20 days old

Director, Medical Writing

Pfizer
Collegeville, PA 19426
Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.



What You Will Achieve Your strong documentation skills will be an asset for the team. You will help us draft and scientific reports for submission to regulatory agencies or in-company use.



As an advisor and an expert, you will be able to build and leverage constructive relationships across the organization to achieve your division's goals and objectives. Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.



How You Will Achieve It



+ The Submission Medical Writer (Director) creates documents pertaining to clinical data and postmarketing safety data to support product development, license application, and post-marketing maintenance on behalf of and in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization applications (Clinical Overviews and ICH module 2.7 clinical summaries, Integrated Summaries of Efficacy and Safety), and responses to clinical and safety questions from regulatory authorities.

+ Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents. Support project teams by providing analyses of clinical data.

+ Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues.

+ Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project.



Responsibilities:



+ Communicate 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.

+ Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.

+ Drive document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Deliver 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.

+ If leading a team of other authors (internal or external), be accountable for timely delivery of high quality, fit-for-purpose documents to the project team.

+ Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance.

+ Understand relationships and dependencies between documents and analyses produced for regulators.

+ Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.

+ Develop and sustain constructive relationships within other Pfizer lines including country organizations.

+ If assigned by manager, serve as the Medical Writing 'point of contact' for all document issues for a given product or set of products.

+ Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line.



Qualifications Education: Master's degree or doctorate or qualification in life sciences or related field preferred. Alternatively, bachelor's degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.



+ A minimum of 5 years in medical writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs).

+ Able to interpret complex analyses of data supporting regulatory submissions

+ Serves as an authority on the interpretation of regulatory guidance and their significance in a broad range of situations.

+ Acknowledged within CDO as an expert in synthesizing analyses of integrated patient data from single pivotal and multiple studies into clearly written text.

+ Has advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area

+ Participates in discussions of benefit/risk assessment and regulatory impact of documents and analyses. Makes decisions by identifying innovative options or multiple solutions to complex problems.

+ Recommends courses of action to management and senior leaders that impact the discipline, department or line.



Must-Have



+ Bachelor's Degree in life sciences or related field

+ Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area

+ Ability to establish and maintain professional and productive working relationships

+ Excellent interpersonal and communication skills

+ 10+ years' expereince.



Nice-to-Have



+ Master's degree or doctorate in life sciences or related field



This role can be located at listed locations or remote based.



\#LI-PFE

\#LI-Remote



**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

Categories

Posted: 2020-10-05 Expires: 2020-11-20

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Director, Medical Writing

Pfizer
Collegeville, PA 19426

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