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Medical Writing Therapeutic Area Lead (Director)

Employer
Pfizer
Location
Working from Home
Start date
Aug 9, 2022

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Discipline
Clinical, Medical Writing
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

ROLE SUMMARY

  • The Medical Writing Therapeutic Area Lead (Director-M) role is responsible for providing strategic, scientific, and operational expertise to drive the planning and preparation of 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. Has responsibility for deliverables for one or more therapeutic areas and establishes asset and therapeutic area-level strategies.
  • Manages and trains internal staff and oversees external vendor staff to support delivery of high-quality deliverables.
  • Serves as a subject matter expert in clinical regulatory writing who can represent the Medical Writing group on internal cross-functional initiatives.
  • Is facile with innovative problem solving, peer influence, and change management.

ROLE RESPONSIBILITIES

  • Provides strategic and operational leadership to direct preparation and completion of documents. Demonstrates subject matter expertise. Functions as an integral member of the Medical Writing Leadership Team.
  • Directs the work of internal medical writers such that projects are completed in line with internal and external requirements and in a timely manner to meet business needs. Provides coaching and training to Pfizer colleagues to support performance management and career development.
  • Oversees work performed by Medical Writing vendors. Provides training on Pfizer document development processes to vendor staff. Develops forecasts and participates in governance meetings.
  • Effectively interacts within a matrix organization to forecast, manage, and prioritize document deliverables to support portfolio goals for one or more therapeutic areas. Promotes open communication regarding medical writing status and issue resolution. Manages risk appropriately to enable innovative solutions that maintain high-quality deliverables.
  • Implements strategies and process improvements to support operational efficiency, quality, and innovation.

BASIC QUALIFICATIONS

  • Bachelor’s degree, preferably in a life science discipline.
  • BS/BA +15 years, MS/MA +13 years, or PhD +10 years of experience in medical writing or related field.
  • Understanding of the role of each member of cross-functional team.
  • Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
  • Ability to manage documents of greater complexity and/or variety.
  • Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
  • Adapts to change as needed.
  • Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.
  • Ability to identify complex problems that require management or cross-functional input for resolution in timely manner.
  • Develops innovative options or multiple solutions to resolve complex problems that impact project completion and/or document content strategy. Demonstrates critical and rapid decision-making.
  • Ability to mentor more junior colleagues.
  • Proven experience in a project management role, leading a team or function.
  • Develops others in line with both evolving business needs and colleague's personal development plan, including managing low performers through coaching and training.
  • Demonstrated ability to ensure accountability of direct reports and medical writing teams.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
  • Influences all levels and roles in cross-functional, global teams to develop strategy, solve complex problems, and make process improvements.
  • Ability to identify a process needing improvement, propose innovative solutions, and lead a cross-functional team to address issue.
  • Ability to represent Pfizer externally to influence change industry-wide.
  • Extensive knowledge of the Pfizer Global Style Guide and all relevant SOPs (associated forms and work instructions) and process training that relate to medical writing deliverables and quality review of deliverables.
  • Conceptualizes, develops and implements improvements to SOPs, templates, procedures, job aids, and onboarding and training material for function.
  • Ability to manage and lead vendor-based resourcing.
  • Demonstrates knowledge of Pfizer business divisions and interrelationships between them.
  • Proposes and implements change in accordance with business needs.
  • Participates as a member of corporate committees (eg, process improvements, strategic planning process oversight, standards, outsourcing, alliance partnerships).
  • Ability to project resourcing needs, manage existing resource distribution, make hiring decisions, and develop succession plan, with guidance.
  • Prepare and manage budgets, with guidance.
  • Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.
  • Advises team on interpretation of global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
  • Ability to take complex regulations and interpret them into business requirements for documents to be delivered to health authorities.
  • Comprehensive understanding of the drug development process and how medical writing documents support development at different stages.
  • Advanced understanding of medical concepts of the disease and current standard treatments as well as other investigational treatments.
  • Extensive understanding of place of product benefit/risk in commercial and medical setting.
  • Analytic skills. Ability to examine data and formulate reasonable hypotheses.
  • Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses.
  • Language skills. High fluency in spoken and written English.
  • Knowledge of how to use publicly available databases (e.g. PubMed, DailyMed, FDA and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.
  • Able to consolidate, analyze, interpret, and summarize data from multiple data sources, including the global safety database, with no supervision.
  • Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, without guidance.
  • Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.
  • Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel).
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • Some travel (~5%) across GPD sites for face to face meetings, if necessary. Depending on location may need to accommodate global teleconference calls across different time zones.

PREFERRED QUALIFICATIONS

  • Advanced degree (MS/MA/PhD) is preferred.
  • A minimum of 5 years in Medical Writing with experience with NDAs/MAAs, IND/CTAs, and regulatory disclosures is preferred. Supervisory experience is preferred.
  • Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.

Other Job Details:

  • Eligible for Employee Referral Bonus: YES

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment:Remote

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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