Medical Writer

Key Responsibilities

• Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
• Act as a member of clinical trial teams
• Follow and track clinical documentation milestones
• Write/edit other strategic documents, as required

Qualifications

• Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medical writer in the pharmaceutical industry
• PhD with at least 1 year experience as a medical writer in the pharmaceutical industry
• Excellent writing and effective communication skills
• Proven interpersonal, organizational and problem-solving skills in a matrix management environment
• Knowledge of FDA and ICH guidelines
• Skilled in clinical data interpretation
• Proven experience writing/supporting major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)

Preferred Qualifications

• Knowledge of drug development and regulatory requirements to guide document organization
• Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality

Compensation and Benefits

The expected base salary range for this position is $80,000 - $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.

SystImmune offers a comprehensive benefits package including:

• 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
• 15 PTO days per year, sick leave
• Plus 11 paid holidays