Associate Director, Medical Writing


Associate Director, Medical Writing (Remote)-210257

Description:

Executes medical writing activities for projects in accordance with applicable regulatory regulations and Boehringer-Ingelheim requirements under the supervision of the Sr. Associate Director or Director of Medical Writing. Assumes primary responsibility for preparation of documents supporting major regulatory submissions and other documents as assigned, and assists the manager in coordinating and evaluating the activities of other contributors (including contract writers and CROs). Participates on relevant project teams and task forces, provides guidance on issues related to document preparation and production, and project- or therapeutic area-specific guidance related to content and organization of specific documents. Responsible to develop associates (development plans, training, coaching and mentoring, as appropriate).

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.

Duties & Responsibilities:

  • Contributes to development of global regulatory documentation strategy and execution of tactics. Conceptualizes and develops medical communications for message-driven, concise reviewer-friendly clinical documents in order to support regulatory agency review. Coordinates medical writing/regulatory submission progress against global regulatory strategic communication plans.
  • Writes or co-ordinates writing and reviews of clinical trial reports, narratives, clinical trial protocols, local working instructions, submission documents (ISS, ISE, CO, RMP), investigator brochures, annual IND updates, and other documents as needed. Reviews DPP and SAP as needed. Estimates resources needed and communicates with Director of Medical Writing.
  • Establishes target dates for completion of assignments. Communicates with management when timelines are threatened. Establishes and enforces quality standards for documents.
  • Manages external vendors as needed.
  • Participates in process improvement and training initiatives. Responsible for supervising appropriate medical writing staff in execution of operational functions including tracking and coordinating activities. Assists in professional development of medical writing staff.
  • Follows governmental regulations and company SOPS for document preparation.

Requirements:

  • College degree from an accredited institution, plus a minimum of six to eight (6-8) years of experience in medical writing, preferably in the pharmaceutical industry.
  • Advanced degree (e.g., MS, PhD) or other related qualifications (e.g., Pharm D, BSN) are desirable.
  • Evidence of the skills necessary to manage submissions.
  • Evidence of the skills to manage a group of 0-5 medical writers.
  • Evidence of depth of knowledge in one of BIPI’s therapeutic areas desirable.
  • Must have relevant medical/scientific knowledge together with medical writing technical understanding across an array of regulatory documents.
  • Must have relevant medical/scientific knowledge.
  • Project management skills.
  • Analytical skills.
  • Knowledge of drug development and regulatory requirements.
  • Excellent written communication skills.
  • Computer skills.
  • Ability to work as part of a team.
  • *The above are necessary to provide the depth and breadth of understanding of drug development issues.

Eligibility Requirements:

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.


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Boehringer Ingelheim

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