Clinical Leadership Role for Medical Writing and Clinical Reporting
3 days ago
Leadership Opportunity in Global Clinical Reporting
You will lead a team of 7 dedicated employees as Director for Clinical Reporting, overseeing the global medical writing and clinical reporting function.
Your Responsibilities Will Include:
- Management of the Clinical Reporting team, ensuring alignment with key stakeholders and optimal resource allocation to projects and tasks.
- Coaching and developing employees towards successful task execution.
- Ensuring employee goal setting, professional development, and training plans are met.
- Coordinating activities with Global Clinical Development, Global Regulatory Affairs, Safety and Pharmacovigilance, Global Medical Affairs, and affiliate companies as appropriate.
- Executing approved Clinical Development Plans and Regulatory Submission Plans according to timelines.
- Ensuring global public disclosure activities for trials in ALK are executed according to requirements.
- Participating in publication planning activities and supporting development of publication plans.
About You
- A relevant educational background (MSc or PhD).
- Broad experience within medical writing (at least 8 years).
- Proven experience in people management, with the ability to inspire, mentor, and develop your team.
- Thorough knowledge and experience with regulatory interactions (e.g. EMA, US FDA, CA HC, CN CDE or JP PMDA).
- Knowledge about clinical disclosure requirements.
- Developed collaboration and stakeholder management skills.
- Fluency in spoken and written English and exceptional communication and writing skills.
- Experienced IT-user skills.
Career Advancement and Benefits
ALK-Abello offers an attractive working environment for individuals looking for both personal and professional development.
Salary Range
We estimate a salary range between $80,000 - $120,000 per year, depending on location and experience.
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeDirector for Clinical ReportingA challenging leadership opportunity awaits a seasoned professional with expertise in medical writing and team management. As Director for Clinical Reporting, you will be responsible for leading a dedicated team of 7 employees and overseeing the global medical writing and clinical reporting function.The role involves taking a...
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full timeLeadership Opportunity in Clinical ReportingThe Director for Clinical Reporting will lead a team of 7 dedicated employees, overseeing the global medical writing and clinical reporting function. This role is part of the Clinical Data Science management team, responsible for ensuring the fulfillment of Global Clinical Reporting commitments and contributing to...
-
Strategic Medical Reporting Director
1 month ago
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeAbout ALK-Abelló A/SALK-Abelló A/S is a leading pharmaceutical company specializing in allergy immunotherapy. We offer a dynamic work environment that fosters personal and professional growth.We are committed to delivering innovative solutions for patients with allergies, and our team is passionate about making a difference in the lives of those...
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeExciting Opportunity in Global Data ScienceWe are seeking a highly experienced and visionary leader to spearhead our Clinical Reporting function as Director for Clinical Reporting within our Global Data Science team.About the Role:As a key member of our Clinical Data Science management team, you will be responsible for leading a dedicated team of 7 employees...
-
Senior Clinical Reporting Lead
1 month ago
Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full timeAbout the RoleThe Senior Clinical Reporting Lead will lead a team of 7 dedicated employees and be responsible for the global medical writing and clinical reporting function. As part of the Clinical Data Science management team, this role will ensure the fulfillment of Global Clinical Reporting commitments and contribute to a positive working environment with...
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeJob OverviewWe are seeking an experienced leader to spearhead our Global Clinical Reporting function, driving medical writing and clinical disclosure commitments across the globe.This is a unique opportunity to lead a team of dedicated professionals, ensuring seamless collaboration with key stakeholders and optimal resource allocation to projects and...
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeAbout the RoleWe are seeking a highly skilled Senior Regulatory Professional to join our team in Hørsholm, Denmark. As a key member of our Global Regulatory Affairs, Safety & Pharmacovigilance department, you will be responsible for managing various regulatory activities and ensuring compliance with EU regulatory procedures.Key ResponsibilitiesPrepare...
-
Clinical Reporting Leadership Opportunity
3 weeks ago
Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full timeAbout ALKALK-Abello is a global pharmaceutical company specialising in allergy immunotherapy.We offer an attractive working environment for individuals seeking personal and professional growth.
