Associate Principal, Medical Writer - United States
|External Posting Title||Associate Principal, Medical Writer|
|Job Description||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.
1. Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision
2. 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
3. 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
4. Participates on departmental initiatives
|Location||Cambridge, MA, US|
|Qualifications||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.
|Education||Master’s required, PhD preferred in Life or Health Science discipline|
|About Biogen||Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today has the leading portfolio of medicines to treat multiple sclerosis, 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. Biogen also manufactures and commercializes biosimilars of advanced biologics. |
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. With a strong affiliate presence and a network of distribution partners, Biogen has established a global footprint that allows us to capture the greatest value for the products we develop.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
Nearest Major Market: Cambridge
Nearest Secondary Market: Boston
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