Pfizer Submission Medical Writer (Associate Director/Sr. Manager) in Groton, Connecticut
The Submission Medical Writer creates documents pertaining to clinical data and post-marketing 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.
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.
Support project teams by providing analyses of clinical data.
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.
bachelor's degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.
Able to interpret analyses of data supporting regulatory documents,
Advises teams on interpretation of relevant guidance.
Knows and interprets regulatory guidance in context of specific products and submission documents.
Is able to synthesize analyses of integrated patient data from single pivotal and multiple studies into clearly written text with no supervision.
Has extensive understanding of place of product benefit/risk in commercial and medical setting
Has extensive understanding of medical concepts of the disease and approaches to treatment
Makes decisions that may require developing innovative options to resolve complex problems relating to CDO deliverables.
Writing skills. Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
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 written English and strong functional fluency in spoken English. Knowledge of additional languages is an asset.
Personal skills. Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
Interpersonal skills. Effective influencing and negotiating skills, including, when appropriate, an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
Regulatory knowledge. Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
Software. Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred.
Statistics. Proficiency with statistical concepts is desirable.
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Additional Offer Details:
Eligible for Employee Referral Bonus
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.