-
Hørsholm, Hørsholm Kommune, Denmark Emply Denmark Full timeAbout the RoleAs a Principal Medical Device Design Transfer Specialist, you will be responsible for leading design transfer activities within the medical device sector. You will work closely with R&D, Quality Assurance (QA), and suppliers to ensure seamless design transfers following established procedures.Main ResponsibilitiesYou will act as the primary...
-
Hørsholm, Hørsholm Kommune, Denmark Brinch & Partners Full timeAn accomplished leader is sought to spearhead Operational Technology initiatives and drive business transformation at ALK.The successful candidate will oversee the transition from SCADA to a new platform, leading a team of 10 skilled engineers in delivering support across the entire production site in Hørsholm.Reporting directly to the Senior Director for...
-
Design Transfer Engineering Specialist
2 weeks ago
Hørsholm, Hørsholm Kommune, Denmark Emply Denmark Full timeAbout the RoleWe are seeking a highly skilled Design Transfer Engineer to join our team at Emply Denmark. This is an excellent opportunity for a talented professional to take the lead on transferring medical device designs to production sites.As a key member of our team, you will work closely with R&D, Quality Assurance (QA), and suppliers to ensure a smooth...
-
Process Development Specialist
3 days ago
Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full timeJob Description:We are seeking a highly skilled Process Development Specialist to join our team at ALK-Abello. This is an exciting opportunity for you to work on the development and optimization of manufacturing processes for allergen extracts.About the Role:This role will involve designing, evaluating, and reporting on development studies, including...
-
Senior Manager
1 month ago
Hørsholm, Hørsholm Kommune, Denmark VELUX Group Full timeCompany OverviewThe VELUX Group is an international, family-owned business with a strong financial foundation. We strive to create a sustainable future through innovative technology and social responsibility.We are committed to reducing our carbon footprint and promoting healthy living spaces. Our goal is to enable people to live healthier lives by providing...
-
Hørsholm, Hørsholm Kommune, Denmark Gubra ApS Full timeJob OverviewGubra ApS is an innovative contract research organization (CRO) and biotech company dedicated to excellence in drug development. We're seeking a talented HR Partner to join our team, playing a key role in shaping the future of our organization.About the RoleThis exciting opportunity involves driving recruitment processes from start to finish,...
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full timeAt ALK, we offer an exciting opportunity for a Principal Scientist to join our Drug Substance Development department. As a key member of the team, you will be responsible for the preparation of CMC documentation, including design, execution, data processing and reporting of development studies.The position involves participating in CMC development projects...
-
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeUnlock a Rewarding Career as Medical Device EngineerAre you passionate about developing innovative medical devices? Do you thrive in a dynamic team environment?We are seeking an experienced Medical Device Engineer to join our team at ALK-Abelló A/S, a global pharmaceutical company specializing in allergy immunotherapy.About the Role:This is a unique...
-
Senior Scientist for Protein Development
2 months ago
Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full timeWe are seeking an experienced Senior Scientist to join our team in Hørsholm, Denmark. The successful candidate will be responsible for the development and optimization of manufacturing processes for protein extracts.About the RoleIn this exciting role, you will work closely with our skilled technicians to design, execute, and report on development studies....
-
Hørsholm, Hørsholm Kommune, Denmark Veluxpolska Full timeStrategic Financial Leadership OpportunityWe are seeking a highly experienced Senior Finance Manager to lead our Global Marketing organization and drive financial performance. This role combines strategic financial leadership with people management responsibilities, as you will lead a team of two finance professionals.In this role, you will provide strategic...
-
Director of Technology Excellence
2 months ago
Hørsholm, Hørsholm Kommune, Denmark VELUX Group Full timeDiscover a world of opportunities at the VELUX Group, where you can create a bright future and drive innovation in sustainable indoor living.The VELUX Group is an international family-owned business with strong financial roots, dedicated to making a real impact through its foundations. Our values, including 'courage' and 'mutual respect', guide our actions...
-
Hørsholm, Hørsholm Kommune, Denmark Velux Group Full timeThe Velux Group is a world leader in roof windows and skylights, headquartered in Hørsholm north of Copenhagen. We are a family and foundation-owned business with a long history of strong results.Key Responsibilities:As a Business Developer in Radical Innovation and New Business Development at Velux, you will support the assessment of market potential and...