Senior Manager/Associate Director Medical Writing

Role Summary

The Medical Writer (Senior Manager/Associate Director) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.

The successful candidate will understand the principles of scientific writing, writing with the audience in mind and conveying messages in a clear and concise manner. Analyses, interprets, and distils data and other information to create documents.

Be able to apply advanced knowledge of relevant regulatory requirements and corporate policies as well as work experience to assess document requirements and identify information gaps or other potential issues.

Job Responsibilities

• If assigned by manager, serves as the Medical Writing ‘point of contact’ for all document issues for a given asset or set of assets.
• Produces documents in conjunction with vendors as needed
• Is facile with innovative problem solving and peer influence.
• Drives decision making about data presentation strategies to support advance planning of documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
• Communicates Medical Writing’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
• Manages all aspects of document development process and leads project teams through process. Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line.
• Aligns with department management to set strategy for meeting department goals.
• Develops and maintains project timelines. Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.
• Independently authors complex documents that are compliant with relevant internal processes and standards as well as external regulatory guidance.
• Takes appropriate risks to resolve any identified issues.

Basic Qualifications

• Develops innovative options to resolve complex problems that impact project completion
• Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses. Language skills
• Comprehensive understanding of the drug development process and how medical writing documents support development at different stages
• Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones
• Analytic skills. Ability to examine data and formulate reasonable hypotheses
• Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, with guidance
• Ability to collaborate with cross-functional peers across therapeutic areas for improving a process, not limited to medical writing
• Comprehensive understanding of medical concepts of the disease and current standard treatments.
• PhD + moderate experience in medical writing or related field
• Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel)
• Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing
• MS/MA + strong experience in medical writing
• Ability to multi-task and work effectively under pressure, with strong organizational and project management skills
• Able to interpret analyses of data supporting regulatory/clinical documents and to summarize in clearly written text with minimal guidance from team members
• BS/BA + strong experience in medical writing or related field
• Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data
• Knowledge ofhow to use publicly available databases (eg, PubMed, DailyMed, FDA and EMA sources and guidelines es) for literature and information mining to support document content and how to cite such information appropriately
• Bachelor’s degree, preferably in a life science discipline
• Ability to manage documents of greater complexity and/or variety
• Ability to collaborate successfully with all levels and roles in cross-functional, global teams
• Ability to identify complex problems that require management or cross-functional input for resolution in timely manner
• Adapts to change as needed
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Participates in discussions of benefit/risk assessment and regulatory impact of documents and analyses
• Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function
• Ability to mentor more junior colleagues
• Understanding of the role of each member of cross-functional team

Preferred Qualifications

• Advanced degree (MS/MA/PhD) is preferred
• Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred

Work Location Assignment: Remote - Except Greece Which is On Premises

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Medical