Description
A key client in Massachusetts is seeking a Senior Medical Writer for a 6 month contract. An ideal candidate will be able to assume responsibility immediately with little to no supervision.RESPONSIBILITIES:
- Write clinical documents for submission to regulatory authorities included but not limited to briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical documentation, clinical overview and studies, safety update aggregate reports, integrated summaries of safety and efficacy.
- Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines and resolving project related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
- Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other department deliverables. Identify any potential project challenges to department line management and project leader including changes in plan, timeline or out of scope requests, and suggest possible resolution options.
- Provide medical editing review of draft and final documents by other writers before internal or external distribution. This includes both copyediting and content review.
- Ensure document content style adheres to FDA or other appropriate regulatory guidelines, and complies with department and corporate or client SOP's and style guidelines
- Coordinate and conduct interdepartmental team reviews and sign-off of document deliverables according to guidelines/SOP's including distribute drafts, review meetings, incorporate revisions, document key project events, and complete sign-off procedures.
- Provide training and guidance and act as mentor to less experienced departmental members.
- Supervise collection of materials by the Medical Writing staff for assembly of client deliverables.
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Assist in the development of departmental SOP's.
QUALIFICATIONS:
- BA/BS (advanced degree preferred) and at least 3-5 years medical writing experience and/or experience in pharmaceutical development.
- Strong functional literacy is essential with a strong track record of communicating complex information and analyses effectively in writing.
- Applies expert knowledge, analytical skills and knowledge of clinical and regulatory guidance.
- Able to clearly articulate scientific and clinical date in written and verbal communication.
- Able to work well in cross-functional teams, exhibiting a combination of active listening skills.
- Strong project and time management skills and capabilities
- Able interact effectively with all levels and roles of project team members
- Manage expectations and time constraints associated with authoring, resolving comments, updating and finalizing documents.