Director Medical Writer at ProQR Therapeutics
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Regulatory Affairs department is currently looking for a Director Medical Writer (Full-time) to join our team. You will be reporting to the VP Global Regulatory Affairs.
Location: Leiden, NL or remotely based.
The purpose of the job of the Director Medical Writer is to oversee, prepare, write, and review scientific and regulatory documentation needed in support of research and development activities, including clinical trials and corresponding submissions to regulatory authorities and other writing and publication activities within the company. The Medical Writer contributes to strategy development for document authoring, contributes strategically and scientifically at the project and/or study team level, ensuring high-quality, scientifically accurate documents, ensures consistency between related documents, and improves overall document quality. To accomplish this, the Medical Writer liaises with different internal and external teams to execute the document development.
Key duties and responsibilities:
• Coordinate and oversee all medical writing activities Develop medical writing processes, standards, and improvement initiatives
• Write regulatory documents including, but not limited to, Investigator’s Brochures, Protocols, Clinical Study Reports, Nonclinical and Clinical Summary Documents, Briefing Documents and scientific publications (eg, manuscripts, abstracts, slides)
• Oversee and coordinate external writers and vendors/agencies
• Provide appropriate background information, guidance, and training to any writer producing documents to support their tasks
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents, ensure consistency between related documents, and improve overall document quality
• Assist in/coordinate medical writer activities on multiple programs; attend team meetings and contribute to program goals, key messages, and timeline discussions
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
• Review documents, including those authored by others both internally and externally
• Ensure clinical documents adhere to standards and regulatory guidelines
• Ensure that project/department milestones/goals are met adhering to approved budgets
We expect our Director Medical Writer to have:
• a minimum of an undergraduate degree in a scientific discipline (B.A., B.Sc.), but a graduate degree (M.Sc., Ph.D., Pharm.D.) is preferable
• a minimum of 5-7 years of relevant industry experience as a medical writer
• experience in authoring NDA/MAA modules highly desired
• excellent writing and communication skills
• excellent attention to detail, consistency, grammar, syntax, and scientific accuracy
• the ability to work in team structure, as well as independently
• the ability to comply with company and/or industry style guides and templates
• strong project management and organizational skills
• understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
• technical expertise in Microsoft Word, Adobe Acrobat
• ability to prioritize multiple tasks and work within condensed timelines.
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with the following benefits:
• 8% holiday allowance
• 30 vacation days
• An annual performance bonus
• Stock options
• A premium-free pension plan
• A commuting allowance
• A subsidized staff restaurant
• Flexible working arrangements
• Unlimited (un)healthy snacks and drinks
• Employee events (boot camp, chair massage and other social events)
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact Femke Hekelaar via email@example.com if you have any questions.