A career with EMD Serono is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
Who we Are
EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.
Who You Are
The Medical Writing Lead will be a core member of the Clinical Operations Team (COT), to serve as primary point of contact for the Clinical Operations Team on medical writing deliverables and to provide advice on Medical Writing issues to Global Project Team members and help to resolve problems. The Medical Writing Lead will also be responsible for writing strategic submission documents (e.g., IND, briefing books, ISS, ISE) and enabling regulatory submissions for EMD Serono programs. The Medical Writing Lead will provide project management expertise working with CRO medical writers, key decision makers and internal team members to manage continuous process improvements, issue escalation, workload projections and provide technical expertise. The Medical Writing Lead will partner and work cross functionally internally with: Other GCO functions; Global Regulatory Affairs; Drug Safety; GDM Clinical Development Center; Non Clinical Development; Global Biostatistics; GRED Platform Clinicians; Other R&D functions. The Medical Writing lead will have:
- BS degree with 8 years of experience, MS degree with 3 years of experience or PhD
- Medical writing experience is required
- Demonstrated knowledge and in Medical Writing (IND, briefing books, ISS, ISE, CTPs, CTRs, IBs Narrative, PSURS, DSRs, Literature Writing etc.) is also required.
- Demonstrated project management skills is required
- Knowledge with writing requirements is required.
- Expertise with electronic publishing is strongly preferred.
- Understanding of regulatory requirements across major geographies is also required.
- 20% domestic or international travel.
- Proven experience in working in a high volume environment handling multiple tasks
- Excellent time and priority management, able to work efficiently under pressure.
- Works accurately and to detail
- Strong organizational skills
- Fluency in English.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.