Associate Director, Medical Writing – Experimental Medicine

This is a fully remote position, open to applicants in United States.

📋 Description

• Take on the position of project medical writer throughout early clinical development.

• Collaborate with various functions, establish timelines, and design and implement document strategies.

• Draft essential clinical documents for designated projects.

• Supervise regulatory documents prepared by internal or external medical writers.

• Engage in scientific and regulatory discussions within project teams.

• Exhibit expertise in the designated therapeutic area.

• Create clinical documents at both project and study levels for phase transitions and regulatory approval.

• Organize document and submission timelines and formulate document strategies.

• Address and integrate review feedback while managing timelines.

• Coordinate across functions to ensure timely and successful finalization of documents.

• Guarantee the quality and punctuality of documents assigned to external providers through oversight, training, and cost management.

• Enforce medical writing standards in the governance of external providers.

• Participate in international cross-functional working groups and contribute to global SOP development.

• Represent the Experimental Medicine Medical Writing function in cross-functional working groups.

• Engage with leadership, influence strategic goals, and ensure execution.

• Cultivate and disseminate knowledge in major indications and key document types.

• Mentor and train fellow medical writers.

• Offer expert guidance to other functions.

• Apply global, local, and regional regulatory guidelines to clinical documents.

• Adhere to applicable SOPs and company policies.

⛳️ Requirements

• An advanced degree (e.g., PharmD, PhD, MD) from a recognized institution is preferred, along with a minimum of four (4) years of relevant experience in regulatory medical writing/scientific communications within the healthcare sector.

• A Master’s degree from an accredited institution with at least six (6) years of experience in scientific communications and/or regulatory medical writing will also be considered.

• A Bachelor’s degree from an accredited institution with a minimum of eight (8) years of experience in scientific communications and/or regulatory medical writing will be taken into account.

• Previous experience as a project medical writer.

• Proficiency in regulatory writing, including protocols, clinical trial reports from early clinical phases, investigator’s brochures, and other clinical documents.

• Familiarity with international writing standards and conventions.

• Awareness of the business implications of timelines for key clinical documents.

• Comprehension of medical concepts, statistics, pharmacokinetics, and pharmacodynamics.

• Knowledge of the clinical development process and pertinent global and local regulatory guidelines.

• Understanding of requirements for regional and local marketing approvals.

• Ability to independently and effectively convey complex clinical information in writing.

• Capacity to understand and interpret clinical data.

• Capability to manage projects across regions and in matrix environments, including time management and oversight of external providers.

• Proficient in managing multiple tasks and varying workloads.

• Effective communication skills within international cross-functional teams.

• Ability to navigate conflicting interests.

• Potential to contribute to process enhancements.

• Skilled in word processing and presentation software.

• Exceptional written and verbal English proficiency.

• Scientific and analytical thinking abilities.

• Strong interpersonal and social skills.

• Proficient presentation capabilities.

• Diplomatic skills and cultural sensitivity.

• Experience working globally on clinical documents submitted to health authorities in major regions (US, EU, Asia) with knowledge in the assigned therapeutic area is preferred.

• Expertise in the assigned therapeutic area and its clinical standards, including innovative medical or statistical approaches, is desired.

🏝️ Benefits

• Role-specific discretionary bonuses may be available.

• Relocation assistance may be offered.

• Medical coverage is provided.

• Dental coverage is included.

• Vision coverage is available.

• Opportunities for retirement savings are offered.

• Paid time off is provided.

• Paid holidays are included.

• Disability insurance benefits are available.

• Life insurance benefits are provided.

• Additional company-sponsored benefits may be available.

• Opportunities for international collaboration.

• Engage in meaningful work with support for mobility, networking, and work-life balance.