ICON Strategic Solutions Hiring for Senior Medical Writer at Dover, Delaware Full Time

As a Sr. Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

Main job tasks:

Perform medical writing tasks:

• Clinical trial reports (CTRs)

• Lay summaries of clinical trial results

• Clinical evaluation plans (CEP) and Clinical evaluation reports (CER)

• Investigator brochures (IBs)

• Paediatric investigational plans (PIPs)

• Clinical summary and overview documents in CTD/eCTD format for regulatory submissions world-wide (including investigational medicinal product dossiers (IMPDs), investigational new drug applications (INDs), marketing authorisation applications (MAAs), new drug applications (NDAs), variations and supplemental new drug applications (sNDAs))

• Replies to questions from authorities

• Deliverables (briefing book, slides) for Advisory Committee Meetings

• Publications (abstracts, posters and slide presentations for conferences and other scientific meetings, and manuscripts for scientific journals)

• Protocol, protocol outlines and SI/IC

• Other ad-hoc documents (e.g. meeting packages)

Specialist in medical writing within therapeutic area:

• Maintain knowledge and competencies within relevant therapeutic and professional areas

• Drive the sharing of better practices across projects/indications within the therapeutic area

• Be updated on relevant guidelines and other external requirements in the therapeutic area

• Represent medical writing in relevant fora based on experience and knowledge in the therapeutic area

• Provide therapeutic area-specific support and training to other medical writers

• Establishing new and improved methods within field of expertise

Set direction and drive discussion, ensure decisions are taken and influence and implement project strategy:

• Assume role as Project Medical Writer (PMW) and/or Clinical Submission Team Lead (CST)

• Act as primary stakeholder contact concerning project-specific medical writing issues

• Reach out to relevant key stakeholders to identify the need, timing and scoping of MW documents

• Represent MW in relevant project groups (e.g. Clinical Development Team, M&S team, Clinical Submission Team, Publication Planning Group)

• Review project-related documents and trial-specific documents before trial MW is assigned

• Develop project specific writing guidance to ensure aligning across MW documents with regards to the level of details and structure of result presentation

• Inform managers about resource issues (e.g. right qualifications, mandate, allocation) in due time

• Prioritise and delegate tasks within the project

Contribute to knowledge sharing, skill building and good collaboration with stakeholders and colleagues:

• Act as mentor and trainer for other medical writers on all levels

• Ensure that project team members know their role and create motivation within the team

• Represent CLinical Reporting in on-going improvements in cross-functional and global collaborations and sharing of better practices and knowledge

• Support execution of Clinical Reporting strategy and vision in line with the leadership team

• Ensure that the strategy within own area is built into the project strategy from an early stage

• Maintain good working relationships with stakeholders and colleagues

Add other main job functions, if relevant:

• Add, as relevant.

You are:

• ≥5 years experience as Medical Writer or equivalent

• Pharmaceutical industry understanding

• Excellent understanding of clinical development and regulatory processes and requirements

• Business and R&D value chain understanding

• Excellent communication and presentation skills

• Experience with a broad range of different medical writing tasks

• Good mentoring and training skills

• Demonstrated ability to identify better practice and create improvements in methods, techniques, approaches etc

• Established record of being a proactive team-player and able to deliver on time and with high quality.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career – both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.