Nonclinical Medical Writer

Nonclinical Medical Writer (Part-time)

Location: Remote, no preference on location

• Candidates must be W2

Length: 12 months

Manager Note: Work will be up to 20 hours/week but some weeks may be 0 hours

Summary:

The Nonclinical Medical Writer is responsible for development and management of medical writing deliverables that support the nonclinical regulatory writing portfolio and is capable of working independently to achieve goals. The Medical Writer is responsible for managing documentation and ensuring consistency as required in order to execute on the writing deliverables across the nonclinical and clinical portfolio. Serving as a link among key functions, the Medical Writer ensures that critical information is communicated with clarity, precision, and accessibility. This individual works primarily with nonclinical SMEs and also cross-functionally to prepare and update documents, including nonclinical written and tabulated summaries (Module 2.6), nonclinical overview, and Investigator Brochures to support product development. The Medical Writer will help develop processes, manage and maintain processes, and assist in development of templates. This role will help influence Nonclinical Medical Writing best practices. This position reports to the Senior Director of Medical Writing, Development Operations and is remote.

Duties/Responsibilities:

• Serve as a Program/Submission expert, to be able to develop strategies/plans and managing projects, to complete multiple documents for nonclinical regulatory deliverables.
• Provide expertise to cross-functional team members regarding medical writing processes, standards, and initiatives.
• Coordinate and author nonclinical regulatory documents (e.g. nonclinical written and tabulated summaries (Module 2.6), nonclinical overview (Module 2.4), and Investigator Brochures), ensuring the coordination and integration of scientific and regulatory input from development team members.
• Demonstrate mastery of complex writing assignments across therapeutic areas or multiple projects.
• Participate in relevant IND or CTA subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
• Define content document prototypes and shells to various cross-functional teams.
• Be recognized as a significant scientific contributor and subject matter expert in preparation of nonclinical documents.
• Apply in-depth knowledge of nonclinical medical writing and therapeutic area/investigational product to support pipeline projects.
• Produce high-quality and timely documentation in line with expectations. Interpret and apply knowledge of regulatory/compliance/scientific requirements, using own judgment, prior work experience, and broad appreciation of impact on other disciplines.
• Provide input on planning for document organization and content and cross-functional integrated timelines.
• Coordinate quality control review of documents.
• Coordinate comment resolution meetings.
• Work collaboratively with colleagues across functions to achieve results.

Qualifications/Requirements:

• Bachelor’s Degree Required, Advanced Degree preferred.
• 7 years of experience in the research, medical, pharmaceutical, or biotechnology industry.
• Minimum of 5 years of experience as a medical writer, preparing regulated documents in the pharmaceutical and/or biotech industry, with focus in oncology or rare diseases.
• Technical expertise in Microsoft Office, Adobe Acrobat, ability to learn and use document management systems and SharePoint.
• Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond nonclinical and clinical development.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities.
• Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals.
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
• Sense of urgency and ownership in performance of duties.
• Interpersonal skills that promote a collaborative and productive team environment.