Medical Writer

Job Description

• Create documents pertaining to clinical 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 (new drug) applications (Clinical Overviews and ICH module 2.7 clinical summaries), 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 clinical teams by providing analyses of clinical data, reviews of the medical literature, and similar related activities.

Responsibilities
• Communicate clinical'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 the 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.
•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 Pharmaceutical lines including country organizations.
• If assigned by manager, serve as the clinical '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.
Position Comments visible to MSP and Supplier:

Additional Skills:Technical Skills:
• 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, formulate reasonable hypotheses, and design and execute analyses to test them.
• Oral presentation skills. Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences
• 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

Qualifications

Additional Information

Regards,

Anuj Mehta

973-967-3402