A career with EMD Serono is an ongoing journey of discovery: our 52,000 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.
- To lead the medical writing efforts for global pharmaceutical programs. Deliverables include Common technical document (CTD) summaries and overviews in CTD format for submission to FDA and EMA, briefing books, regulatory response documents and Pediatric Plans.
- Oversee outsourcing of clinical study protocols, clinical study reports, and investigator’s brochures. You represent the department on clinical teams, lead document-related meetings, and review statistical analysis plans.
- Contribute to the overall project management and to cross-functional working groups to facilitate efficient development and finalization of regulatory documents for submission.
- Provide document strategy and organize resource needed to support an indication/program.
- Attend governance meetings for clinical study protocol discussions and proactively contribute to the development and implementation of best practices and improvements.
- Travel up to 10% will be part of this role, remote work after onboarding and with availability for onsite meetings would be possible.
- Position can be in Billerica, MA, Rockland, MA, or remote if you reside greater than a 50-mile radius from our Billerica and Rockland, MA, location.
Who you are:
- Minimum four years’ experience in regulatory medical writing strongly preferred
- Bachelor's degree with 8 years of experience, or master's degree with 3 years of experience, or PhD required
- Solid knowledge about CTD documents, clinical study reports, study protocols, and investigator brochures
- Experience in electronic document management systems.
- Strong communication and organizational skills
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.