Associate Medical Writing Manager

Profile

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at

www.astellas.com

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Gathers, reviews, and analyzes pertinent resources or data to produce a high-quality document. The individual creates and revises documents, using established templates and processes that meet internal and external customer needs. The writer ensures document quality in regard to correctness of structure, content, language, and/or style. The individual ensures data consistency and document integrity across the document by critically evaluating comments and incorporating them appropriately. The individual addresses all comments in collaboration with responsible content authors and scientific document lead. The individual works with scientific document lead to facilitate issue resolution, incorporates outcomes into the draft/final document and helps facilitate document approval and finalization.

Essential Job Responsibilities:

Drafts documents by integrating cross-functional input and ensures that the document communicates the information necessary to satisfy internal and external audience needs (Level II). Level I writer assists the Level II writer and more senior staff by creating a needed document component or subcomponent (e.g., End-of-Text Table, citation list, appendix).

Interacts with members of document working group/author team/document scientific lead in order to complete assigned responsibility (Level II). Level I writer generally interacts within the medical writing discipline.

Revises documents (Level II). A Level I writer may perform some aspects of the revision tasks under the oversight of a Level II writer or more senior staff. Revision tasks include:

Ensuring data consistency and document integrity across the document by critically evaluating comments and incorporating them appropriately.

Addressing all comments in collaboration with responsible content authors and scientific document lead.

Facilitating issue resolution in collaboration with the document scientific lead.

Documenting course of action (incorporation or reason for non-incorporation) for comments/edits for reviewers.

Drafting an updated document.

Successfully partners with Astellas staff.

May perform editorial work.

Facilitates document approval and finalization.

Quantitative Dimensions:

Successful and timely completion of assigned task(s) affects complex documents that may be key to maintaining timelines for a drug development program.

Uses provided templates, writing guides and established processes.

Organizational Context:

Project track, writer with document creation responsibilities under review of more senior staff or designee.

Uses provided templates, writing guides and established processes

Requirements

Qualifications:

Required

BA/BS degree or equivalent.

With 7 years relevant experience or 5 years with MS/MA (Level II)

With at least 5 years relevant experience (Level I)

Able to perform independently.

Without appreciable direction regarding technical aspects (Level II).

Able to self-direct completion of assigned responsibilities and tasks (Level I).

Preferred: At least 5 years (Level II) / 3 years (Level I) experience in writing regulated documents.

In addition, for Level II qualifications include the following:

Technical expert for at least one type of regulated document / document component (generally IND/IMPD or NDA/MAA component, Investigator's Brochure, Briefing Document, Clinical Study Report) prepared by Medical Writing (document type relevant to assignment).

With direction of staff or designee, able to build persuasive and scientific-based arguments that support the regulatory or other purpose of the document and able to incorporate principles of content re-use.

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

401(k) match and annual company contribution

Company paid life insurance

Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

Long Term Incentive Plan for eligible positions

Referral bonus program

#LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

IL, Northbrook

Category

Data Science

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/