A career with EMD Serono is an ongoing journey of discovery: our 56,000 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.
- Ensure Compliance with all global applicable laws, regulations and internal policies regarding to Clinical Trial Transparency
- Lead different disclosure and transparency activities related to sponsored Clinical Trials
- Act as Administrator for ClinicalTrials.gov and EudraCT accounts
- Deliver updates for all posted sponsored clinical trials
- Act pro-actively on any Clinical Trial Transparency topics including but not limited to Responsible Data Sharing, Lay Patient Summaries or Policy 0070 issues to ensure compliance
- Work closely with vendors and internal stakeholders, providing guidance surrounding transparency operations and their related responsibilities
- Ensure source information is collected in a timely manner for disclosures activities and provide metrics reports related to tracking and monitoring Clinical Trial Transparency activities
- Create and maintain training materials available, and in line with recent guidelines. Deliver training on end-to-end transparency operations processes, important process changes, and other associated topics to all the stakeholders involved.
- Raise awareness of CTT transparency operations and its changing requirements within the company globally as required
- Actively participate in internal and external continuous improvement activities
- Accountable for management of the vendor/s responsible for outsourced activities related to Clinical Trial Transparency
- Support internal audit and inspection activities as required
- Oversight of activities related to Clinical Trial Transparency are performed in compliance with applicable laws, internal Policies and in accordance with global industry standards
Who you are:
- Bachelor’s degree with 8+ years of experience, Master’s degree with 3+ years of experience, or PhD degree in Biology, Chemistry, Pharmaceuticals, or related field
- Five plus years of experience in the clinical development and/or regulatory affairs, medical writing area within the biopharmaceutical industry or a contract research organization.
- Two plus years Previous experience in Clinical Trial Transparency
- Task orientated and able to prioritize them
- Ability to work independently and possessing good time management skills
- Comprehensive knowledge of ICH-GCP good knowledge of clinical disclosure rules such as FDAAA 801, EudraCT, PhRMA/EFPIA principles for responsible data sharing, etc.
- Proven project management and vendor management skills
- Strong communication skills
- Solid analytical skills
- Ability to identify risks and develop mitigation strategies or anticipate and resolve issues even in complex situations
- Excellent team player, ability to work in an international and cross‐functional environment
This role can sit in our Rockland or Billerica, Massachusetts location.
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.