PowerPoint, Excel, etc.).
• 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.
• 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.

Knowledge & Experience (preferred):

• Previous experience in a medical communications agency or industry is a plus.

Education / Certifications (essential):

• Life sciences degree, preferably MSc or PhD, or equivalent combination of education and experience.
• Recognized industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations).

Language(s):

• Fluent in English.
• French is a plus.

psen 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 $112,500-$165,000.

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.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.