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Ferring Pharmaceuticals

Senior Medical Writer

Fuldtid

Permanent

København, Tårnby

SE PÅ KORT
ID: 2584035
|
Indrykket for 40 dage siden

Job Description:

Are you looking for new opportunities to develop in your career as a medical writer? Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

We are currently looking for a Senior Medical Writer to join us as we develop innovative solutions that help people live better lives.

In the Global Medical Writing department at Ferring Pharmaceuticals, we provide comprehensive and submission-ready documents for all stages of the clinical development process and across all our therapeutic areas. We collaborate closely with clinical development and clinical trial team members to provide high-quality regulatory documents compliant with Ferring standards, ICH guidelines and national regulatory requirements, supporting end-to-end clinical development.

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

Join a social team with high-level expertise and strong integrity

You will join a fantastic team of highly educated medical writers with advanced expertise and strong integrity. Your new colleagues are supportive, fun, and ready for new challenges. They value collaboration, scientific discussions, and they are always ready to lend a helping hand. As we support global clinical development activities across all therapeutic areas within Ferring, you will work with stakeholders across the organisation within medical and science, global clinical operations, global regulatory affairs, global biometrics, global safety, global market access and more – being their partner for medical writing.

You will be a core member of clinical development and trial teams, utilizing your unique your skill set, understanding of the end-to-end value chain from planning to registration, your scientific communication skills, project management skills and collaborative mindset daily.

Deliver high-quality clinical documents for end-to-end clinical development 

Reporting to our senior director, Global Medical Writing, you will be responsible for driving and developing clinical documents regarding the planning, reporting and communication of clinical trials conducted globally by Ferring. You can look forward to writing a variety of regulatory documents, this includes (but is not limited to) outlines, protocols, amendments, IB, CTR, clinical documents for regulatory dossiers, and other ad-hoc clinical documents to support health agency interactions.

Your main responsibilities will be to:

  • Plan, coordinate and author the documents required for end-to-end clinical development
  • Support document preparation towards health agency interactions
  • Analyze and interpret clinical trial data together with relevant clinical team members
  • Participate in the project clinical development teams and clinical trial teams as a core member, and provide guidance on the regulatory requirements for the documents we deliver and best practice approach to present our data in the documents
  • Contribute to the optimization of our processes and procedures
  • Keep up to date on regulations pertaining to medical writing
  • Contribute to quality control within the team
  • While participating in cross-functional, global teams, your primary workplace will be our state-of-the-art new domicile Soundport, near Copenhagen Airport. You will also have the option of working from home up to 2 days a week.

    Experienced medical writer with stakeholder management skills

    Whether you already have experience as a senior medical writer or are looking for the next step in your medical writing career, we offer you the opportunity to hone your skills and broaden your experience.

    It is essential that you are well-organized, proactive, and flexible, allowing you to work on multiple projects simultaneously while respecting deadlines. As you will be working cross-functionally in a truly global setting, you will need the ability to adapt to changing circumstances and collaborations. Moreover, you have the necessary stakeholder and project management skills to obtain information from your stakeholders. It is important to have an open mindset and approach to the teams you will be working with.

    We imagine that you:

  • Bring 3+ years of experience as a medical writer in, the pharmaceutical or the biotech industry
  • Have previous experience from working in a global setting and have a global mindset
  • Have an academic degree in life science – ideally a Ph.D. or similar
  • Have knowledge of clinical drug development and regulatory requirements
  • Have a track record of driving and setting timelines for your deliverables
  • Have a willingness to share from experience and improve processes in a collaborative manner
  • Are fluent in English – strong verbal and written skills are a given
  • Ferring + you: Why join Ferring?

    At Ferring Pharmaceuticals, we believe in the power of research. Each of us contributes to providing innovative solutions to help people live better lives. We devote significant research and development investment to new therapeutics, life cycle management and next generation healthcare solutions.

    Our philosophy of “people come first” is lived through every part of our business.

    We empower and support each other to achieve excellence together. And we are committed to supporting all employees in their career development and to ensuring all our team members receive the right level of support and progression. One of our initiatives involves a 3-6-month job swap, where you can gain insight into other aspects of the business (an option if suitable, and once you are established in your new role).

    Contact and application

    If our mission and your vision are aligned, please apply with CV and cover letter! Note that we review applications on an ongoing basis and close the process when we find the right match. 

    Location:

    Ferring Denmark

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