Meet's client, a leading global pharma based out of Northern, NJ is currently looking for an Associate Director of Medical Writing to support their ever expanding pipeline of products. This position will lead a product line within either the Neurology or Oncology space and play a pivotal role in developing Medical Writing strategy. As a company that's committed to improving outcomes for patients, their families and customers, this group is also highly invested in their own employees and the workplace environment.
•Manage the clinical document portfolio for a given project (e.g., IND, NDA, BLA)
•As the compound lead, independently prepares, and at times directs the writing of PCSs, protocols and protocol amendments
•Write and oversee the preparation of regulatory documents in support of drug development including but not limited to CSRs, Protocols, IBs, narratives and DSURs/PSURs in collaboration with team members
•Liaison effectively with internal and external teams to ensure alignment with timelines and data communication plans
•Write, edit, and finalize clinical study reports, clinical summaries and overviews, eCTD summaries, study protocols, investigator’s brochures, informed consent forms, and other clinical study-related regulatory documents. When required, may occasionally be required to write non-clinical, study-related regulatory documents
•Oversee workload and manage junior and contributing writers designated to assigned projects
•Play a pivotal role in supporting the development, implementation, and improvement of document management processes and SOPs
•Extract large amounts of clinical and scientific data and translate key elements for graphical presentations
• Bachelor’s degree in life sciences; Master’s degree in life sciences, PharmD or PhD preferred
• 8-10+ years' experience writing regulatory and clinical documents; preferably within a Pharma or CRO environment
• Oncology therapeutic area experience desired; Any submission writing (NDA, BLA, MAA, etc.) in this area a big advantage
• Excellent communication skills (internal and external) and attention to detail
• Knowledge of ICH guidelines and the current AMA Style Manual; AMWA membership a plus but not required
Full job description and company details are available upon application. This position is being dealt with by Paige Pecora at Meet, call on +1 646-569-9081 or email directly at firstname.lastname@example.org to discuss further and in confidence.
You can find out more about Ryan & Meet at www.peoplewithchemistry.com