- Work independently on client projects while collaborating with cross-functional teams and communicating with directors.
- Develop and train a team of medical writers, providing guidance and support.
- Engage in matrix management across diverse teams as required.
- Lead the development of regulatory documents, including clinical study protocols, clinical study reports, investigator's brochures, regulatory submissions and responses to inquiries.
- Oversee preparation of scientific publications, for journals and conferences.
- Collaborate with internal cross-functional teams ensuring alignment across regulatory documents and publications.
- Act as the primary client contact regarding medical writing projects, providing project updates and addressing concerns.
- Ensure compliance with regulatory requirements and internal quality processes.
- Stay updated on industry trends and implement process improvements and training.
- Support business development efforts though proposal development, client presentations, and other activities aimed at expanding medical writing services.
About you
Medical Writing Manager are pivotal to oversee a team of medical writers, maintain writing schedules and continuously seek ways to improve work quality. Qualified candidates must meet a set of criteria we deem essential:- Advanced degree in Life Sciences, Pharmacy, or a related field required (e.g., MSc, PhD) preferred.
- Minimum of 10 years of medical writing experience in pharmaceutical or biotechnology industries, including regulatory and/or publication writing.
- Strong knowledge of regulatory requirements (e.g., ICH, FDA, EMA) for clinical and regulatory documents.
- Excellent written and verbal communication skills with the ability to effectively convey complex scientific and medical information to diverse audiences.
- Strong leadership and team development skills.
- Detail-oriented with strong organisational and project management skills, with the ability to prioritise tasks and meet deadlines in a fast-paced environment.
- Proficient in Microsoft Office Suite and document management systems.
- Experience in line management and delivering internal and external training.
- Ability to manage multiple projects in a matrix environment.
Our commitment to you
A career at RApport-ELIQUENT is an opportunity to hone your skills and develop in the direction you choose. Join us and you'll experience a purpose you can believe in and an impact you can see.
We're committed to building a culture that empowers all of our people to thrive and feel a sense of belonging at RApport-ELIQUENT. We invest in outstanding people, building a team of future thinkers from diverse backgrounds, empowering them to achieve their potential.
What makes RApport-ELIQUENT a great place to work?
We will empower you to choose the working pattern that works best for you and how you work best, to be collaborative, learn from the team, share your experience and insight, build relationships that drive your career and prioritise your wellbeing. We offer an environment where you can experience a purpose you believe in, the freedom to bring your true self to work every day, growing and developing at a pace that's right for you.
We believe it's only when you're comfortable and at your best that you can make the greatest impact on those around you.
- Advanced degree in Life Sciences, Pharmacy, or a related field required (e.g., MSc, PhD) preferred.
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Medical Writing Manager - Surrey, United Kingdom - RApport Global Strategic Services Ltd
3 weeks ago
Description
Find your place and use your experience to make an impact.
We are RApport-ELIQUENT A specialist international regulatory consultancy, bringing cutting-edge and life-changing medicines and medical devices to global markets.
The RApport-ELIQUENT team continues to grow from strength to strength, with the team applying our latest thinking in creating the next generation of regulatory solutions that deliver value to some of the largest organisations in our industry. We help our clients to solve their regulatory challenges by developing bespoke solutions that meet their unique needs.
Our team operates at a global level. There is plenty to learn, space to develop and make a real contribution with an opportunity to participate in a wide range of engagements.
The Opportunity
Medical Writing Manager
We are seeking a talented and experienced Medical Writing Manager to join our expanding team. The role of the Medical Writing Manager involves creating top-tier regulatory documents and scientific publications across diverse therapeutic fields. You'll support and lead Medical Writing initiatives for the senior management and operational teams of our clients, in the UK, Europe, and internationally.
What you'll do
As a Medical Writing Manager, you will represent RApport-ELIQUENT at client meetings and work collaboratively with internal and external stakeholders offering visibility and opportunity to directly contribute to the companies' success. Key responsibilities you can expect to accomplish include: