Senior Director, Medical Writing

About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark is building a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

About the Position

The Director/Senior Director of Medical Writing will be responsible for developing and implementing medical writing strategies and operational plans to support TrialSpark’s Clinical Development activities. The Medical Writer will have responsibilities to write or facilitate the writing of key documents, with an emphasis on clinical development related documents within the Research & Development department. This team member will be the first member of a growing team and work across multiple teams to integrate the medical writing strategies and operational plans.

Responsibilities

• Leads and manages the writing, review, and finalization of clinical development documents such as protocol synopses and protocols, Investigator’s brochures (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports).
• Creates the timelines, in conjunction with the project team or relevant subteam, for completion of clinical development and pharmacovigilance related documents.
• Coordinating  input from other team members (eg, Medical, Clinical Operations, Regulatory, Biostatistics, Clinical Data Management, and other department representatives) , the Medical Writer researches, writes, and edits clinical, regulatory, and pharmacovigilance documents as mentioned above) using data provided and in a format compliant with the governing regulatory agency (EMA, FDA and ICH guidelines) and with electronic submission guidelines. 
• Acts as liaison between cross-functional department personnel to ensure that background materials are provided, timelines are communicated, and questions are answered for Medical Writing deliverables.
• Reviews work of other functional expert writers for accuracy, quality, focus.
• Facilitates internal review of materials and documents and consolidates comments from internal and external reviewers (adjudication meetings). 
• Ensures that Medical Writing deliverables are complete, well organized, and scientifically accurate, and that messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and requirements.
• Leads the development of style standards and guidelines for preparation of documents, including those submitted to health agencies, and ensures Medical Writing deliverables adhere to stylistic guidelines.
• Potentially supervises and manages external contracted medical writers to ensure quality and meeting of timelines for all clinical development  and select pharmacovigilance and/or regulatory documents as prioritized by the CMO. This could also include the coordination of working with CROs to assist in moving any of these documents to completion.
• Keeps management current on project status and provides ongoing risk assessments.
• Develops and implements continuous improvement processes for document writing processes.
• Accomplishes department objectives by managing and leading medical writing team members and contractors and deliverables.
• Develops and maintains medical writing team members by effectively recruiting, selecting, orienting, and training employees.
• Ensures all tasks are carried out in accordance with applicable principles of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory guidelines.

About You 

• Bachelor of Science Degree, as a minimal requirement. MS or PhD is highly preferred.
• 7+ years of experience in a pharmaceutical setting writing clinical protocols and/or other medical or scientific documents.
• Experience as lead writer for key documents including FDA and international regulatory submissions required
• Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (CTDs)
• Excellent critical thinking, organizational, problem solving, negotiation, and time management skills and initiative.
• Able to effectively manage multiple assignments and adapt flexibly to changing priorities.Strong communication skills with the ability to simply summarize complex information verbally and in a written format.
• Ability to work collaboratively on multi-disciplinary project teams and to proactively manage relationships with external medical writing vendors.
• Ability to lead and facilitate meetings.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.