Pharmaceutical company is hiring an Associate Director Medical Writing for their Waltham Massachusetts location.
We are a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, we apply our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our track record for successful drug development is evident from the more than 20 marketed drugs that use our proprietary technologies, and perhaps most clearly exemplified by the five key commercial products propelling our growth. These are breakthrough products in major disease areas, such as schizophrenia, addiction, and multiple sclerosis.
We are in an exciting phase of growth that few biotechnology companies achieve, with our diversified portfolio of commercial products and an exciting late-stage pipeline. We are moving ahead with global capabilities, an established approach to innovation, world-class manufacturing, financial strength, and our experienced and dedicated people.
We have the need for a highly collaborative, Associate Director, Medical Writing to join our team based in Waltham, MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure adherence to GCP, ICH guidelines, and Alkermes SOPs.
· Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, and Project
· Management in planning and preparation of clinical and regulatory documents
· Act as Lead Medical Writer at Project level in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
· Represent Medical Writing on cross-functional clinical teams and actively participate in NDA submission planning and documentation
· Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames
· Mentor junior Medical Writers
· Experience in clinical documents related to late phase studies.
· NDA experience with active contribution in planning and preparation of summary documents is required.
· Facilitate Clintrials.Gov results postings
· Ability to independently plan and prepare Clinical and Regulatory Documents
· Excellent interpersonal and communication skills
· Flexibility/adaptability to work in a fast-paced and dynamic environment
· Proficient with MS Office and other related software programs
· Experience in managing people and projects
· Experience in working with cross-functional teams and engage/escalate to ensure quality deliverables in planned time frame
MINIMUM EDUCATION AND EXPERIENCE:
· Bachelors Degree; Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
· 10+ years of industry experience as Medical Writer
· Participation as writing lead on at least one NDA/MAA submission
· Experience in psychiatry/ neurology/cardiovascular/ analgesic therapeutic areas is a plus