Associate Principal Medical Writer - United States
- The main purpose of this position is to provide medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials.
- This position interacts with other medical writers, document managers, document quality reviewers, and cross-functional teams (e.g., study management teams, clinical development teams , process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions.
- Participates on cross-functional teams and influences decision making. Leads strategy discussions related to document development.
- May make recommendations for process improvements within department and participates in discussions to implement change.
- Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision
- Represents department on clinical teams (e.g., study management teams, clinical development teams); leads document-related meetings; reviews statistical analysis plans and clinical data reports as needed
- Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format
- Participates on departmental initiatives
- 2+ yrs regulatory writing experience, consistently produces medical writing deliverables for clinical program(s)
- Strong written and oral communication skills.
- Strong organizational and meeting skills.
- Solid understanding of therapeutic area(s).
- Ability to interpret data.
- Solid understanding of standard clinical document types.
- Solid understanding of internal and external guidelines related to document preparation.
Master’s required, PhD preferred in Life or Health Science discipline
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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