Our Team, Your Impact

A Sr. Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

How You'll Spend Your Day

• Primarily works at a project level.
• Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator's brochures, health authority responses, and other submission documents (e.g., module 2.5 and modules 2.7.x).
• Compiles, analyzes, and summarizes data from various sources.
• Writes and edits clinical regulatory documents including study reports, protocols, briefing books, and other submission documents (e.g. aggregate reports, post authorization safety studies).
• Compiles, analyzes, and summarizes data from various sources.
• Conducts proofreading, editing, document formatting, and comment resolution.
• Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• May participate in the preparation/revision of document templates and SOPs.
• May train and support medical writers or external vendors/contractors on document planning, processes, and content development.

Your Skills and Experience

Education Required:

• Bachelor's in life sciences (or other related field).

Experience Required:

• University degree with a minimum of 8+ years of relevant experience; advanced degree preferred.
• Proficient as lead author writing protocols/protocol amendments, clinical study reports, investigator's brochures, and clinical summary documents (modules 2.5 and 2.7.1-2.7.4)

Specialized or Technical Knowledge Licenses, Certifications needed:

• Mastery of Microsoft (MS) Word

Functional Knowledge:

• Solid writing and editing skills of clinical regulatory documents and has competence in using software (e.g., Veeva Vault), templates, and other electronic formats. Has familiarity with industry regulations pertaining to drug development, varied therapeutic areas, statistical concepts, and company products.

Company/Industry Related Knowledge:

• Knowledge of global regulations and guidelines for document submissions including authoring style guidelines (e.g., AMA).

Job-Specific Competencies:

• Excellent English, both written and spoken.
• Strong interpersonal, critical thinking, and administrative skills with attention to detail.
• Demonstrate exceptional written and verbal communication skills to effectively convey complex scientific information to cross-functional teams and regulatory authorities.
• Foster a collaborative work environment by actively engaging with key stakeholders to gather necessary information and ensure alignment on project goals and timelines.
• Demonstrate flexibility and adaptability to work across diverse teams and manage competing priorities.
• Serve as primary point of contact among project teams with ability to lead document development process, including kick off and comment resolution meetings, and drive discussions.
• Work to agreed strategy under minimal supervision.
• Tackles difficult problems, identify issues, propose solutions, and engage others to resolve issues including escalation to management.
• Develop and maintain project timelines, track progress, and deliver assignments with quality and within timelines.
• Ensure clarity, accuracy, and compliance in all clinical regulatory documents and submissions.
• Contribute to process development and improvement activities.
• Provides input for budget and annual operational planning.

Also Good to Have

Preferred Education:

• Master's, MD, PhD, PharmD.

Experience Preferred:

• 8+ years with an advanced degree.

Salary Range

The annual starting salary for this position is between $126,320 - 157,900 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

How We'll Take Care of You

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.



Make sure to apply through our internal career site on Twist-your one-stop shop for career development