A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 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.
At EMD Serono, The Medical Writing Project Manager will facilitate the global, cross-functional Integrated Clinical Review Committee (ICSC), Therapeutic Area Review Boards (TARBs) and First in Human Review governance boards. These committees are responsible for overseeing protocol design and operational planning of clinical studies.
- Arranging all logistical and technical needs for meetings
- Producing and distributing minutes, tracking actions, and reporting
- Training members and study teams on the governance process and acting as a first point of contact for process-related questions
- Developing and maintaining systems for calculating and reporting KPIs as well as templates and committee charters
- Managing governance SharePoint sites, ensuring appropriate confidential access
- Ensuring inspection readiness for all governance decisions.
Who you are:
- Bachelor’s in Biology, Chemistry, or other Science Discipline
- 3+ year’s experience in pharmaceutical/biotechnology industry
- Proven training ability
- Knowledge of Clinical Study Protocols
- Knowledge of computer applications particularly Adobe Acrobat, Microsoft Word, PowerPoint, Outlook, SharePoint and knowledge of interaction of programs
- Initiative and ability to work with minimal supervision
- Ability to work well with others at all levels in the organization in high pressure situations
- Strong organizational and communication skills
This role can sit at our Rockland or Billerica, MA site
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!
Curious? Apply and find more information at https://jobs.vibrantm.com
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 their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.