RegDev is looking for a Senior Medical Writer Consultant to join our team. This team member assumes primary responsibility for drafting and editing clinical protocols, investigator brochures, clinical study reports, informed consent forms, IND/NDA/BLA clinical summaries, ISE/ISS, and scientific manuscripts for clients.  Coordinates the activities of other contributors (including internal and external subject matter experts).  Participates in determining writing approach, style, and developing timelines while ensuring documents comply with global regulatory requirements.

Essential Duties and Responsibilities

• Translates complex scientific and clinical data into clear, accurate, and regulatory-compliant documents for use in drug development and regulatory submissions to global health authorities. Projects may include Phase 1-4 clinical protocols, investigator brochures, clinical study reports, informed consents, clinical summary sections of INDs, NDAs, BLAs, etc.
• Develop and manage granular project timelines.
• Adjudicate team comments and lead meetings.
• Interpret medical literature and present concepts effectively and clearly.
• Act as lead medical writer on projects to author and edit based on client’s goals and needs.
• Ensure compliance with global regulatory requirements and guidelines such as FDA, EMA, ICH, and GCP.
• Conduct quality control checks to ensure document and data accuracy.
• Manage multiple projects simultaneously and change direction to meet clients’ shifting needs.
• Work in collaboration with other functional groups (e.g., Clinical Research, Biostatistics, Regulatory), check for accuracy, coordinate reviews, collate reviewers’ comments, coordinate approval, and prepare final submission-ready documents.
• Conduct necessary bibliographic research in support of scientific communications.
• Use content expertise and understanding of study design and conduct to interpret scientific and statistical data.
• Evidence of medical writing career development as demonstrated by certificate in relevant expertise e.g., American Medical Writers Association, relevant Drug Information Association training or other applicable association.
• Familiarity with ICJME’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals a plus.

Job Requirements and Education

Education:

• Bachelor’s degree in a science-related field, Master’s degree or a Doctoral level degree preferred.

Experience:

• At least 8-10 years’ experience as a medical writer in biotech / pharmaceutical industry generating clinical protocols, reports, investigator brochures, dossiers, regulatory filings, and other regulated scientific publications compliant with regulatory requirements. Strong understanding of drug development and a basic understanding of regulatory affairs. Must have strong data interpretation skills, knowledge of clinical trial protocols, and statistical concepts.

Other Skills and Abilities: 

• Excellent and diplomatic written and verbal communications skills.
• Proficiency in MS Word, PowerPoint, Excel, MS Project, Smartsheet, or other relevant software.
• Strong familiarity with statistical concepts and interpretation of data.
• Ability to function independently with minimal guidance.
• Strong organizational and problem-solving skills.
• Ability to lead multiple concurrent writing projects.
• Demonstrate initiative and ability to deal with complex situations.
• Excels at communication and collaboration skills with executive teams.
• Effective people- and project management.
• Exceptional writer and editor.
• Highly detail-oriented.
• Strong understanding of clinical development.
• Able to adhere to tight deadlines and shifting priorities.

ADA Notations

• Ability to sit for long periods of time, handling, feeling with hands, reaching with arms.
• Regular communication (hearing/speaking).
• Travel required as needed.
• Lifting up to 25 lbs.
• Routine home and onsite office duties including computer keyboard use.
• Vision requirements include close vision and ability to focus.
• Noise conditions range from quiet to moderate – home office conditions variable.

EQUAL OPPORTUNITY EMPLOYER