Senior Associate Director / Associate Director, Medical Writing (Remote)
US-BI Pharma/BI USA
 Ridgefield, CT

Senior Associate Director / Associate Director, Medical Writing (Remote)

***Candidate will be hired commensurate with the level and experience***

Description:

This individual functions as the submission lead by providing guidance on submission strategy, document development, issues related to content and organization of the documents, and overall project management. The incumbent also supports the Director, U.S. Medical Writing with departmental processes and Best Practices, assumes the responsibility for the preparation of documents supporting regulatory submissions, and reviews and evaluates the work product(s) of document contributors, including contract writers. In addition to also ensuring adherence to Company standards for training, quality, and compliance, the incumbent assists with developing project timelines, assessing resource needs for documents and submissions, and advises (associates and/or direct reports) on development planning while providing coaching, mentoring, and training guidance as needed.

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

Senior Associate Director

Duties & Responsibilities:

  • Developing assigned clinical documents and meeting team and regulatory timelines
  • Expert project management for trial and project teams
  • Document quality commensurate with current adherence to accepted standards, guidances, and Company Standard Operating Procedures (SOPs).
  • Staff development (0 to 5 Direct Reports; ISP writers/QC staff):
    • Recruits, develops, coaches, motivates team
    • Ensures team is well qualified and encourage further technical and personal skills development to support career progression
  • Coordination of the Medical Writing ISP model
  • Partners with key functions to support inspection readiness, audits, doing root-cause analysis and authoring CAPAs as needed.

Senior Associate Director

Requirements:

  • Advanced degree (e.g., MS, PhD, MD) from an accredited institution is preferable plus a minimum of eight (8) years’ experience in Medical Writing, preferably in the pharmaceutical industry. Medical Writing certification (MWC) and other professional development certificates are also considered, as applicable.
  • The incumbent must have relevant medical/scientific knowledge together with medical writing technical understanding.
  • Medical writing and management expertise with a comprehensive understanding of the drug development and reporting process required for study reports, submission documents, and data transparency deliverables
  • Thorough knowledge of Good Publications Practices (GPP2) and Guidelines for Publications,
  • Solid understanding of regulatory requirements and ICH guidelines (including E3 and E6), and good knowledge of document management systems
  • Good knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements.
  • Demonstrated experience presenting to scientific and non-scientific audiences
  • Evidence of strong leadership, influencing, negotiation, project management and talent management skills
  • Efficient interpersonal communication skills in complex local and international, cross-functional matrix structures
  • Strong Project Management skills
  • Demonstrate Agility, Accountability and Intrapreneurship

Associate Director, Medical Writing

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).

Associate Director, Medical Writing

Requirements:

  • College degree plus a minimum of 6-8 years experience
    in medical writing, preferably in the pharmaceutical industry. 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. Advanced degree (e.g. MS, PhD)
    or other related qualifications (eg, Pharm D, BSN) are desirable.
  • The incumbent must have relevant medical/scientific
    knowledge, project management skills, analytical skills, knowledge of drug
    development and regulatory requirements, excellent written communication
    skills, computer skills, and 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

Who We Are:

At Boehringer Ingelheim we create value through innovation

with one clear goal: to improve the lives of patients. We develop breakthrough

therapies and innovative healthcare solutions in areas of unmet medical need

for both humans and animals. As a family owned company we focus on long term

performance. We are powered by 50.000 employees globally who nurture a

diverse, collaborative and inclusive culture. Learning and development for

all employees is key because your growth is our growth.

Want to learn more?

Visit boehringer-ingelheim.com

and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim

Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal

Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and

Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative

action employer committed to a culturally diverse workforce. All qualified

applicants will receive consideration for employment without regard to race;

color; creed; religion; national origin; age; ancestry; citizenship status,

marital, domestic partnership or civil union status; gender, gender identity or

expression; affectional or sexual orientation; pregnancy, childbirth or related

medical condition; physical or psychiatric disability; veteran or military

status; domestic violence victim status; genetic information (including the

refusal to submit to genetic testing) or any other characteristic protected by

applicable federal, state or local law.

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