Principal Strategic Medical Writer

Description

The role leads the writing of clinical and regulatory documents for drug and/or device development, in support of the company's goals.

The company develops medicines and devices across several therapeutic areas, including immunology, oncology and neuroscience, plus an aesthetics portfolio.

Responsibilities

• Write most of the clinical and regulatory documents needed for the company's drug and/or device programs.
• Organise and run review meetings, and manage the review, approval and quality control work done by other functions on these documents.
• Work closely with team members on authoring and content strategy.
• Explain the deliverables, writing process and timelines to team members.
• Hold team members to agreed project dates.
• Help shape project management approaches and build your ability to lead people toward submission goals.
• Recommend, lead or take part in putting tactical process improvements into practice.
• Build deep knowledge of US and international regulations, requirements and guidance for regulatory documents.
• Spot problems that come up during writing, propose fixes, and resolve them or escalate when needed.
• Apply therapeutic area and product knowledge to science projects and business improvement projects.
• Handle inquiries and draft responses with R&D Quality Assurance on your own, keeping documents ready for inspection.

Requirements

• At least 5 years of experience in the bio-pharmaceutical industry, at a global pharma, biotech, life science or healthcare organisation that delivers medicines or therapies to a broad market across different therapeutic areas.
• A Bachelor's degree or higher is required.
• A degree in a scientific discipline is preferred.
• Excellent written and spoken communication, with thorough command of medical and scientific terms across several therapeutic areas.
• Skill in absorbing and analysing complex data.
• Extensive experience writing and editing clinical and regulatory documents that follow guidance and regulations such as ICH guidelines and GCP.
• Familiarity with industry standards such as CONSORT and PRISMA.
• Experience writing device documents for EU and US markets is a plus.
• Advanced understanding of drug development, clinical research, study design, biostatistics, pharmacology, regulatory requirements and medical terminology, and of working with multiple functional teams and contributors.
• Strong writing skills, with the ability to convey complex scientific and medical information to different stakeholders.
• Ability to manage several projects at once and work with cross-functional teams, with strong organisation, time management and problem-solving skills.

Conditions

Pay disclosure applies to applicants in locations covered by state or local pay transparency law.

The posted range is the base pay the company in good faith expects to pay for this role at posting, based on its job grade. Actual pay within the range depends on factors including geographic location, and may fall above or below the range.

The range may change over time.

The role is open to applicants in the US and Puerto Rico only.

Equal opportunity employer, including veterans and people with disabilities.

Benefits

• Paid time off covering vacation, holidays and sick leave, plus medical, dental and vision insurance and a 401(k), for eligible employees.
• The role is eligible for long-term incentive programs.
• Bonuses, incentives and other pay or benefits are at the company's sole discretion, may change under applicable law, and are not considered earned until paid.