Our client has a new need for a highly collaborative, Associate Director, Medical Writer to join our team located in the Greater Boston area. The position reports to the Director of Medical Writing and will lead writing responsibilities of all documentation in order to adhere to GCP, ICH guideline, and SOPs. As Associate Director, this consultant will have 1-2 reports to start and taking on additional responsibilities/reports moving forward.
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 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
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
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
6-12 months +
Must be onsite
Consultant must be onsite for the duration of the contract. Once proven, 2-3 remote days will be rewarded.
Internal Number: 3
About GForce Life Sciences
GForce Life Sciences connects highly coveted consultants to the needs of life sciences leaders. Regulatory pressures, altering market demands and healthcare refinement are changing the landscape of the global life sciences industry. Patients, providers, payers, and regulators are seeking a higher quality of care and better therapeutic benefits, along with reduced costs and enhanced transparency.
With a 98% success rate, GForce Life Sciences has worked with some of the world’s leading pharmaceutical and medical device companies to address these challenges by providing consultants to assist our clients in delivering on the promises they have made to their clients (internal and external). GForce recognizes that there is no “one-size-fits-all” approach to achieving growth and battling industry-wide challenges, therefore we begin with your specific needs and work from there to identify the consultant or team that is the best fit.
Unlike larger, “factory firms,” our boutique approach allows us to hand-pick and closely monitor the best consultants for your company and projects. Finally, we back our services with the industry’s leading technology infrastructure, assuring agile, transparent, personalized consulting solutions and business reporting intelligence.