Pharma IT is hiring experienced Senior/Principal Medical Writer Consultants to join our Regulatory Affairs & Medical Writing Team!
In this role, you will work as a consultant to support our clients in the Pharma, Biotech and Medical Device industries.
In this position, you will work on-site at the client’s location or remote with the support of the rest of the Regulatory Affairs & Medical Writing team as well as other experts within Pharma IT and PLG, when you need it.
The ideal candidate will have experience from different biotech and pharma companies working with clinical development in different indications.
As a Medical Writer Consultant, you will:
- Write and review clinical (and nonclinical) documents for regulatory submissions in the EU and US, such as Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety, clinical trial protocols and reports, Paediatric Investigational plans, Orphan Drug Designation applications, Investigator’s Brochure, meeting requests and briefing documents, and other related documents as requested by our clients.
- Participate in answering questions from Health Authorities world-wide
- Write and review scientific publications and scientific presentations
- Collaborate with cross-functional teams, including external stakeholders, to ensure project goals, deliverables, and requirements.
- Foster effective communication and collaboration among project team members, ensuring clarity of roles and responsibilities.
- Ensure compliance with regulatory requirements and industry standards throughout the project lifecycle.
- Evaluate project outcomes and provide recommendations for process improvements and best practices.
The ideal candidate for this position holds the following qualifications:
- A graduate degree (PhD, MSc., M Pharm, Pharm D, or equivalent).
- 10+ years of experience within drug development in the pharma/biotech industry with at least 5 years experience with medical writing
- Understanding of international regulations, ICH guidelines etc. related to document preparation and production (CTDs).
- Understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
- Excellent interpersonal skills, with the ability to collaborate effectively with multidisciplinary teams.
- Exceptional problem-solving and decision-making abilities, with a focus on achieving results.
- Excellent written and verbal communication skills in English, with the ability to present complex information to diverse audiences.
About Our Firm
Pharma IT aims to deliver price-competitive young talent and experienced professional consultants to the pharma, biotech, and medical device industries. Our exclusive focus on these industries and agile, customer-oriented approach ensures we maximize customer value.
We assist clients across all key areas of these industries, including: Management & Business Consulting, IT Consulting, Drug Development, Medical Device Consulting, Manufacturing Consulting, Quality, Compliance & Security Consulting.
Our team consists of ~140 diverse and talented consultants, and we are currently experiencing rapid growth. We encourage people of all ages, genders, sexual orientations, nationalities, religions, and ethnic backgrounds, to apply.
If you want to know more about us, feel free to check out our website at pharmait.dk/about
You can learn more about Pharma IT’s Medical Writing services and team, here: Scientific & Medical Writing Consulting - Pharma IT
Pharma IT is part of the global life science consulting conglomerate, ProductLife Group (PLG). You can learn more about PLG, here: https://www.productlifegroup.com/
Benefits
Pharma IT offers industry-leading contracts and work-life balance. We offer a base salary with an accelerated bonus model as part of what we believe is one of the best employment packages in the industry. Our core belief is that employees should have flexible hours, do what they are best at, and be able to spend as much time at our customers’ sites as possible by limiting internal bureacracy.
How to Apply
This position will be filled on a rolling basis. Interested applicants should apply via LinkedIn. If you have any questions about this role, feel free to reach out to the hiring manager for this position, Anne Louise Kirkegaard at alki@pharmait.dk
