Expiry Date: 10-08-2023
Category Regulatory Affairs
Job Type: Full Time
This position coordinates all activities required to produce medical writing deliverables, negotiates and manages timelines, and as required directs the work of other medical writers. A great work-life balance is guaranteed, and a strong package is available for candidates at Associate Director grade (including a strong basic salary, yearly bonus and stock plan).
Our client is an exciting and growing Cell & Gene Therapy company with a mixed early development portfolio that includes Neuromuscular and Genetic Rare Diseases. The data they have produced so far for their development programs looks to be very exciting and the company is in a strong financial position and continues to grow at a steady pace.
They are now recruiting for a senior level Medical Writer who has experience as a lead writer on both clinical and regulatory documents (ideally in early development) who has also managed and led small teams or groups of Medical Writers, which could also include consultants and vendors.
Our client also offers a collaborative and engaging working environment where Medical Writing is a strategic stakeholder. The department is fully resourced with an established and highly capable team of engaged and proactive Medical Writers.
This is a leadership position within the Medical Writing function, and you will collaborate with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.
You will also lead and manage the document preparation team through the review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed and be able to facilitate and resolve complex discussions to gain agreement. You will supervise the work of other internal medical writers and oversee contract medical writers to effectively meet company goals.
You will ensure the completion of all documents under the responsibility of Medical Writing according to agreed-upon timelines and follow up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance. It’s important that you can develop and leverage constructive relationships with cross-functional project team and work with group members to support effective team interactions and delivery of team goals.
If you are interested in hearing more about this or other roles in Medical Writing, please contact me, Theo Moore on 587.216.9302 or via email Theo@Advtalent.com, or my colleague Ivan Nash on +1-908-378-8980.