Bristol-Myers Squibb Company

Senior Scientific Writer

Location
Redwood City, CA, US
Posted
May 12, 2018
Ref
R1121914
Required Education
Masters Degree/MBA
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Job Description:

With minimal supervision, author complex nonclinical regulatory documents ensuring the coordination and integration of the scientific and regulatory input from development team members. Support the performance goals (including quality and timeliness) for submissions of relevant documents in support of INDs and NDAs. Help cultivate an organizational culture which promotes behaviors that lead to superior business performance.

Expected Areas of Competence:

1. Coordinate with DS&B/PCO scientists to generate compliant regulatory documents (study reports, IND summaries, NDA summaries, etc). Apply scientific expertise to provide critical assessment of document content ensuring the coordination and integration of the scientific and regulatory input from cross-functional team members. Review (QC) documents to ensure data integrity.

2. Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents. Work proactively with DS&B/PCO scientists and Dossier Managers to ensure timelines are met.

3. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. Act as Coordinating Author to create CARA structures and assign tasks for writing, reviewing and approving documents. Ensure compliance of documents with submission and publication standards.

4. Provide leadership in developing processes and associated guidelines relevant to authoring, as well as ensuring that DS&B/PCO scientists receive appropriate training and guidance regarding these. Generate and update Model Documents.

5. Act as Coordinating Author for Initial IBs.

6. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.

7. Review and edit documents, as required.

8. Provide feedback and/or leadership, as appropriate, in the Documentation Subteams particularly in regard to document creation and establishing timelines.

Knowledge Desired:

1. MS/PharmD/PhD in a relevant scientific discipline, or MS/BS with a minimum of 12 years (MS) to 8 years (PhD) in the pharmaceutical industry, preferably within pharmacology/drug metabolism-pharmacokinetics or nonclinical development, with a good understanding of drug discovery, drug development, drug safety, and regulatory document development.

2. Demonstrated strong writing skills as evidenced by authoring and managing the production of nonclinical submission documents.

3. Good understanding of the global pharmaceutical drug development process and requirements for authoring documents for regulatory submissions.

4. Demonstrated ability to analyze and interpret nonclinical and pharmacology data from a broad range of therapeutic areas.

5. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.

6. Sense of urgency, flexibility, and ability to prioritize or shift priorities to meet aggressive and changing timelines

7. Working knowledge of a document management system and basic knowledge of the document publishing process.

Experiences Desired:

1. Experience writing and managing the production of nonclinical documents; knowledge of regulatory documentation principles and processes.

2. Good knowledge of drug development process (preferably nonclinical development).

3. Understanding of documentation requirements related to regulatory submissions.

4. Worked successfully in a cross-functional project team; ability to facilitate discussions and decision-making with cross-functional team members.