Position Title: Associate Medical Writer Director/Medical Writer III - 100% Remote
Assignment Duration: 12 Months
Hours Per Week: Initially, typically only ~15-25 hours per week are utilized for onboarding and training. If performance is strong, this position could be full-time.

Position Summary:
Leading key medical writing projects and preparing scientific and regulatory documents for clinical development of drugs and biologics.
Looking for someone at an Associate Director level of medical writing with minimum of 3 years in pharma space and Phase 1 pharmacology experience with protocols.

Qualifications & Experience:

• PhD in Life Science/Pharm D (preferred) with 5+ years of experience OR MS with 7+ years
• AMWA certification (or equivalent) preferred, specializing in Pharmaceutical Writing.
• 3+ years of medical writing in pharma, focusing on regulatory document preparation.
• Working experience in Phase 1 pharmacology. Specific experience with CNS/Neuroscience compounds.
• Strong writing skills: Convert complex data into clear, structured narratives.
• Knowledge of:
  • Drug development process & regulatory guidelines (US, ICH, international).
  • Common Technical Document (CTD) templates & regulatory documentation (IND/NDA/MAA).
  • Electronic document management & publishing systems.
• Excellent communication & leadership skills for cross-functional collaboration.
• Project management: Ability to lead teams & manage multiple deliverables independently.
• Technical skills: High proficiency in MS Word, flow diagrams, spreadsheets.
• Ability to quickly grasp complex data and deliver high-quality summaries & reports.
• Open to feedback, adaptable, and process-improvement oriented.

Background & Context:

• Highly automated compound management department using robotic instruments for sample handling and storage.
• Electronic barcodes for record-keeping and tailored sample preparation.
• Automation accelerates sample delivery and ensures consistency in sample quality (concentration & physical properties).
• These advancements are crucial for early drug discovery.

 
Key Responsibilities:

• Serve as medical writing point person for:
  • Preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other regulatory documents.
• Contribute to submission communication strategy for products.
• Interpret & summarize data from biostatistical tables into concise narrative text.
• Collaborate with cross-functional teams (Biostatistics, Data Management, Regulatory Affairs, Clinical Ops, etc.) to ensure timely report production.
• Oversee, coordinate, and review work of freelance/contract medical writers (with Director support).
• Promote innovation in medical writing processes and documentation.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.