Bristol-Myers Squibb Company

Senior Scientific Writer

Location
Princeton, NJ, US
Posted
Jul 10, 2018
Ref
R1120688
Required Education
Doctorate/PHD/MD
Position Type
Full time
To author complex documents ensuring the coordination and integrations of the scientific, medical and regulatory input from development team members. To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by Development Teams.

To author complex documents ensuring the coordination and integrations of the scientific, medical and regulatory input from development team members. To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by Development Teams.

Summary:

To author complex documents ensuring the coordination and integrations of the scientific, medical and regulatory input from development team members. To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by Development Teams.

Responsibilities:

1. Ensures that all assigned documents support the full development strategy to achieve target labeling objectives and timely approvals in key markets

2.Participates in relevant subteams(s) of the EDT, FDT or LCM team and ensures effective planning and management of timelines for all components of assigned documents

3. Participates and/or leads document prototyping sessions including the designs of data displays, documents flow, logic and consistency for assigned project prototypes; critically reviews projects specific model documents, maintains document prototypes/shell reports.

4. Documents and implements consensus at meetings to determine data interpretation and key findings/messages.

5. Authors complex clinical documents

6. Manages the review process and, on an ongoing basis, resolves issues, errors or inconsistences with pertinent team members to ensure:

• Optimal communication between authoring team and development team members

• Coordination and efficient use of messages between internal development plans IND and NDA documentation

• Timely completion and high quality of assignment documents

Education, Experience, Skills:

1. PharmD/PhD/MD in a relevant scientific discipline, or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, and good understanding of requirements for regulatory submission documents.
2. Demonstrated strong writing skills as evidenced by authoring and managing the production of Investigator Brochures (IBs) and Phase 1/2 Clinical Study Reports (CSRs).
3. Good understanding of the global pharmaceutical drug development process and requirements for authoring CSRs for regulatory submissions.
4. Demonstrated ability to analyze and interpret clinical 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. Working knowledge of a document management system and basic knowledge of the document publishing process.